clinical research organization berlin

• Publikationen
• Informationen über klinische Forschung und eine Übersicht über aktuelle klinische Studien finden Sie auf unserem Studienportal: CRO-Studienportal

Studienteilnehmer

Herzlich willkommen in der Zukunft früher klinischer Entwicklung.

• Infrastruktur

Gelebte Wissenschaft inmitten der Kompetenzzentren der Charité.

• Erstanwendung im Menschen
• Proof of Concept
• Neue Biologika
• Biosimilars
• Small Molecules
• Medizinprodukte und Gesundheitstechnologie
• Nahrungsergänzungs- und Nahrungsmittel
• Allergologie
• Atemwegserkrankungen
• Augenheilkunde
• Dermatologie
• Endokrinologie
• Gastroenterologie
• Gynäkologie
• Hämotologie und Onkologie
• Immunologie und Regenerative Medizin
• Infektionserkrankungen
• Inflammation
• Kardiovaskuläre Erkrankungen
• Nahrungsmittel
• Niereninsuffizienz
• Psychiatrie und Psychosomatik
• Rheumatologie
• Schlafmedizin
• Schmerzforschung
• Stoffwechselerkrankungen

Erstklassige klinische Studiendurchführung und studienindividuelle Projektleistungen.

• Klinische Studiendurchführung
• Wissenschaftliche und regulatorische Beratung
• Prüfplanentwicklung
• Einreichungen bei Zulassungsbehörden und der Ethik-Kommission
• Routinelabor
• Projektmanagement
• Datenmanagement
• Biostatistik
• Medical Writing

Erfolgreiche Rekrutierung von gesunden Freiwilligen und Patientenpopulationen.

• Patientenrekrutierung
• Rekrutierung gesunder Probanden

Unübertroffenes Preis-Leistungs-Verhältnis auf verschiedenen Ebenen.

• Fallstudien
• Unternehmen
• Operative Umsetzung
• Rekrutierung

Die Charité Research Organisation ist der ideale Partner, um das ganze Potential Ihres translationalen Entwicklungsprogramms zu entfalten

Die Charité Research Organisation führt Ihre Studien im Umfeld eigener Expertise und externer Koryphäen durch

Die Charité Research Organisation begleitet den Sponsor von der Konzeption bis hin zur Durchführung der Studie und darüber hinaus

Die Charité Research Organisation macht das Unmögliche möglich: Frühe klinische Studien in nur einem Zentrum - von gesunden Probanden bis zu seltenen Patienten

Die Charité Research Organisation verfolgt stets das Ziel, die Erwartungen des Sponsors durch hohe Qualität sowie Kosten- und Zeitersparnisse zu übertreffen 

Die Charité Research Organisation ist ein Auftragsforschungsinstitut mit einem klaren Fokus auf der möglichst schnellen und effizienten Überführung Ihrer Entwicklungsprogramme von der Erstanwendung im Menschen hin zum Proof of Concept. In Kooperation mit der Charité - Universitätsmedizin Berlin führt die CRO klinische Studien der frühen Phasen in Berlin im Herzen Europas durch. Mehr erfahren

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White Paper | Therapeutic Concepts for Obesity and Related Diseases inc. HFpEF - Part 3

White paper | therapeutic concepts for obesity and related diseases inc. nafld/nash - part 2, white paper | therapeutic concepts for obesity and related diseases inc. type-2 diabetes mellitus - part 1.

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Business Development

Unter folgender Rufnummer für Firmenkontakte erreichen Sie unser Business Development Team, das Ihnen in einem persönlichen Gespräch gern aufzeigt, wie Ihr Projekt der frühen klinischen Forschung vom Erfolgsmodell der Charité Research Organisation profitieren kann.

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

CRS´ Highly Specialized Clinical Pharmacology Unit (CPU)

CRS Berlin is housed in the top floor of an appealing building located in the heart of Berlin. Owing to the complex floor plan and an intelligent access control system in-house and outpatient clinical trial activities can be spatially separated, allowing the simultaneous conduct of several studies without interference.

Accordingly, the CRS Berlin unit has 18 intensive monitoring beds available, each equipped with a computerized ECG device, systems for continuous blood oxygen saturation (SpO2) measurement and vital signs monitoring, plus eight convenient rooms, each with two beds. Furthermore, CRS Berlin comprises several examination rooms, a gynecological unit with two examination chairs, state-of-the-art ultrasound equipment, as well as various laboratories for cardiometabolic assessments and immediate blood and urine processing.

