clinical research organisation deutschland

• Medical Devices
• Advanced Therapy Medicinal Product
• Neurology / Psychiatry
• Cardiovascular
• Ophthalmology
• Gastroenterology
• Gynecology / Urology
• Endocrine / Metabolic Disorders
• Dermatology
• Rare Diseases

Representative Services

• Regulatory Affairs
• Medical Writing
• Project Management / Monitoring
• Quality Assurance
• Data Management / Biostatistics
• Medical Safety

Pharmacovigilance

• Memberships / Accreditations
• Corporate Development
• Locations / Contact

FLEXIBLE EXPERTS & RELIABLE SOLUTIONS

In clinical research, smallest details matter. Our commitment is to highest standards in quality, service and client confidentiality.

Minimizing Risks for maximum Benefits.

Keeping a watchful eye on the safety of your products, we collect and report your safety data. Because safety comes first.

Your Premium European Legal Representative.

Operating in all of the European Union and Switzerland, we are your link to successful business throughout Europe.

We are a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies.

Deutsche Biotechnologietage

FGK participates with Edgar Fenzl, Ursula Türcke and Martin Krauss at DBT in Berlin, Germany.

FGK Clinical Research GmbH Acquires Clinicology Ltd., Expanding Territorial Footprint in Europe

Press Release

Our experience spans multiple fields of medical indications.

Clinical studies with medical devices require a contract research organization that is familiar with the specific regulatory requirements.

▷FGK has broad experience in conducting clinical trials with all forms of biologics including cell therapy, ATMP and GMO.

As full service contract research organization, we have completed numerous clinical trials spanning a broad variety of indications in oncology.

CRO experienced in neurology − Our clinical research experts have extensive experience with novel therapeutic approaches

New challenges in dental clinical trials require profound support for study centers. ▷FGK can support sponsors with this

▷FGK has broad experience in cardiology and in vascular indications, including clinical research with e.g. stents, balloons and ablation systems.

▷FGK is a CRO with broad experience in infectious diseases research. Your clinical study can benefit from expert knowledge gained in various indications

▷FGK supports sponsors of clinical studies in ophthalmic indications. ✓ A contract research organization with experience in opthalmology

Clinical study support for pulmonology research. ▷FGK has an established network of investigational sites specialized in different methodologies

Based on many years of comprehensive experience in the design and conduct of clinical trials in various gastroenterological indications we can provide sound advice and service

▷FGK Clinical Research is experienced in conducting studies in classical indications of gynecology and urology.

Endocrine and metabolic diseases span a highly diversified range of conditions. ▷FGK has performed international Phase I studies up to post market studies

Clinical studies in dermatology use key imaging tools in evaluating efficacy endpoints. ▷FGK can advise on the best approach and support trial conduct

Clinical trials in rare diseases present challenges that need to be addressed early in the study design. ▷FGK knows how to overcome common obstacles

FGK Clinical Research GmbH

Heimeranstrasse 35 80339 Munich · Germany

T: +49 89 893 119 - 0 F: +49 89 893 119 - 20

info @ fgk-cro . com

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• phone: +49 2173-10947-0
• mail: [email protected]
• P.R.I.S.M.A.-CRO GmbH, Elisabeth-Selbert-Str. 19, 40764 Langenfeld; Germany

P.R.I.S.M.A.

Clinical research organization, is now a part of labquality, p.r.i.s.m.a. is a german clinical research organization (cro) and dedicated to support the european part of the pharmaceutical and biotech industries’ clinical development programs., the company has been established in 2007 by three senior founders, bringing together a wealth of experience from major global clinical research organizations as well as from the pharmaceutical industry. since october 2023 p.r.i.s.m.a is part of labquality. p.r.i.s.m.a. and its experienced professionals further strengthen labquality’s clinical trial offering in the pharmaceutical and biotech markets. the acquisition is in line with labquality’s strategy to build an international full-service contract research organization (cro). p.r.i.s.m.a. provides comprehensive services for designing, managing, monitoring and reporting on phase 1 – 4 clinical research. our reputation is based on competence, personal commitment and an effective client-oriented cooperation. we are proactive, focused and consultative partners, delivering expert knowledge to every project, ensuring convincing solutions for your clinical trial. we offer the following customized services either on a “stand alone” basis or as part of an integrated “full-service” solution:, study start-up.

• Feasibility for national and pan-European clinical trials
• Development of study design and study protocol
• Preparation of all study related documents
• Recruitment of study sites
• Contract and budget negotiations with study sites
• Insurance handling
• Training of the study personnel
• Planning and conducting of investigator meetings

Regulatory Affairs

• Request for authorization of clinical trials at Competent Authorities
• Submission of clinical trials to Ethics Committees for favorable opinion
• Submission of substantial and non-substantial amendments to the Competent Authorities and Ethics Committees
• Ongoing communication with Competent Authorities and Ethics Committees
• Submission of annual safety updates to the Competent Authorities and Ethics Committees
• Submission of the clinical study report to the Competent Authorities and Ethics Committees

Study Conduct

• Clinical project management
• Vendor management
• Site management
• Support of subject recruitment
• Review of subject eligibility
• Clinical monitoring (1 -4)
• Payment of investigator and/or study personnel fees
• Study supply management
• Drug safety
• Medical monitoring

Project Rescue

• Clinical trials are the most costly phase of development. Increasing costs, growing complexity, longer timelines due to false starts,delays, issues and obstacles during the startup phase and study conduct. P.R.I.S.M.A. offers project-specific rescue strategies regarding the implementation of the relevant corrective steps and trouble-shooting in order to get a project back on track.

Legal Representative Services

• Article 74 of the EU Clinical Trial Regulation (CTR) requires every sponsor conducting a clinical trial in the European Union not being established in the Union, to ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation.
• We offer Legal Representative Services to ensure that international clients without a registered affiliate in any of the EU member states meet their legal requirements as the European representation is essential for the purpose of conducting clinical research projects in the EU.

These services can support both European and locally managed projects.

Why p.r.i.s.m.a., • lean and agile organization – full attention and dedication to each awarded project          →quick decisions, fast action          →minimal staff turnover since inception • creative and driven to provide highly individualized client-oriented services • strong and experienced team • proactive communication • committed to quality • proven client satisfaction.

