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Colorado Paid Clinical Trials

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Denver, Colorado

Velocity clinical research, denver.

Velocity Denver services the Denver Metro area with a population of 2.9 million and rapidly growing. Denver’s experienced staff maintains high quality standards and enrollment on all their trials.

Located along a major roadway, the Denver site is in a high traffic shopping center. With access to a large population, the Denver team excels at meeting enrollment goals on all their studies. Ample parking is available for patients. The site is also located 2 miles from a local hospital.

All trials conducted at the site are performed in accordance with ICH and FDA guidelines, and in compliance with GCP. The Denver team is committed to being a resource for study participants, to providing the highest quality of patient care with compassion and kindness, and to advancing medicine through research.

Velocity Clinical Research, Denver 401 W Hampden Pl Suite 240, Englewood, CO 80110

Phone: (303) 293-3733

Email: [email protected]

Find a Clinical Trial in Denver Visit VelocityClinicalTrials.com or follow us on Facebook for study updates and more.

Improve lives by making clinical research accessible to all.

Our Mission

Improve the clinical research process to accelerate the delivery of new therapies and provide exceptional care to our community.

Our experienced research team in Denver

The Velocity Denver team of physician investigators and clinical research professionals are experienced clinical researchers. All physicians are board certified in their specialty area(s) and all research staff is trained in clinical research regulations, including GCP and HIPAA. Training records and certifications are maintained. Our clinical team is dedicated to conducting quality research in a professional and caring environment and strives on collecting quality data.

Theresa O’Lonergan, PhD, MA

Site Director Theresa O’Lonergan, PhD, MA has been in clinical research and research administration for 25 years. Dr. O’Lonergan earned her PhD in clinical investigations from the University of Colorado. After retiring from the CU School of Medicine, she held Research Integrity Officer positions in several large health systems and joined Velocity in 2021.

Robert Williams, MD

Principal Investigator Robert Williams, MD is a board-certified family practitioner with additional certifications in Geriatric Medicine and Palliative Care & Hospice Medicine. After receiving his medical degree from Tulane University, Dr. Williams completed his residency at UCLA Ventura County Medical Center before completing fellowships in Palliative Care & Hospice as well as Geriatric Medicine at the University of Colorado. In addition to his extensive experience in conducting clinical research as an investigator, Dr. Williams has been practicing medicine for over a decade.

Denver facility features

The Velocity Clinical Research, Denver facility is designed for the ease and comfort of study participants and to allow optimal efficiencies in performing clinical trials. Features at this site include:

• Private examination/consultation rooms
• Comfortable patient reception areas
• Secure monitoring rooms or workstations with phone & high-speed internet access
• Multiple individual & secure workstations for research staff
• Electronic data capture (EDC) capabilities
• Secure record storage
• CLIA certified research laboratory
• Ambient and refrigerated centrifuge
• Secured & temperature controlled investigational product storage with pharmaceutical refrigerator & freezer
• Freezers equipped for laboratory specimens at -20 & -70 degrees Celsius
• Backup generator/power source in the event of site power loss
• Standard medical equipment, including ECG, digital and analog scales

Quality. Continuity. Velocity.

Denver, Colorado

Velocity clinical research, denver.

Velocity Denver services the Denver Metro area with a population of 2.9 million and rapidly growing. Denver’s experienced staff maintains high quality standards and enrollment on all their trials.

Located along a major roadway, the Denver site is in a high traffic shopping center. With access to a large population, the Denver team excels at meeting enrollment goals on all their studies. Ample parking is available for patients. The site is also located 2 miles from a local hospital.

All trials conducted at the site are performed in accordance with ICH and FDA guidelines, and in compliance with GCP. The Denver team is committed to being a resource for study participants, to providing the highest quality of patient care with compassion and kindness, and to advancing medicine through research.

Velocity Clinical Research, Denver 401 W Hampden Pl Suite 240, Englewood, CO 80110

Phone: (303) 293-3733

Email: [email protected]

Find a Clinical Trial in Denver Use the dropdown to browse current studies in Denver.

Follow Velocity on Facebook for company updates and more.

About Velocity Clinical Research

155,000+ people have a joined a study at velocity.