CRS Berlin and its Outstanding Expertise

A major scope of the CRS Berlin unit is the conduct of early phase clinical trials in the area of women’s health, including postmenopausal women. This especially covers first-in-human (FiH) and long-term outpatient studies with challenging pharmacokinetic (PK) / pharmacodynamic (PD) designs including a broad spectrum of medicine administration routes (oral, dermal, subcutaneous, intravenous, intravaginal, intrauterine). It also covers early phase clinical trials with special populations such as women with endometriosis or polycystic ovary syndrome (PCOS).

A plurality of established as well as experimental gynecological methods are applied by board certified gynecologist at our site, e.g., standard gynecological examinations, transvaginal ultrasound, vaginal cytology, endometrial biopsy, Insler and Hoogland scores – these are just some examples illustrating the techniques in command of CRS Berlin.

Outpatient studies with women of childbearing potential can be conducted either cycle-dependent or with a synchronizing cycle intervention preceding the treatment phase, which is leading to more grouped treatment schedules. 

Moreover, the CRS Berlin unit has accumulated significant expertise regarding the implementation of clinical trials in all common trial designs, e.g., human pharmacological trials with contrast agents and specialized therapeutics and trials in cardiometabolic indications such as obesity, insulin resistance, diabetes, and cardiovascular disease.

Thus, CRS Berlin can realize a wide range of study types supported by a database with a large diversity of volunteer populations.

CRS Berlin can realize a Wide Range of Study Types

The team of the CRS Berlin unit is highly competent in planning and conducting clinical research in vulnerable people and complex conditions. Key terms for what is meant are:

• Healthy volunteers
• Women‘s health
• Men‘s health
• Elderly subjects
• Early clinical research phase I and II – first-in-human (FiH)
• Long-term outpatient studies
• Trials with challenging pharmacokinetic (PK) / pharmacodynamic (PD) designs
• Trials employing different medicine administration routes (oral, dermal, subcutaneous, intravenous, intravaginal, intrauterine)
• Trials applying established and experimental gynecological methods (e.g., standard gynecological examinations, transvaginal ultrasound, vaginal cytology, endometrial biopsy, Insler and Hoogland scores)
• Human pharmacological trials with contrast agents  and specialized therapeutics
• Trials in cardiometabolic indications such as obesity, insulin resistance, diabetes, and cardiovascular disease.

The Medical Director of CRS Berlin, Dr Sybille Baumann, also CRS Board Member, is certified in clinical pharmacology and anesthesiology. She is an experienced clinician and clinical pharmacologist with more than 25 years of extensive experience in over 250 clinical trials as principal or co-investigator. A highly dedicated team of   qualified clinic employees contributes to the successful conduct of trials.

CRS Berlin – Neighbor of “Campus Charité” and “Virchow Klinikum”

CRS Berlin is located in the heart of Berlin, within walking distance of the “Campus Charité Mitte”, the “Virchow Klinikum”, and the central train station – easily accessible by trial participants and customers from Berlin and elsewhere. Berlin, the largest city in Germany with over 3.5 million inhabitants, is a hotspot for clinical research and life sciences.

The CRS Berlin unit has a separate entrance, an automatic access control system, and an independent technical infrastructure. All this guarantees for a strict segregation from the neighborhood – a precondition for investigating confidence in our exclusive work and sensitive data.

18 intensive care daybeds and 8 convenient double rooms are avaliable.

20 intensive monitoring beds and 6 convinient double rooms are available.

Infrastructure & Location

CRS-Berlin is housed in the top floor of an appealing building on the brink of the Bayer site in Berlin. A separate entrance, an automatic access control system and an independent technical infrastructure guarantees for a strict segregation from the circumjacent Bayer facilities.

Owing to the complex floor plan and an intelligent access control system in-house and outpatient clinical trial activities can be spatially separated allowing the simultaneous conduct of several studies without interference. 18 intensive care beds, each equipped with an ECG, SpO2 and vital signs monitoring system, a computerized ECG device and an EDC system, as well as 6 convenient double rooms are available for this purpose. Furthermore, CRS-Berlin comprises several examination rooms, a gynecological unit with two examination chairs as well as various laboratories for immediate blood and urine processing.