• P.R.I.S.M.A.-CRO GmbH Elisabeth-Selbert-Str. 19 40764 Langenfeld; Germany
• [email protected]
• Phone: +49 2173-10947-0
• www.prisma-cro.com

• Labquality is the global forerunner in healthcare and health-tech quality. Labquality is a Finnish company providing services to healthcare and medical technology industries, promoting quality and patient safety via independent quality assessments, certification, regulatory consulting, and training services. Labquality offers external quality assessment schemes that are designed for medical laboratories and point-of-care testing sites to monitor and improve their performance and quality. Labquality also offers global regulatory and quality services for medical devices and in vitro diagnostics. Currently, Labquality has 7,000 customers in over 60 countries. The staff consists of 80 professionals, and our offices are in Finland (Helsinki, Tampere, and Oulu) and Germany (Kassel and Langenfeld). Labquality is part of COR Group.
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• Publications
• Informationen über klinische Forschung und eine Übersicht über aktuelle klinische Studien finden Sie auf unserem Studienportal: CRO-Studienportal

Studienteilnehmer

Welcome to the future of translational and early clinical development.

Scientifically driven with access to multiple centres of excellence.

• First Time in Human
• Proof of Concept
• Novel Biologics
• Biosimilars
• Small Molecules
• Medical Devices and Health Technologies
• Nutritional Products
• Cardiovascular Diseases
• Dermatology
• Endocrinology
• Gastroenterology
• Gynaecology (Women's Health)
• Haematology & Oncology
• Immunology & Regenerative Medicine
• Infectious Diseases
• Inflammation
• Metabolic Diseases
• Ophthalmology
• Psychiatry & Psychosomatic Medicine
• Renal Impairment
• Respiratory Diseases
• Rheumatology

Customisable full service underpinned by the highest quality clinical conduct.

• Clinical Conduct
• Scientific & Regulatory Consultancy
• Protocol Development
• Regulatory & Ethical Committee Submissions
• Routine Laboratory
• Biomarker Laboratory
• Project Management
• Data Management
• BioStatistics
• Medical Writing

World-leading patient and healthy volunteer recruitment capabilities.

• Patient Recruitment
• Healthy Volunteer Recruitment

Delivering the best value solution for early clinical development.

• Case Studies
• Scientific Expertise
• Operational Excellence
• Recruitment

Charité Research Organisation is ideally placed to help you realise the full potential of your translational and early clinical development programmes

Charité Research Organisation offers a unique combination of in-house and external capabilities to conduct studies with unprecedented scientific expertise 

Charité Research Organisation supports you all the way from study conceptualisation to clinical conduct and beyond

Charité Research Organisation makes the impossible possible - single-centre solutions for early clinical studies in patients, not just healthy volunteers

Charité Research Organisation always aims to exceed sponsor expectations by delivering better quality more cost-efficiently and in less time

Charité Research Organisation is a Contract Research Organisation focused on helping its clients move development projects from First Time In Human to Proof of Concept as quickly and efficiently as possible. Based in Berlin, at the very heart of Europe, CRO was founded in collaboration with Charité - Universitätsmedizin Berlin. Read more

What’s new at CRO

White paper | therapeutic concepts for obesity and related diseases inc. type-2 diabetes mellitus - part 1, white paper | asthma update 2023 part 2: asthma drug pipeline 2023 & discussion of new drug candidates, white paper | asthma update 2023 part 1: modern asthma management inc. asthma diagnostics & therapy.

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Business Development

Get in touch with our Business Development Team to find out how Charité Research Organisation can deliver optimal value for your early clinical research projects and help you reach Proof of Concept faster.

Studienberatung Patienten und Probanden erreichen uns unter (030) 450 539 210.

Please give us a call / short e-mail

Please feel free to discuss your early clinical trials with us. Your message will be received attentively by our business development team. We come back to you with feedback from our clinicians and project management experts....

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The ClinCompetence Cologne GmbH is a contract research organisation (CRO) located in Germany.

The ClinCompetence Cologne GmbH is a full-service contract research organisation (CRO) specialised in the areas of allergology, infectiology, and ear, nose and throat medicine. Professor Dr. med. Ralph Mösges, former Director of IMSIE (Institute of Medical Statistics, Informatics and Epidemiology), Medical Faculty of the University of Cologne, founded CRI – Ltd. in 2006, a private research institute from which ClinCompetence Cologne GmbH emerged in the autumn of 2018. The company’s shareholders are Prof. Dr. med. Ralph Mösges and Dr. rer. nat. Silke Allekotte.

Our staff members come from the fields of medicine, natural science, statistics, and other relevant disciplines. We have more than 30 years of experience in the areas consulting, planning, implementation, regulatory affairs, project management, medical writing, and publication of phase I–IV clinical trials involving medicinal products but also of investigations with medical devices and of epidemiological and non-interventional studies.

A high-dose, depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy has a favourable efficacy/safety ratio

Quality management, mission – our concept.

• Development and conduct of basic and patient-oriented clinical research in the fields of medicine and medical informatics with the aim of improving patient care
• Main expertise: allergology, infectiology, and ear, nose and throat medicine (ENT)
• Commitment to the continuous improvement of our quality management system with the goal of meeting the needs and expectations of our clients and other stakeholders as well as fulfilling legal and regulatory requirements
• Realisation of our mission by strengthening our interdisciplinary team of highly qualified and dedicated staff through a permanent offering of continuing and advanced training programmes
• Trust and mutual appreciation as the basis for the collegial cooperation within our team

Vision – Our main goals

• To reaffirm our scientific excellence through high-quality publications in leading medical journals and through recognised expert status in our core competencies
• To hold a strong national and international market position as a competent and leading contact for allergology and ENT research as well as medical informatics
• To maintain healthy growth as the basis for the successful implementation and sustainable development of our business model as a specialised full-service contract research organisation

Our Executive Board

Prof. Dr. med. Ralph Mösges

Prof. Dr. med. Ralph Mösges, FAAAAI is an otorhinolaryngologist and allergologist.

Dr. Silke Allekotte

Dr. Silke Allekotte is a biologist and experienced clinical project manager.

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Symposium 2024

The annual Symposium will take place at the Holiday Inn Munich City Centre on  November 22, 2024 .

You will find the program and the title here in June at the latest.

read more »

Federal Association of Contract Research Organisations

The “Bundesverband Medizinischer Auftragsinstitute” (BVMA) was founded in July 1991 in order to represent CROs (Contract Research Organisations) which are based in Germany or German speaking countries. The BVMA is based in Munich.

At present 49 companies, operating in the field of clinical research at a national as well as international level, are members of the Association (status: January 2024). Furthermore there is one honorary member. This means that the member companies with their approximately 8,000 employees represent more than 80% of the employees in the German CRO market.

Advantages of Membership

No entries available.