Many people enjoy the study experience and have joined several clinical trials at Velocity.

Velocity has decades of research experience

With sites that were established as long ago as 1986, Velocity has experts who have supported clinical trials for decades.

Velocity studies are led by healthcare professionals

All clinical trials conducted at Velocity are overseen by the U.S. Food and Drug Administration (FDA).

Our experienced research team in Denver

Every clinical trial is overseen by a Principal Investigator – a physician who is responsible for the rights, safety and welfare of the study participants. All physicians at Velocity are board certified in their specialty area(s) and all research staff is trained in clinical research regulations, including GCP and HIPAA. Our clinical research team in Denver is dedicated to conducting quality research in a professional and caring environment.

Theresa O’Lonergan, PhD, MA

Site Director Theresa O’Lonergan, PhD, MA has been in clinical research and research administration for 25 years. Dr. O’Lonergan earned her PhD in clinical investigations from the University of Colorado. After retiring from the CU School of Medicine, she held Research Integrity Officer positions in several large health systems and joined Velocity in 2021.

Robert Williams, MD

Principal Investigator Robert Williams, MD is a board-certified family practitioner with additional certifications in Geriatric Medicine and Palliative Care & Hospice Medicine. After receiving his medical degree from Tulane University, Dr. Williams completed his residency at UCLA Ventura County Medical Center before completing fellowships in Palliative Care & Hospice as well as Geriatric Medicine at the University of Colorado. In addition to his extensive experience in conducting clinical research as an investigator, Dr. Williams has been practicing medicine for over a decade.

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Learn more about participating in a clinical trial.

Liver disease is a growing concern across the globe, especially in the United States, where the prevalence of conditions like Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis … Read more

What is Informed Consent?

Joining a clinical trial is an important decision. Most participants come to the clinic with questions about clinical trials and what joining one could mean. This is why every study … Read more

Clinical Trial Phases: What Happens in Phase 1, 2, 3 and 4?

Clinical trials are research studies of medications, vaccines, medical devices, procedures, diagnostics (tests), and other health-related products. These studies involve participants (also known as patients, volunteers, or subjects) to determine … Read more

Participant Story: Maryann, a Research Study Participant at Velocity

What led you to participate in a research study? I saw a roadside poster near the university in my neighborhood [for a vaccine study] and called Velocity. My first experience … Read more

Complete the form to start your clinical trial journey in Denver

Why join a clinical trial?

• Help advance medicine
• Learn about potential new medicines in development
• Get study-related medical exams at no cost
• Receive compensation for participating (available amounts may differ for each study)

After you submit your info, a Velocity staff member will review your info. They will contact you to talk about the study, or others that may be right for you.

Health insurance is generally not needed to join a clinical trial.

Remember, there is never an obligation to join — we're here to help you make the best decision.

Submit your info

By entering your email address and/or phone number on this form, you represent that you are at least 18 years of age and consent to receiving communications (e.g., call, SMS, text, and/or email) from Velocity and/or the research site(s) involved with the clinical trials that appear on this website. Message and data rates may apply. You may reply with STOP to a text message. For full details, refer to Velocity's privacy policy and website terms of use . Submissions on this website are not monitored 24/7. Do NOT submit personal health or medical information on this form. If you are enrolled in a trial and have questions, please call your research site.

Sponsors and CROs

From the leading pharma companies, to the most pioneering biotech startups, Velocity supports those who are exploring new frontiers in human health. Whether you’re ready to conduct a single-site study or a complex, high-volume clinical trial, trust Velocity.

It all starts with people like you.

Without clinical trial participants, it would not be possible to create new medicines, treatments, and cures..

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Department of Neurology

Welcome to neurology clinical research.

Sponsors/CROs looking to conduct research at our site? Contact us!

2023 Research Study Statistics :

We offer a variety of clinical research :.

• Drug Studies
• Non-drug Treatments and Interventions
• Device Studies
• Observational (blood draw studies, questionnaire studies)
• Patient-reported Outcomes
• Imaging (MEG, MRI, fMRI, PET scan)
• Quality Improvements
• Translational Lab and Tissue Bank

Many studies are Investigator-Initiated, or designed by our outstanding physicians. From observing their patients, these physicians pose important questions to investigate the difficult questions of neurological disorders. Other studies receive funding and support from pharmaceutical industries, private foundations, private donors, and government agencies such as the National Institute of Health (NIH).