Network of Expertise

Owing to the specialised layout of CRS-Berlin, in-house and outpatient clinical trial activities can be spatially separated allowing several studies to be run simultaneously without cross-interference. This CPU contains 18 intensive care beds, each equipped with an ECG, SpO2 and vital signs monitoring system, a computerised ECG device, as well as 8 convenient double rooms (i.e. 16 beds). CRS-Berlin also comprises several examination rooms, a gynaecological unit with two examination chairs, state-of-the-art ultrasound equipment and various laboratories for immediate blood and urine processing. On-site gynaecological examinations, including Isler- and Hoogland scoring, endometrial biopsies and transvaginal ultrasounds (TVUS), are just a few selected examples illustrating the benefits of working with CRS-Berlin.

CRS-Berlin has gained outstanding expertise in women’s healthcare.

• Healthy Volunteers
• Women‘s Health
• Men‘s Health
• Early Research Unit in Berlin

Conducting studies involving women with childbearing potential and post-menopausal women, this specifically covers FIM and long-term outpatient studies with challenging PK/PD designs including a wide spectrum of administration routes (oral, dermal, subcutaneous, intravenous, intravaginal and intrauterine) and early clinical trials with special populations such as tubal ligated women.

CRS-Berlin also has significant expertise in implementing human pharmacological trials with cardiovascular drugs, contrast agents and specialised therapeutics in all common designs. CRS-Berlin can therefore undertake a wide range of study types supported by a database containing diverse volunteer populations.

Dr Sybille Baumann, a board member certified in clinical pharmacology and anaesthesiology, is the medical director of CRS-Berlin. Dr. Baumann is an experienced Clinician and Clinical Pharmacologist with more than 25 years’ extensive experience in over 350 clinical drug studies as co- and principal investigator. A highly dedicated team of 30 qualified clinic employees and 15 Freelancers contributes to the successful conduct of trials.

Chief Medical Officer

• [email protected]
• +49 621 150 45 – 0

Chief Commerical Officer

• [email protected]

CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability.

Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019.

Based on the CSR rating by EcoVadis in 2022 CRS has been granted Silver Recognition Level.

• Early phase
• Patient Trials
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• Über Studien
• An Studien teilnehmen
• www.probandeninfo.de

Copyright © 2023 CRS. Experts. Early Phase. All rights reserved.

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Berlin, Germany

Velocity clinical research germany gmbh.

Founded in 2002 as Klinische Forschung Berlin GbR and acquired by Velocity Clinical Research in 2023, the experienced team at Velocity’s dedicated research site in Berlin conducts clinical trials across a broad variety of indications. The site has three investigators who specialize in internal medicine and cardiology.

Our Berlin team is committed to being a resource for study volunteers, to providing the highest quality of patient care with compassion and kindness and to advancing medicine through research. With decades of research experience shared among our investigators in Berlin, Velocity will deliver the right patients, investigators, and research staff for your next research program.

Velocity Clinical Research Germany GmbH Ansbacher Straße 17-19, 10787, Berlin, Germany

Phone: +49 30 20859400

Find a Clinical Trial in Berlin Browse current research studies in Berlin on VelocityClinicalTrials.eu .

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 Berlin

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 Berlin is dedicated to conducting quality research in a professional and caring environment.

Dr. Isabelle Schenkenberger

Principal Investigator, Medical Director Isabelle Schenkenberger, MD, has been an Internal Medicine Specialist since 2000, and has practiced at her own clinic since 2002. She studied human medicine at both the Albert-Ludwigs-University of Freiburg and the Free University of Berlin. After graduating, she worked at the Auguste-Viktoria-Klinikum in internal medicine with a focus on cardiology, angiology, diabetology and emergency medicine from 1990 to 2004. Dr. Schenkenberger has also served as a Principal Investigator since 1999.

Katrein Dreykluft

Site Manager Katrein Dreykluft is a state-certified nurse since 1990, after graduating from the University Hospital Charité. She also studied business administration at the Free University of Berlin, going on to work as a freelancer in health care at KPMG, and as a lecturer in health care and IT. Katrein later began her own clinical research site, Klinische Forschung Berlin GbR in 2002, which was acquired by Velocity in 2023.

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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Berlin, Germany

Velocity clinical research germany gmbh.

Founded in 2002 as Klinische Forschung Berlin GbR and acquired by Velocity Clinical Research in 2023, the experienced team at Velocity’s dedicated research site in Berlin conducts clinical trials across a broad variety of indications. The site has three investigators who specialize in internal medicine and cardiology.