Guarantee of High Standard

BVMA Members

European CRO Federation

Application for Membership

Bundesverband Medizinischer Auftragsinstitute Federal Association of Contract Research Organisations (BVMA) e.V.

c/o FGK GmbH Heimeranstrasse 35 80339 Munich

Tel. +49 (0)89 - 89 31 19 - 188 bvma(@)bvma.de

Request via mail

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Welcome to CONET

- clinical operations network, - your european partner in clinical research, who we are and what we do:.

Good reasons to choose CONET:

Our expertise is your access to local know-how.

Your data. Our passion.

ClinStat is an independent contract research organization (CRO) located near Cologne as Headquarter with branch offices in Berlin, and Essen (Germany). We act since 2006 as an integrated partner for pharmaceutical companies, hospital facilities, manufacturers of medicinal products as well as health insurance providers and other medically-oriented institutions.

We offer our services in biostatistics, statistical programming, HEOR/market access, data management and medical writing. Our expertise covers inter alia biometrics, psychometrics, epidemiology, health economics, and healthcare research. ClinStat has realized a considerable number of successful studies and we look forward to support your business with our expertise.

We provide services for pre-clinical studies, clinical studies of phases I-IV, post-marketing studies and observational studies in pharmaceutical research. As your experienced partner for epidemiological studies, studies in health services research/public health as well as studies concerning health economics, we are competently supporting our customer’s success. For some pharmaceutical companies, we enjoy pre-determined assignments as preferred CRO.

The cornerstone of success at ClinStat is our highly qualified team, which has a broad scientific background and profound knowledge in clinical research. We work according to the current international quality standards and guidelines and have the competence and capability to integrate the client-specific needs. ClinStat is experienced to perform full services in close cooperation with our pre-selected CRO partner companies or alternatively with CROs appointed by our customers.

We live our values to support our customers’ business.

Our therapeutical experience

As a reliable partner for small/medium size companies and global players, ClinStat employees own 20 years experience in a wider range of therapeutical areas including:

• Allergology
• Cardiovascular diseases
• Consumer healthcare
• Dermatology
• Endocrinology
• Gastroenterology
• Gynecology, women’s health
• Implantology
• Indications with medical devices
• Infectious diseases
• Ophthalmology
• Orthopedics
• Respiratory diseases
• Rheumatology

ClinStat values & commitments

Customer satisfaction.

Our goal is to achieve long-lasting co-operation for mutual benefits of our clients and our employees. Our employees, serving with a scientific background and experience are the keystones for adding high value to our customers goals.

We commit to quality at the highest level to obtain correct and validated results. ClinStat is committed to the integrity of data based on traceable sources.

Professionalism

We contribute to your success, as we bring our expertise and experience in your projects. Our personnel is the heart of our strategic development, therefore we create conditions for the individual men and women of ClinStat to reach their full potential.

Our employees have an academic background and work according to state-of-the-art methodology in clinical research. Regular training is being provided to all employees in internal and external training courses to obtain current and advanced scientific advice.

Transparency

We provide transparent and traceable results according to the national and international guidelines and requirements. We generate our reports in a reproducible and understandable manner. We take responsibility for our work which is based on mutual respect, fairness and honesty.

Our vision is to continue providing state-of-the-art services and to improve continuously our service portfolio clinical research and statistics. Our objective is to develop and maintain sustainable collaboration with our customers as their long-term service partner and CRO.

Our brochure is available for download as pdf file

Brochure German

Brochure English

Sustainability

Our ambition is not only to be commercially successful, but to achieve this success while considering the needs of our employees and society as well as the protection of natural resources.

Important aspects of this approach are

• Integrity in Business transactions, Ethics
• Fairness in competition
• Protection of confidential Information & Intellectual Property Rights
• Creation of reporting possibilities about unlawful behavior
• Fair dealing with employees, Social Responsibility
• Health protection, safety, environmental and quality regulations

ClinStat GmbH Institute for clinical research and statistics

Innungstr. 6 50354 Huerth/Germany

Phone: +49 2233 4602-0

Email: [email protected] Homepage: www.clinstat.eu

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Clinical Research International Ltd.

CRI – Clinical Research International Ltd. is a full-service contract research organisation (CRO) specialised in allergology, otorhinolaryngology as well as infectiology. It was founded in 2006 by Prof. Ralph Mösges in Hamburg, Germany. In 2016, Dr. Silke Allekotte joined CRI’s executive board. Since 2017, more clinical researchers from the University of Cologne were brought on board. CRI now finds its new base in the heart of Cologne city.

We are medical doctors, life scientists, statisticians and other specialists with more than 30 years of experience in clinical study initiation, management, consultation and regulatory affairs.

GCT in Germany

Clinical trials in Germany are approved by the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich Institute, depending on the Investigational Product.

The Federal Institute for Drugs and Medical Devices (BfArM) is the medical device and clinical research regulatory authority in Germany. Functioning as an independent body within the Federal Ministry of Health, the BfArM deals with the authorization of drugs of medical devices based on the German Medicines Act (AMG).

The Paul-Ehrlich Institute is responsible for examining clinical trials of vaccines and biomedicines.

A positive opinion on the study must also be obtained from the responsible ethics committee.

Official links

Pharmaceutical industry & clinical trials market, medical system in germany.

The German healthcare is a dual public-private system. The sector is regulated by the Joint Federal Committee Healthcare ensuring free healthcare for all. In addition, it is possible obtain private health insurance to replace or top up state cover.

Therapeutic areas

Find out what is required for your study in Germany here [email protected]

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Velocity is a leading clinical research site organisation across Europe, with sites in Germany, Poland, and the U.K. Fully integrated operations and a unified technology platform ensure Velocity sites can accelerate site start-up and accurately forecast and enrol patients at scale, saving considerable time for you.

World-class sites, reliable enrollment, and high performance for clinical trials across Europe

Velocity opened its first European site in Hamburg , Germany, in mid-2022, and expanded that same year with a site Leipzig, followed by two more sites in the U.K. with the acquisition of Egin Research. In 2023, Velocity added three greenfield sites in the U.K., six sites in Poland, and four more in Germany (via acquisitions of KO-MED Centra Kliniczne, ClinMedica Research, InterMed, Klinische Forschung Berlin, The Pulmonary Research Institute at the LungenClinic Großhansdorf, and KLB Gesundheitsforschung Lübeck).

The acquisition of KO-MED, Poland’s leading site network, marked Velocity’s entrance into oncology research. The acquisition of The Pulmonary Research Institute in Germany further demonstrated Velocity’s commitment to supporting specialty research programs across Europe and worldwide.

Berlin, Germany • Velocity Clinical Research

Grosshansdorf, germany • velocity clinical research.