Explore our Neurology Research Laboratories :

• Alzheimer's Disease and Cognition
• CU Neuro-Magnetic Laboratories
• Neuroimmunology: Autoimmune Inflammatory Disorders of the Central Nervous System
• Neurovirology: Role of Varicella Zoster Virus in the Central Nervous System
• Neurovirology: Epigenetic Regulation of Varicella Zoster Virus
• Neurovirology: In Vivo Models of Varicella-Zoster Virus Neurotropism
• Neurovirology: Virus Infections of the Central Nervous System

New to Clinical Research?  

Learn more   about clinical research by visiting the following resources:  

• What are Research Studies? by the University of Colorado Anschutz Medical Campus Research Studies Team
• The CISCRP Community Resources  webpage contains a number of contact information-containing resources available to anyone seeking information about clinical research, both general and disease-specific.
• Clinicaltrials.gov Glossary of Common Site Terms
• The  National Institutes of Health (NIH) - Clinical Trails and You
• PubMed  is a free (as in money) resource supporting the search and retrieval of biomedical and life sciences literature with the aim of improving health–both globally and personally.

Common Terms:

• Arm: a group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
• Clinical study: a research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies.
• Clinical trial: another name for an interventional study.
• ClinicalTrials.gov identifier (NCT number): the unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
• Eligibility criteria: the key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.
• Informed consent: a process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.
• Intervention/treatment: a process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
• Observational study: a type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.
• Placebo: an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
• Principal Investigator   (PI): the person who is responsible for the scientific and technical direction of the entire clinical study.
• Protocol: the written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
• Research Services Professional  (RSP) : the title of clinical research coordinators at the University of Colorado. The RSP coordinates research visits and helps the PI carefully manage the participant’s care.
• Sponsor: the organization or person who initiates the study and who has authority and control over the study.
• U.S. Food and Drug Administration (FDA): an agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.

*all above definitions were copied from the Clinicaltrials.gov Glossary of Common Site Terms

Research is critical in helping to advance our knowledge of neurological diseases in order to best care for our patients. We also welcome Healthy Volunteers  to participate in our studies!  Join us and become a part of the Neurology Clinical Research family as we aim to become a Center of Research Excellence!

For questions about our clinical research, please contact the Neurology Research Recruitment Team at  303-724-4644 or  [email protected] .

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Clinical research by subspecialty.

Healthy Volunteers

Click to explore!

Neuroimmunology

Autoimmune Encephalitis, Bio and Tissue Banks, Exercise Studies, First-degree Relatives of People with Multiple Sclerosis (MS), Healthy Volunteer Studies, Newly Diagnosed MS, Primary Progressive Multiple Sclerosis (PPMS), and Relapsing and Secondary Progressive Multiple Sclerosis (RSPMS). Click to explore!

Movement Disorders

Ataxia, Dystonia, Huntington’s Disease (HD), Multiple System Atrophy-Parkinsonian subtype (MSA-P), and Parkinson’s Disease (PD). Click to explore!

Neurobehavior

Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Lewy Body Dementia (LBD), and Mild Cognitive Impairment (MCI). Click to explore!

Neuromuscular

Amyotrophic Lateral Sclerosis (ALS), Becker Muscular Dystrophy (BMD), Charcot Marie Tooth Disease (CMT), Diabetic Neuropathy (DN), Facioscapulohumeral Muscular Dystrophy (FSHD), Limb Girdle Muscular Dystrophy (LGMD), Myasthenia Gravis (MG), Myotonic Dystrophy Type 1 (DM1), and Spinal Muscular Atrophy (SMA). Click to explore!

Focal Epilepsy, Idiopathic Generalized Epilepsy (IGE), Primary Generalized Tonic-Clonic Seizure (PGTCS), and Temporal Lobe Epilepsy (TLE). Click to explore!

Headache/Migraine

Chronic Migraine. Click to explore!

Neurovascular

Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL). Click to explore!

Neuro-Ophthalmology

Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOG-AD) and Neuromyelitis Optica Spectrum Disorder (NMOSD). Click to explore!