Hamburg, Germany • Velocity Clinical Research

Leipzig, Germany • Velocity Clinical Research

Luebeck, germany • velocity clinical research.

Wiesbaden, Germany • Velocity Clinical Research

Biała podlaska, poland • velocity clinical research, lublin, poland • velocity clinical research, puławy, poland • velocity clinical research, skierniewice, poland • velocity clinical research, staszów, poland • velocity clinical research, zamość, poland • velocity clinical research, united kingdom, bristol, united kingdom • velocity clinical research.

North London, United Kingdom • Velocity Clinical Research

High Wycombe, United Kingdom • Velocity Clinical Research

Leicester, united kingdom • velocity clinical research, romford, united kingdom • velocity clinical research.

Therapeutic and Specialty Population Expertise

Experienced Investigators, Specialists, and Research Staff

Therapeutic expertise.

• Allergy/Immunology
• Consumer Health
• Dermatology
• Endocrinology/Metabolic Disorders
• Family Practice
• Gastroenterology
• Infectious Disease
• Internal Medicine
• Medical Devices
• Ophthalmology
• Orthopedics
• Pain Management
• Plastics, Reconstructives
• Pulmonary Disease
• Respiratory
• Rheumatology
• Sleep Medicine
• Smoking Cessation

Specialty populations

• Fetal and Newborn Health
• Healthy Normal Subjects
• Pediatrics, Adolescents
• Women's Health

Specialized trial support

• Biosimilars
• Combination products
• Confinement
• Decentralized
• Diagnostics
• Interventional
• Observational

The right sites. The right investigators. The right partner for your trials.

All Velocity sites feature experienced principal investigators supported by well-trained research staff. Geographic dispersion also supports access to critical subpopulations. Above all, Velocity's sites are built to ensure world-class quality, scalability, and productivity.

Contract research organization in Germany

Interested in becoming a vendor.

REACH OUT TO [email protected] FOR MORE INFORMATION.

Participate in a study

For questions or assistance please email [email protected]

PLEASE CONTACT  HR SUPPORT  FOR ALL CAREER RELATED INQUIRIES.

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PLEASE CLICK  HERE  TO SUBMIT INQUIRY.

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Berlin location

Unter den Linden 21 10117 Berlin, Germany

If you wish to participate in our clinical trials, please call +1 210-635-1515 or  visit here .

Visit  Careers  to view and apply for all open jobs here.

View all Worldwide offices on our  Global Reach  page.

Contract research services in Berlin

Worldwide Clinical Trials employs more than 2,000+ professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way.

From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. 

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CRO for Clinical Trials in Germany

Germany is considered one of the best countries in the EU to run clinical trials (within the top 3 countries in Europe in number of clinical studies). By June 2021, the US clinical trial portal ( clinicaltrials.gov ) had registered a total of 21,470 clinical studies with at least one German site.

Germany has an estimated population of 83 million inhabitants. Clinical trial sponsors running studies in Germany can be sure that they will have top hospitals available to complete their enrollment fast. The largest cities in the country include Berlin, Hamburg, and Munich.

Sofpromed manages clinical trials in Germany as well as in other EU member states if needed. We can provide the full range of CRO services for biotechnology and pharmaceutical companies planning clinical studies in Germany and other European countries.

Our CRO services in Germany include:

• Regulatory authority submissions
• Ethics committee submissions
• Site selection and activation
• Site contracting
• Clinical monitoring
• Data management
• SAS statistical programming
• Biostatistics
• Medical writing
• Clinical supply management
• Drug logistics

In German clinical sites we can provide CRO services in the following therapeutic areas:

• Cardiovascular
• Central nervous system (CNS)
• Dermatology
• Infectious diseases
• Respiratory diseases

[email protected]

How Much Does a Clinical Trial Cost in Germany?

Get Quote Here

What is the Cost of Manufacturing a Drug for a Clinical Trial?

BfArM - Federal Institute for Drugs and Medical Devices

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German Clinical Trials Register

Deutsches Register Klinischer Studien

The German Clinical Trials Register ( DRKS ) is the German WHO primary registry. It is responsible for the registration of all health related studies on humans conducted in Germany. The DRKS now contains over 16,000 studies and around 2,000 studies are added each year. The aim of the registry is to offer the public a complete, up-to-date overview of clinical trials in Germany. The DRKS is not only a source of information for patients. It also supports the expert audience in the planning of clinical trials and thus helps to avoid redundant trials.

Direct Accesses

Drks search tool.

• Login Study Submission
• Create DRKS Account

You can find DRKS studies by using the publicly accessible search tool. The further use of the data is subject to our terms of use.

DRKS Study Submission

Submit your clinical trial here! By registering in the WHO Primary Register for Germany, you fulfil the ICMJE requirements for publication in international medical journals.

FAQ and Glossary

FAQ and glossary provide you detailed information on frequently asked questions. It's worth a visit.

The DRKS is part of a national and international network and cooperates closely with other study registers and institutions.

DRKS Statistics

In this section you will find a wide variety of statistics on the studies included in the DRKS .

Useful Links & Publications

Publications and further information on DRKS and clinical trials provide an overview on the topic.

No answer found in the following documents?

• DRKS online help - public area - DRKS Public Study Search Manual
• DRKS online help - authenticated area - Instruction DRKS application (study administration)
• DRKS online help - authenticated area - tab 1
• DRKS online help - authenticated area - tab 2
• DRKS online help - authenticated area - tab 3
• DRKS online help - authenticated area - tab 4
• DRKS online help - authenticated area - tab 5
• DRKS online help - authenticated area - tab 6

Your DRKS team will be glad to help you:

E-Mail: drks@bfarm.de Phone: +49 (0)228 99307-4942 Web: www.drks.de

Note: When contacting us, we'd like you to refrain from sending personal medical records or similar private documents for reasons of data protection.

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ICON provides full service outsourcing and flexible support for biotech specific needs such as due diligence and asset valuation.

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End-to-end cardiac safety solutions, including ECG, event monitoring, BPM, long-term Holter monitoring, ECHO and MUGA studies.

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Innovative early clinical solutions that will advance your drug development strategy.

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Transforming recruitment through patient-centric trials and real-world, real-time data.

Market Access

Expertise in mission-critical pricing, market access, and reimbursement. 

Navigating the complexity of real-world healthcare data: choosing the right tools at the right time

Watch the webinar.

The future of pharmacovigilance: Exploring automation and AI in literature surveillance

Streamlining IRT in clinical trials: Simplify, optimise, succeed

Icon insights.

• 01 Apr 2024

SDoH data for efficient, patient-centred clinical trials

Insights from PHUSE US Connect 2024

• 27 Mar 2024

Diabesity: Overlapping pathophysiology informs multi-indication treatment

• 25 Mar 2024

Site Training for Clinical Trial Success

• 28 Feb 2024

Beyond awareness: Driving progress on the Rare Disease journey

• 21 Feb 2024

Rare disease trials require effective participation support strategies to succeed

Strategies for de-risking rare disease programmes during research and development

• 13 Feb 2024

Insights from the 2024 ISCR Annual Conference: India’s evolving clinical research arena

• 26 Jan 2024

Ensuring safety and compliance: The essentials of outsourcing pharmacovigilance

What’s happening in icon, how can we help.

• Site & Patient Recruitment
• Medical Device
• Real World Evidence
• Decentralised & hybrid clinical trials
• Digital Disruption

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

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?

• Healthy Volunteers
• Patient Volunteers
• Patient Advocacy Groups

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.

• Management team
• Global reach
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• Meet us at an event
• Jamie Macdonald
• Peyton Howell
• Michael Crowley
• Jonathan Shough
• Sheri McCoy
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• Global Reach
• Our DE&I Strategy
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• Supplier Diversity Policy
• World Vaccine Congress
• Patients as Partners U.S.
• MAPS Americas
• ASCPT 2024 Annual Meeting
• Managing Complexity in Cell and Gene Trials: Establishing an RBQM Strategy that Drives Better Performance
• EDI in clinical research: The case for adaptive strategies at every step
• 17th ISCR ANNUAL CONFERENCE 2024
• IncluDE Site Solutions Summit
• AAN Annual Meeting
• ASGCT Annual Meeting
• Dermatology Drug Development Summit EU
• World Orphan Drug Congress US
• AACR Annual Meeting
• BIO International Convention
• DIA Global Annual Meeting
• International Society for Cell & Gene Therapy
• Final countdown: How to transition your trials under EU-CTR
• SCRS: Oncology Site Solutions Summit
• Accelerating Vaccine Development Through Operational Excellence
• Alzheimer’s Disease vs Multiple Sclerosis Drug Development: Similarities, Differences & New Perspectives

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

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

Tina had lost her father to Crohn's disease. Now she faced her own diagnosis.

Then came the diagnosis. Finding out she had Crohn’s disease, one of two IBD syndromes that affect 10 million people worldwide, wasn’t a surprise considering her family’s history with the disease. But it derailed her life.

Tina was in her early 20s. She lived in New York City and was building a promising future for herself in finance.

She spent the next 10 years trying countless medications and underwent 20 surgeries. nothing worked., then, finally, she enrolled in a clinical trial., within months, she was in remission—and has been ever since., today, she’s a patient advocate, sharing her experiences to help keep our clinical trials focused on the needs of patients like her., lives can change when you design inflammation and immunology trials with agility, precision, and care..

• Keep up with urgent clinical demands
• Utilize the right experts, with deep I&I experience
• Help participants with chronic conditions feel safe and cared for
• Get seamless, end-to-end support across indications.

What we do, we do

Our Experts

Our inflammation and immunology specialists collaborate to get your treatment to patients faster.

MORE EXPERTS

Ayman Farahat

Vice President, Glob...

Bharti Arya

Executive Director, ...

Claire VanEenwyk, M.D.

Michelle Pietzak, M.D.

Global TA Section He...

Andreas Reiff, M.D.

Senior Vice President, Global TA Head, Inflammation & Immunology, Global Medical Services

Drawing from 25+ years of experience as a clinician, investigator, and thought leader, Andreas provides strategic, regulatory, and scientific guidance for your projects in inflammation and immunology. He also assists with protocol development and complex market analyses.

"Tina’s story and the many struggles she went through remind us that there are many patients out there who are waiting for us to push the boundaries of research, trying to find new answers to an old disease and its challenges."

Our I&I team is 13,100+ strong, with experience across indications, to match the needs of your trial.

Our diverse project experiences and expertise in patient recruitment and engagement result in fast, efficient trials.

Clinical trial sites around the world allow us to accelerate study startups.

• North America
• South America
• Middle East & Africa

Innovative trial designs allow us to optimize your trials for maximum impact.

And our patient-first approach results in deeper, more relevant insights for trial design and execution.

BENEFITS MAY INCLUDE

What can we do to help you change patient lives?

See I&I capabilities Visit all therapeutic areas Explore I&I careers

Want our latest insights for inflammation and immunology?

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 Tina.

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.

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The EUCROF Association

Welcome to the website of eucrof.

EUCROF was founded in October 2005.

The aims and objectives of EUCROF were defined as follows:

• Promote clinical research of high quality in Europe in general and in the European Union in particular;
• Form a legal entity to represent the interests of CROs in the EU, for example, in transactions with regulatory bodies, the pharmaceutical-biotechnology industry and the medical research community;
• Promote a close relationship and mutual understanding between the national member associations and the above-mentioned bodies;
• Promote the exchange of information between member associations;
• Develop training and educational programmes for clinical research, and assist the national member associations in setting up such programmes and ensuring their quality;
• Distribute information on developments in clinical research to health professionals;
• Organise international conferences and meetings.

Furthermore, the Federation's objectives include: discussions on selected topics with representatives of the pharmaceutical industry to enhance business relations and identify common concerns, support more productive discussions with European bodies (EMEA/EU Commission), and endeavour to develop transcontinental relationships with other associations e.g. with ACRO (Association of Clinical Research Organisations) in the USA and JCROA (Japanese Clinical Research Organization) in Japan.

The Federation consists of Members from 15 EU countries: Belgium (BeCRO), Czech Republic (ACRO-CZ), France (AFCROs), Germany (BVMA), Greece (HACRO), Italy (AICRO), Lithuania (Lithuanian GCPRA Association), Poland (POLCRO), Romania (ACCSCR), Slovakia (SACROP), Spain (AECIC), Sweden (ASCRO), The Netherlands (ACRON), Turkey (SAKDER) and UK (CCRA). The Federation has also 15 Associate Members in Albania, Bulgaria, Croatia, Denmark, Latvia, Portugal, Slovenia, Spain, Switzerland (4), Ukraine and UK, as well as 6 Partner Members in Algeria, Australia, Egypt, Israel, Mexico, Pakistan and USA. It stands for 450+ Affiliated CROs and represents 31 countries.

Since December 2006, the Federation is managed by an Executive Board (see here below) which holds monthly meetings. Each year, the Federation organizes two General Assemblies(in Spring and Fall) with all its Association Members, Associate Members and Partner Members.