Get Connected

If you think you may be eligible for one of these studies or if you would like more information, please fill out our Neurology Research Interest Web Form or contact us at  N [email protected]  or 303-724-4644.

Neurology (SOM)

CU Anschutz

Research Complex II

12700 East 19th Avenue

Aurora, CO 80045

303-724-4328

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Improving quality of life for ourselves and others through the work that we do!

Our doctors and staff are dedicated research specialists that have a combined 130+ years of clinical research experience. We specialize in Phase I – IV trials covering multiple therapeutic indications, including healthy volunteers.

Dedicated to providing clinical trial opportunities in the Colorado Springs area.

Care. Comfort. Safety.

Why are clinical trials important?

Without clinical trials, the advancement of medicine isn’t possible. Clinical trial volunteers play a important part in the development of medicines, medical devices, vaccines, etc. Choosing to participate in a clinical trial is an important personal decision, and there are resources available to answer any questions you may have.

Friendly. Professional. Compassionate.

Join a research study.

The purpose of clinical trials is to find new and improved methods of treating different diseases in the future.

Meet Our Experienced Staff

Our staff is dedicated to providing provide a warm, welcoming enviroment for our patients.

Partner With Us

We specialize in Phase I – IV trials covering multiple therapeutic indications, including healthy volunteers.

We offer the following services:

• Phase I; PK Studies
• Phase IIa; IIb Studies
• Phase IIIa, IIIb Studies
• Phase IV Studies
• Skin photography
• Electronic CRF submission
• Protocol review
• Protocol design
• Investigator meetings
• Skin biopsy
• Fluid collection
• Access to x-ray, audiograms, EKGs

• Generalized Anxiety Disorder
• Multiple Sclerosis (All Indications)
• Post Traumatic Stress Disorder (PTSD)
• Major Depressive Disorder (MDD)
• Obsessive Compulsive Disorder (OCD)
• Celiac Disease
• Adhesive Capsulitis (Shoulder)
• Osteoarthritis (Knee)

Mountain View Clinical Research is accepting new studies in the fields of neurology, pain management, osteoarthritis and many other conditions. Learn More

We are conveniently located in the Cherry Creek area at 3955 E Exposition Ave. Suite 104 in Denver.

The team at Mountain View Clinical Research has been conducting clinical trials for over 20 years. Together they combine their skills and knowledge of medicine, clinical research and regulations. Study participants are treated with the utmost...  Read More

Would you like to participate in a clinical study? Call our office to speak to one of our coordinators to find out more. Call us at (720) 941-9363.

Mountain View Clinical Research

3955 E Exposition Ave Suite104 Denver, Colorado 80209 

720-941-9363

• Sponsors & CRO's

Mountain View Clinical Research has been wonderful in helping me manage my MS. The staff is very professional and makes you feel like you are family. I have done quite a few research studies with them.  Even if I have not been in a study but needed something from them, they were very helpful.

- Lynnette, Denver

Help advance medical knowledge by participating in a clinical trial that addresses your indication.

  Mountain View News

                testimonials.

Mountain View Clinical Research Celebrates 20 years!   Read More

  Meet the Team

Call Us:  (720) 941-9363

​​ Bringing Science and Society Together  

  Current Studies

Send us a message, enrolling now.

Mountain View Clinical Research adheres to all COVID precautions and recommendations by the CDC.

Office Hours

Monday - Friday: 7:00 - 5:00 pm.

Saturday: Closed

Sunday: Closed

​ ​Clinical Trials

Convenient location.

Copyright ©  Mountain View Clinical Research . All rights reserved.

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Advancing Bio Technology, Research & Commerce

Bioscience is one of Northern Colorado’s fastest-growing industries and is a critical component of Colorado’s overall cluster infrastructure. Bioscience companies in the area are excelling in the medical devices and diagnostics, and pharmaceuticals sectors, as well as making unprecedented strides in agriculture biotechnology. With strong industry support including world-class federal and privately funded research labs, university programs and centers of entrepreneurship, Northern Colorado is a leading region for bioscience advancements.

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• Northern Colorado BioScience Cluster
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• Rocky Mountain Innosphere
• Cargill Specialty Seeds and Oils Innovation Center
• Colorado State University of Animal Reproduction & Biotechnology Laboratory
• Colorado State University Flint Animal Cancer Center
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Featured Companies

Therapeutic Expertise

Participate

Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.

• Portfolio management and asset valuation
• Early development and innovation
• Integrated clinical development
• Approval and access
• Value substantiation lifecycle management

HOW WE DO IT

• Operational excellence
• Delivery models
• Building patient insights into assets, profile and claims
• Portfolio Optimization
• Asset Valuation and Indication Prioritization
• Early Evidence Review
• Model-Based Drug Development
• Integrated Development Strategy and Planning
• Phase I Clinical Trials
• Proof of Concept Studies: Phase IB-IIA
• Patient Engagement Strategy and Enrollment Solutions
• Patient Inclusion
• Site Alliance Network and KOL Engagement
• Protocol Optimization
• Regulatory Strategy
• Market Access Strategy and Delivery
• Biomarker and Genomic Medicine Strategy
• Clinical Trial Supply & Logistics
• Medical Communications
• Phase IIB-IV Clinical Trials
• Real World Evidence
• Protocol-Driven, Customized Site Solution Strategy
• Regulatory Strategy, Submissions, Compliance, and Outsourcing
• Clinical Development Technology Optimization
• Global Regulatory Submissions and Outsourcing
• Compliance and Risk Management
• Real-World Evidence, Market Access Strategy and Planning
• Regulatory Compliance, Drug Safety and Pharmacovigilance
• Lifecycle Optimization
• Leveraging AI and digital in clinical development
• Biotech Clinical Trial Solutions
• Gain an advantage through FSP

Parexel Biotech provides the end-to-end capabilities you’ll need to succeed. We're fast, flexible, and dedicated to impacting patient lives.

Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.

• Neuroscience
• General medicine
• Infectious disease & vaccines
• Inflammation & immunology

Cross-Therapeutic Expertise

• Cell & gene therapies
• Rare diseases

Our experts help you stay at the forefront of the industry - and ahead of change.

New Medicines, Novel Insights

• Advancing rare disease drug development
• Accelerating development of cell and gene therapies
• Achieving patient-guided drug development

Discussions on Diversity

• Chapter 1 Bridging the Gap
• Chapter 2 Beyond the Binary

The Regulatory Navigator

• BIOSECURE Act: Implications for US-based drug developers
• Exploring ICH Q5A revision 2
• Potency assurance for CGT products: FDA's new draft guidance

Latest Report

New Medicines, Novel Insights: Achieving patient-guided drug development

Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions.

INTERESTED IN PARTICIPATING?

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HEAR FROM REAL PATIENTS

• Patient Stories

TRIAL SITES

Want to collaborate with us to offer clinical trials at your site? We would welcome the opportunity to discuss.

We are one of the largest CROs in the world, speeding life-changing medicine to market by engaging patients With Heart ™. Learn about who we are, what we do, and what we believe.

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What can we help you find today?

The perspectives and opinions expressed in this material represent those of the patient advocate only and should not be considered a solicitation, promotion or advertisement for any services of Parexel, or any drugs or therapies, including those under development. Participating in clinical trials for investigational medicines offers patients potential benefits, such as access to cutting-edge treatments and expert medical care, while contributing to medical research. However, risks may include side effects, unpredictable outcomes, and time commitment. Careful assessment of these factors helps patients make informed decisions. The content of this material, including graphics, images and text, is provided for informational purposes only and does not constitute medical advice, diagnosis or treatment. Please consult your healthcare professional for medical advice. The patient advocate has provided their consent for the use and distribution of this content.

Patient Story

• Cell & Gene Therapy
• Rare Diseases
• Inflammation & Immunology
• Neurosciences

One night, while watching TV with her husband, Robyn felt a lump in her neck.

She had large B-cell lymphoma — an aggressive cancer diagnosed in 150,000 patients each year globally.

As a doctor, she knew the risk. She got a CAT scan, looked at the images, and her world stopped.