Definition of CRO: “A Contract Research Organisation (also called Clinical Research Organisation, CRO), is a person or an organisation (including commercial, academic and non-profit) that provides services to industry and other stakeholders such as governmental organisations, foundations or hospitals, on a contract basis and within the scope of clinical research (experimental or observational), as well as other activities in connected domains.” 

EUCROF has 13 Working Groups:

• Clinical Trial Centres : this WG was created at the beginning of 2020. The primary objective of the Clinical Trial Centres Working Group is to look for synergies between CROs and Research Sites / Clinical Trial Centres to enforce and guarantee the clinical research in Europe. It is indispensable to ensure that sites are well-prepared and within the Working Group definitions; expectations can be set, which can be of support for both CROs and Clinical Trial Centres. Through the Working Group it is also possible to represent Clinical Trial Centres and be a partner of the dialogue with European Authorities, Associations, the pharmaceutical industry and medical device representative organisations. 
• Clinical Trials Legislation : This group focuses on any proposed changes to Regulations and Guidelines for Clinical Trials - predominantly in the EU, but also elsewhere in the world. This group actively participates public in consultations and prepares comments for feedback to the European Medicines Agency (EMA) and other regulators.
• Clinical Trials Logistics : This group focuses on issues related to Clinical Trials Logistics. The CTLog WG was set up to promote international cooperation and harmonisation of medical clinical trials logistics to ensure the safety, effectiveness, and performance of clinical trials logistics worldwide.
• Communication : This group is focused on the effective and timely communication to EUCROF’s Members and stakeholders of all of the Federation’s initiatives, activities and important news, to facilitate increased awareness and the achievement of its set objectives.
• Early Phase : This group evaluates and compares current practices within the bio-equivalence studies and the Phase I studies in Europe;
• Events & Training : This group establishes educational webinars throughout the year for its members and wider audience to provide training and increased awareness of key topics in clinical research.
• Innovative Medicine : This group is focused on Advanced Therapies Medicinal Products. The goal of this group is to identify, examine and provide solutions to the principal issues identified in ATMPs development and regulation, in constant dialogue and collaboration with the Industry and European Authorities.
• Medical Devices : This group provides a forum for discussion of various aspects of clinical research associated with Medical Devices and IVD. Its further objective is to interact and share experiences with other stakeholders involved in this area.
• New Technologies : this group evaluates current and expected new technologies and evaluates how these can benefit and impact the clinical trial environment.
• Paediatric : this group works closely with authorities, paediatric networks, and associations such as EFGCP, to improve paediatric research. The group collects and analyses information on paediatric research that it shares via trainings, publications, presentations at conferences. The group participates in initiatives set up to improve research in children and to develop better medicines for children.
• Patients' Association : This group fosters actual and confident collaboration with patients in clinical research.
• Pharmacovigilance : This group focuses on management of pharmacovigilance services throughout the product lifecycle which are increasingly undertaken by the CRO sector for the pharma & biotech industry, including current and future best practices, as well as regulations for this critical area.
• Real World Data & Digital Health : This group promotes good practices in the conduct of Late Phase studies in Europe - with particular reference to observational ones - through the sharing of knowledge, competence, expertise and skills, also speaking in congresses/conferences and participating in EMA public consultations. 

EUCROF is a stakeholder of European Regulatory Authorities:

EUCROF has been integrally involved in stakeholder meetings collaborating with the EMA to discuss and support the implementation of the forthcoming EU Clinical Trials Regulation. Since 2014 EUCROF has been able to work with other stakeholders to influence and shape important aspects of the planned implementation, in particular the transparency requirements of the new Regulation some years ago and in more recent years the Clinical Trial Information System. Stakeholder meetings routinely occur 3 to 4 times a year and are either face to face at the EMA’s offices in Amsterdam or via Webex and it is anticipated they will continue until at least the planned implementation of the Regulation.

EUCROF participated from the start of the development of the clinical trial portal and database (now called the Clinical Trial Information System) and was involved in the initial User Acceptance Testing (UAT) of the system. During the initial development, over fifty EUCROF testers were involved in 6 UATs during 2016, 2017 and 2018. However, in 2019 the EMA switched to a new approach progress this important project. This new approach involves an iterative and more agile project delivery model such that the project will develop and deliver functionalities through short-cycled sprints that require planning of the scope, analysis, design, development and delivery. Due to its contributions to date EUCROF was selected to have 2 Product Owners (POs) participate in the important testing activities with POs from other stakeholders’ associations.

A press release from the EMA covering its Management Board meeting in December 2019, which confirmed the Board’s agreement of an updated plan outlining the items that needed to be completed ahead of the audit of the CTIS to commence by December 2020. EUCROF POs are continuing to provide support throughout 2020 ahead of this audit.

In addition, EUCROF interacts with the EMA and contributes to several of its other initiatives. This includes providing comments on EMA Consultation papers and attending meetings and workshops. Our most recent examples are as follows:

• EMA Guidance Consultation

Our Clinical Trial Legislation Working Group, chaired by Dagmar Chase, has collaborated with EFPIA and other organisations to review a document issued by the EMA entitled

Submission of comments on 'Point to consider on implications of Coronavirus diseases (COVID-19) on methodological aspects of ongoing clinical trials' (EMA/158330/2020)

There was a four-week public consultation, until 23 April 2020, after which a consolidated response from all parties was submitted to the EMA. There was a large number of comments submitted, which confirmed the very high level of interest and need for guidance regarding the implications of COVID-19 on methodological aspects of ongoing clinical trials.

In addition, EUCROF’s President, Martine Dehlinger-Kremer, along with input from some members, provided input to EU Commission/EMA for the revision of the Guidance (v3) for sponsors on how to manage clinical trial during the COVID-19 pandemic

Feedback on two key issues identified for temporary regulatory flexibility:

• direct sponsor/distributor to patient IMP transfer
• remote source data verification as to not hinder market access of COVID-19 treatment or life-saving medicines for unmet medical needs. 
• EMA’s Regulatory Science Strategy.

The EMA published its strategy in March 2020. It provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines, that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated, so that we can adapt our process in real-time, where needed.

The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary.

The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.

EUCROF’s President, Dr Martine Dehlinger-Kremer, attended two workshops to discuss and contribute to the draft strategy prior to its publication.

The above confirms how EUCROF has established itself as a well known and highly recognised representative for CROs, giving them a voice in the EU.

Executive Board

• President, Martine DEHLINGER-KREMER (Germany)
• Vice-President, Stefano MARINI (Italy)
• Secretary, Simon LEE (UK)
• Treasurer, Yoani MATSAKIS (France)
• Member, Christophe GOLENVAUX (Belgium)

EUCROF Secretariat

Assia Rosati - EUCROF

Mobile: +39 349 858 6648

EUCROF Address

EUCROF – European CRO Federation

EUCROF secretariaat

p/a LB Finance

Tappersweg 12T

2031 ET, Haarlem

The Netherlands

The Executive Board

Dr martine dehlinger-kremer.

German Federal Association of Contract Research Organisations (BVMA) Germany

Stefano Marini

Vice-President

Associazione Italiana Contract Research Organization (AICRO) Italy

Yoani Matsakis

Association Française des CROs (AFCROs) France

Clinical and Contract Research Association (CCRA) United Kingdom

Christophe Golenvaux

The Belgian Association of CROs (BeCRO) Belgium

Mission Statement

The objective of EUCROF (the European CRO Federation), a non-profit organization founded in 2005, is to promote Clinical Research by improving the knowledge, competence/expertise and skills of Contract/Clinical Research Organisations (CROs) in Europe.

The Federation represents and supports the interests of CROs in Europe towards regulatory bodies, the pharmaceutical, biotech, medical device and other healthcare-related industry within the field of clinical research, as well as the medical and affiliated research community. EUCROF organises and supports training and education programs to increase the quality of clinical research and to improve collaboration and interaction amongst all stakeholders in the field of Clinical Research in Europe. Active participation in international congresses and meetings further underlines the significant role of CROs in Clinical Research in Europe.

Regulatory Authorities recognize EUCROF as the representative for European-based CROs, regularly calling upon EUCROF to contribute to the never-ending debate on the improvement of rules and regulations.

Define your future as a clinical research associate (CRA). Explore opportunities to join our global team of game changers.

Our experts outline five key approaches to ensure pediatric clinical trials are designed to meet the specific, unique needs of children.

Experts share how organizations can prepare to execute their clinical trials under the European Union’s new Clinical Trial Regulation (CTR).

Discover the transformative impact of technology and innovation in clinical trials, along with the regulatory challenges and adaptations that come with it.

PPD is a leading global contract research organization focused on delivering life-changing therapies

Clinical development

Laboratories, ppd careers, connect with us, ppd offers proven solutions, from early development to phase ii-iii to pharmacovigilance to peri- and post-approval services, to ensure your product’s success.

PPD offers a comprehensive set of lab services – from bioanalytical to vaccine sciences.

Offering proven solutions, ranging from early development to pharmacovigilance to post-approval services, to ensure your product’s success.

Clinical trial therapeutic expertise

Learn about our expertise in areas like oncology, cardiovascular, rare diseases and more.

Fuel your drug development more efficiently

Here are four key areas to consider when choosing the right FSP partner for you.

130k+ colleagues globally connected by our mission to enable our customers to make the world healthier, cleaner and safer.

• Our mission
• Early Phase
• Phase II / III CRO Services
• Decentralized Trials
• Biostatistical
• Clinical data management
• Medical writing
• Pharmacovigilance / Drug Safety
• Clinical Trial Operations
• Statistics and programming
• Data Management
• Regulatory Affairs
• Quality Assurance
• Radiopharmaceuticals
• Cell & Gene Therapy
• Rare Diseases
• Real-World Evidence
• Other Specialty Therapeutics
• Join Our Team

Bringing reliability

And expertise to, clinical development.

We are a Clinical Research Organisation with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.

OUR SERVICES MODELS

As a clinical research organization, aixial group collaborates with sponsors to develop oncology, cell & gene, and rare diseases therapies . we provide innovative solutions to overcome the challenges and complexities faced by global biotech and pharma companies. we advise you to choose the best model for your clinical research and development needs..

▶ Full-service partnership

Aixial Group is a well-established, full-service CRO with experienced people and advanced technology for clinical data management.

Commitment to results

▶ Functional service provision

We have extensive experience in governance, management, and partnership as an FSP provider. Our approach is tailored to your requirements and adapts as the partnership evolves.

Service level agreement

▶ Consulting support

We provide the clinical development capabilities and integrated consulting expertise needed to streamline development at every step, in a faster and more cost-effective way.

Commitment of resource

AREAS OF EXPERTISE

Our experience has enabled us to refine and evolve to incorporate the technology, processes, and insights necessary to ensure your clinical trial needs are future proof. our approach gives us the flexibility to meet the ever changing needs of biotech and biopharma companies worldwide..

▶ Radiopharmaceuticals

▶ Rare diseases

▶ Cell and Gene Therapy

▶ Real World Evidence (RWE)

▶ Other Therapeutic Specialty

Our cro solutions, as a clinical research organisation, we specialise in applying both skills and technology to deliver well-managed trials in oncology, cell and gene therapy, and other rare diseases..

▶ Early Phase

▶ Phase II / III CRO Services

▶ Decentralized Trials

▶ Radiopharmaceutical Trials

How can we support your next project?

What is happening in Aixial Group?

Demonstrating product value from multiple endpoints in rare disease trials

Rare diseases are often multifaceted, and a single endpoint is often not sufficient to fully describe treatment

Experts in Radiopharmaceutical Development

Radiopharmaceutical therapy utilizes radioactive atoms to target and precisely treat cancer cells.

Mechanistic evidence by the HTA bodies

At the bottom of the EBM hierarchy, mechanistic evidence is not highly valued by the HTA bodies responsible for…

Indirect treatment comparisons

Lionel RIOU FRANÇA, Chief Scientific Officer, was involved in two analyses involving patients with Late-Onset Pompe…

For a reasoned therapeutic revolution in cell and gene therapy…

Cell and gene therapies are multiplying, and with them the hopes of patients, their families, and healthcare professionals…

Cmed and Larix fully integrate into Aixial Group, the CRO solution of ALTEN GROUP

Cmed and Larix fully integrate into Aixial Group Press release – May 30th 2023 Following its acquisition of Larix in…

Our sponsors testify

I wanted to extend my thanks from a DM perspective to the entire team for the effort and work you have put in throughout the year, to deliver something that is hugely complex and should have a big impact in the future. Although we have been impacted by COVID, you have all managed to keep some positivity and continue to drive forward at each timepoint and for this I am extremely thankful.

Your willingness to work through the problem and find a solution shows the site we’re working hard to provide them with the best possible solutions. This is great news and makes me feel really good about selecting you as our vendor.

I would like to thank you for your hard and smart work, professionalism and that the team always strived to give the best on the project .

Let me underline once more that I’m very grateful to the whole team. I really appreciate how you handled this: fast action, pragmatic decision, efficient solution, going the extra mile to support the study. Top collaboration skills. Not to be taken for granted, thank you!