Four years later the lymphoma returned. Robyn’s care team prescribed a further six cycles of a brutal chemotherapy, followed by an autologous stem cell transplant (ASCT) and external beam radiation. Robyn’s ASCT treatment was further complicated by septic shock requiring a stay in intensive care.

Robyn entered remission again, but it was short-lived, with the lymphoma returning nine months later. Treatment options for Robyn were now bleak and limited.

Robyn immediately sought treatment. With her husband by her side, she underwent many rounds of chemotherapy and went into remission.

Feeling defeated, she found a clinical trial for car t-cell therapy, a new treatment that reengineers white blood cells to target and eradicate cancer., she thought this was her last chance., a week after receiving treatment, her lymph nodes shrunk. within three months, there was no evidence of the disease., today, she’s cancer free — and sharing her experiences to help us better meet the needs of patients like her in our cell and gene therapy trials., lives can change when you design cell and gene therapy trials with speed and precision..

• Utilize the right experts, focused on the right indications
• Access even hard-to-find patient populations
• Pinpoint the perfect sites for your trial
• Satisfy global regulations, to get your treatment to market safely and quickly

What we do, we do

Our Experts

Our cell and gene therapy specialists collaborate to help get your innovative treatments to patients like Robyn faster.

MORE EXPERTS

Steve Winitsky

Vice President, Tech...

Stefan Zietze

Executive Director, ...

Hicham El Bariqi

Director, Cell & Gen...

Jingke Yang, M.D., Ph.D.

Global TA Section He...

Chris Learn, Ph.D., PMP

Vice President, Cell and Gene Therapy, Center of Excellence

With 20+ years of trial execution and team management experience, Chris leads development for our cell and gene therapeutic area. He reinforces our patient-first focus to help ensure your trials are designed to meet patient needs.

"Being able to capture and understand the patient’s perspective — not just as a patient, but as a person — and use their insight to guide my decisions is what it means to work With Heart™."

Our diverse experiences ensure you get the expertise you need, no matter the indication.

Our experience with CAGT clinical trial sites around the world allows us to accelerate study start-ups.

• North America
• South America
• Middle East & Africa

Access to global EMR data enables us to pinpoint the perfect sites for your trial.

Our cross-functional team overcomes any technical, logistical, and strategic challenges.

Our highly tailored recruitment and retention strategies drive access to even hard-to-find patient populations.

What can we do to help you change patient lives?

See CAGT capabilities Visit all therapeutic areas Explore CAGT careers

Want our latest insights for cell and gene therapy?

Ready to speak to someone on our team?

Are you a patient interested in a clinical trial?

We focus on patients, because they inspire us to deliver better trials, faster than ever . So we can make a difference for more patients like Robyn.

Who we are,, parexel is proudly among the world’s largest clinical research organizations.

A dedicated CRO providing the full range of Phase I to IV clinical development services  and leveraging the breadth of our clinical, regulatory and therapeutic expertise , our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders and sites to design and deliver clinical trials with patients in mind , to make clinical research a care option for anyone, anywhere.

Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

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Autonomix Enters into Agreement with NoiseFigure Research, Inc. to Develop Next Generation of its Proprietary Microchip

THE WOODLANDS, TX, April 25, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, today announced that it has entered into a service agreement with NoiseFigure Research, Inc. (NFR), a premier application specific integrated circuits (ASICs) service provider.

As part of the agreement, Autonomix will work with NFR to assess its ASIC microchip and upgrade the chip to its second-generation in preparation for human clinical testing in the Company’s planned pivotal trial in 2025. Additionally, NFR will evaluate a subsequent version meant to enable commercial production volumes.

Lori Bisson, Chief Executive Officer of Autonomix said, “This collaboration with NFR is an important step in the evolution of our technology and simple approach to a procedure for pain management and other indications. The proprietary ASIC is the real intelligence in our technology that enables us to detect neural activity, amplify nerve signals, convert signals to digital form, and geolocate nerves, with approximately 3000 times greater sensitivity than the closest available sensing technology in the market today. We look forward to working closely with the NFR team and leveraging their expertise.”

The Company’s catheter-based technology is being developed to do two things: sense neural signals associated with pain or disease and precisely target those nerves for treatment. Autonomix believes this technology is a better alternative to the current approaches commonly used today, where doctors either rely on systemic drugs like opioids that lose effectiveness and have unwanted side effects or treat suspected areas blindly in hopes of hitting the right nerves, an approach that is often inaccurate and can miss the target and even cause collateral damage to surrounding parts of the body.

The Company is initially developing its technology to address pancreatic cancer-related pain. Current approaches, primarily relying on opioids or invasive ethanol injections, can provide only limited relief and may lead to risky side effects. For more information about the Company’s technology, please visit autonomix.com .

About NoiseFigure Research, Inc.

NFR is a leader in democratizing access to application-specific integrated circuit (ASIC) services in addition to recent offerings into the manufacturing of PCBs, substrates, and flexible electronics. Since our inception in 2009, NFR has been dedicated to empowering developers with world-class custom ASICs and ASIC services. Our expertise spans Analog, RF/uWave, and Mixed Signal chip design, including packaging and related materials. By adding PCB, substrate, and flexible electronics manufacturing to our portfolio, we further lower the barriers for innovation. Our products and services cater to a wide range of industries, including Commercial, Military, Government, and Aerospace, enabling customers to realize their visions. We are deeply committed to supporting our customers' endeavors and are excited to continue driving advancements in technology and manufacturing. 

About Autonomix Medical, Inc.

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum.

For more information, visit autonomix.com and connect with the Company on X , LinkedIn , Instagram and Facebook .

Forward Looking Statements

Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward looking statements in this press release include, without limitation, the timing of the Company’s planned pivotal trial. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’

Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law.

Investor and Media Contact JTC Team, LLC Jenene Thomas 833-475-8247 [email protected]

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New science and medical research hub opens in atlanta.

Georgia Institute of Technology and the Trammell Crow Company are transforming Atlanta’s booming skyline with the launch of the first phase of Science Square, a pioneering mixed-use development dedicated to biological sciences and medical research and the technology to advance those fields. A ribbon-cutting ceremony is planned for April 25. 

“The opening of Science Square’s first phase represents one of the most exciting developments to come to Atlanta in recent years,” said Ángel Cabrera, president of Georgia Tech. “The greatest advances in innovation often emerge from dense technological ecosystems, and Science Square provides our city with its first biomedical research district, which will help innovators develop and scale their ideas into marketable solutions.” 

Science Square’s first phase includes Science Square Labs, a 13-story purpose-built tower with state-of-the-art infrastructure to accommodate wet and dry labs and clean room space. To promote overall energy efficiency as well as sustainability, the complex houses a massive 38,000-square-foot solar panel. The solar panel system is in addition to an energy recovery system that extracts energy from the building’s exhaust air and returns it to the building’s HVAC system, reducing carbon dioxide emissions. Electrochromic windows, which tint during the day to block ultraviolet rays and steady the temperature while also controlling the environment — key in research labs — are also featured throughout the building.   

Equipped with technologically advanced amenities and infrastructure, Science Square Labs serves as a nexus for groundbreaking research, enabling collaboration between academia, industry, and startup ventures. Portal Innovations, a company specializing in life sciences venture development, is among the first tenants to establish operations at Science Square, as Atlanta takes center stage as the country’s top city for research and development employment growth. 

The opening of the complex’s first phase, just south of Georgia Tech’s campus and totaling 18 acres, also features retail space and The Grace Residences developed by High Street Residential, TCC's residential subsidiary. The 280-unit multifamily tower, already welcoming tenants, is named in honor of renowned Atlanta leader and Georgia State Representative Grace Towns Hamilton who spent many years championing this community.

Beyond its scientific endeavors, Science Square embodies Georgia Tech’s commitment to uplifting the local community. By collaborating with organizations like Westside Works, Science Square aims to empower residents through targeted workforce development initiatives and economic opportunities.  

“This mixed-use development adds immense value to Atlanta’s west side and will lead the development of pioneering medical advances with the power to improve and save lives,” President Cabrera added.  

Additional Media

Related links

• Georgia Tech Breaks Ground on Science Square
• https://news.gatech.edu/news/2022/04/14/construction-begin-science-square-life-…

Angela Barajas Prendiville

Director, Media Relations

Georgia Institute of Technology  

Ayana Isles

Senior Media Relations Representative