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Yahoo Finance

Ark clinical research announces advancing accessibility for obesity through innovative research trials on glp-1 drugs.

LONG BEACH, Calif., April 16, 2024 --( BUSINESS WIRE )-- Ark Clinical Research ("Ark") is advancing accessible solutions for obesity and obesity-related diseases through clinical research and a free health clinic, which administers health assessments and manages patient care. Ark is a research organization with sites in Long Beach and Fountain Valley, California. While the clinical research organization conducts Phase I-IV clinical trials in various therapeutic areas, the company is particularly focused on weight loss studies and accessibility of these drugs for those in need, particularly for low-income and minority patients.

More than 100 million Americans are currently faced with the challenge of excess weight or obesity. These statistics are alarming, because obesity is often associated with other serious medical conditions such as Diabetes, High Blood Pressure, High Cholesterol, Cardiovascular and Fatty Liver Disease. Although new medical treatments have given hope for patients who suffer from obesity and obesity-related diseases, this positive impact has been limited, particularly for those in socially disadvantaged communities. Despite approved weight loss treatments playing a crucial role in improved health outcomes, many Americans cannot afford them or get access to them. Inadequate insurance coverage exacerbates the issue by denying individuals coverage, and monthly out-of-pocket expenses for medications can range from $900 to $1300, which is often out-of-budget for patients.

These hurdles can be particularly frustrating especially when these drugs can have very real impact on losing weight and patients’ health. Ark’s Investigators have witnessed patients losing up to 36% of their body mass and shedding 20-85 pounds in under a year. For example, a patient reportedly lost over 85 pounds during the study. Science has shown that there are certain people with genetic predispositions that make it very difficult to lose weight through diet or exercise, and yet patients have difficulty getting access to drugs without paying out of pocket. At Ark, studies with drugs that have a weight-loss component are often of particular interest to patients who are obese or have obesity-related conditions. While these studies are placebo controlled, they can provide another avenue for GLP-1 drugs or other obesity drugs.

Increasingly, the FDA as well as the pharmaceutical industry have recognized the need for diverse patients in clinical research; given Ark’s prime locations in Southern California and diverse leadership, the research organization has been on the forefront of recruiting from diverse patient populations. Over the last year, 72% of Ark’s patients participating in obesity research were minorities. Ark ensures inclusive participation so medical advancements are shared more equitably across people of color, striving for high-quality research that is diverse, affordable, and accessible to all people.

Dr. Kenneth Kim , Founder and Executive Chairman, and Samira Moran , CEO, appreciate the necessity of clinical trials for those who genuinely need access to effective care. As part of Ark’s strategic planning, Ark will employ mobile unit technology by Summer 2024 to further the goal of healthcare for all. The mobile unit will work with local communities and organizations, overcoming the barriers of access to healthcare and research. With the launch of groundbreaking treatments, accessible, affordable, and diverse healthcare is more vital than ever before.

If you are interested in learning more about Ark Clinical Research, please contact Samira Moran, CEO by phone at 310-710-2985 or by email at [email protected] .

View source version on businesswire.com: https://www.businesswire.com/news/home/20240416224873/en/

Ark Clinical Research Samira Moran, CEO 310-710-2985 [email protected]

Qureight uses AI to help speed up drug development. Check out the 11-slide pitch deck it used to raise $8.5 million.

• Cambridge-based startup Qureight raised $8.5 million in an oversubscribed funding round.
• Qureight's platform and AI-driven tools simplify data management for pharma companies.
• Take a look at the 11-slide pitch deck used to secure the funding.

British techbio startup Qureight has secured $8.5 million in an oversubscribed Series A round.

Techbio is a burgeoning sector that uses the application of data and engineering in biotech ; it has gained a lot of traction as AI promises to revolutionize biotech applications, especially in drug discovery and patient care.

Launched in 2018, Qureight wants to simplify how pharma companies deal with the complex datasets often used during clinical trials.

The Cambridge-based startup has built a platform that curates different types of medical data for analysis, which can be used in the drug discovery process — especially for complex lung and heart disease.

It has also created an AI-enabled 3D image modeling platform. "For example, we can start to structure images of lungs using AI," said cofounder and CEO Muhunthan Thillai.

In doing so, pharmaceutical companies can use these extensive data points to analyze their clinical trial outcomes better — and "look for drug responses and find new endpoints," he added. The data can also be used to create virtual patients for clinical trials.

The startup primarily works with pharmaceutical companies, including heavyweights such as AstraZeneca, as well as hospitals and clinical research organizations. It makes its money by charging a licensing fee for its platform and an additional rate for the usage of specific tools.

While the tech market has been sullen since 2022, with layoffs and down rounds being the defining trends of the past year, investor interest in techbio and AI has remained strong.

Still, Thillai said that navigating the round was somewhat difficult. The Series A was led by Hargreave Hale AIM VCT, with participation from XTX Ventures, Guinness Ventures, and existing investors including Playfair Capital, Meltwind, Ascension Life Fund, and Cambridge Angels.

"In the end, it was oversubscribed because of the traction and commercial partnerships we got," Thillai told Business Insider.

With the fresh funds, Qureight aims to invest in the platform and develop various AI-enabled tools. It will also spend more money on data acquisition.

Check out the 11-slide pitch deck used to secure the fresh funding.

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Office of the Vice President for Research

Lab week 2024: celebrating medical laboratory professionals.

April 14 - 20, 2024, is Medical Laboratory Professionals Week, an annual celebration to highlight and show appreciation for laboratory professionals, including those at the State Hygienic Laboratory (SHL) at the University of Iowa.

Lab Week is sponsored by the American Society for Clinical Laboratory Science and coordinated by 17 national clinical laboratory organizations.

“At the State Hygienic Laboratory, our teams have demonstrated again and again that we are prepared to skillfully respond to evolving emerging public health threats, adapting to meet the changing needs of laboratory medicine and the evolution of diagnostic testing,” said Michael Pentella, SHL director.

Established in 1904, the SHL works closely with local, state, and federal partners to fulfill its mission in the Iowa Code to investigate and evaluate any issues that are in the interest of environmental quality and public health in the state. The lab serves all of Iowa’s 99 counties through disease detection, environmental monitoring, and newborn and maternal screening. Today, the SHL also quickly responds to infectious disease threats, including mpox, SARS-CoV-2, whooping cough, and much more.

“Our teams are continually forward-thinking in terms of taking continuing education classes to prepare us for the future challenges of laboratory medicine,” said Pentella. “We are proud of our role to help ensure that Iowa communities are healthy places to live, work, and play.”