Our Berlin team is committed to being a resource for study volunteers, to providing the highest quality of patient care with compassion and kindness and to advancing medicine through research. With decades of research experience shared among our investigators in Berlin, Velocity will deliver the right patients, investigators, and research staff for your next research program.

Velocity Clinical Research Germany GmbH Ansbacher Straße 17-19, 10787, Berlin, Germany

Phone: +49 30 20859400

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 Berlin

The Velocity Berlin 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.

Dr. Isabelle Schenkenberger

Principal Investigator, Medical Director Isabelle Schenkenberger, MD, has been an Internal Medicine Specialist since 2000, and has practiced at her own clinic since 2002. She studied human medicine at both the Albert-Ludwigs-University of Freiburg and the Free University of Berlin. After graduating, she worked at the Auguste-Viktoria-Klinikum in internal medicine with a focus on cardiology, angiology, diabetology and emergency medicine from 1990 to 2004. Dr. Schenkenberger has also served as a Principal Investigator since 1999.

Katrein Dreykluft

Site Manager Katrein Dreykluft is a state-certified nurse since 1990, after graduating from the University Hospital Charité. She also studied business administration at the Free University of Berlin, going on to work as a freelancer in health care at KPMG, and as a lecturer in health care and IT. Katrein later began her own clinical research site, Klinische Forschung Berlin GbR in 2002, which was acquired by Velocity in 2023.

Berlin facility features

The Velocity Clinical Research Germany GmbH 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 • Facilities for extended-stay pharmacokinetic studies • Parking • Nursing station • Secure monitoring rooms or workstations with phone & high-speed internet access • Multiple individual & secure workstations for research staff • Regulatory document processing area • Electronic data capture (EDC) capabilities • Secure record storage • CLIA certified research laboratory or clinical laboratory with CLIA waiver • 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 and Holter machines, digital and analog scales

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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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 ORGANIZATION

Built on digital efficiency, market access has never been easier, mastertrial certified training, digital solutions, tech- enabled acceleration..

Meditrial is a leading Clinical Research Organization (CRO) dedicated to Clinical Trials, Medical Education, Regulatory Affairs and Market Access.

Meditrial drives acceleration with leading edge technology and digital assets to reach milestones with simplicity, speed and efficiency.

SOLUTIONS & TECHNOLOGY

EXECUTION EXCELLENCE AND MEDICAL EXPERTISE

Speed-to-market is paramount for companies looking to breakthrough and address unmet market needs. Meditrial combines medical expertise, execution discipline, and an intuitive digital platform to ensure patients remain engaged, workload is minimized, and data quality is guaranteed.

Read more …

GLOBAL REGULATORY

THE RIGHT PATH THE RIGHT WAY

Innovators seeking market access for life changing therapies require a trusted partner to successfully navigate the dynamic regulatory environment. Meditrial’s unique insights into the global regulations make us a clear choice for organizations who desire the right outcome.

POST-MARKET SERVICES

In an age of growing regulatory, manufacturing and distribution complexity, the need for efficiency is critical. Meditrial simplifies quality and compliance by promoting a quality management system that is fit for your needs and scales as your business grows.

REIMBURSEMENT & MARKET ACCESS

Our mission is to help you deliver life changing medicines to market with efficiency and speed. Regardless of where you are in your medicinal product development journey, we can support you at every stage to provide comprehensive services tailored to your needs.

Intuitive and user-friendly, Catchtrial EDC is a powerful system designed for doctors and patients. Catchtrial provided leading edge customized tools for modern decentralized trials.

Meditrial helps pharmaceutical clients develop future focused business strategies and to implement the time critical programmes and procedures essential to success within worldwide regulatory frameworks.

Read more…

MEDICAL DEVICES

Meditrial is a leading, full services Clinical Research Organization (CRO) focused on the needs of the medical device industry. We are proud to serve the most innovative medtech companies in the world.

Meditrial culture and operating structure are purposely designed to accommodate efficient partnering, important for emerging biotechs all while delivering necessary results to investors, stakeholders and regulatory authorities.

DIGITAL HEALTH

Meditrial provides a complete array of services for Digital Health and Digital Therapeutics with expert analytics, advanced technologies and dedicated programs.

THE NEW WAY TO MASTER EVOLVING REGULATIONS

Our intuitive e-learning platform enables quick and effective knowledge acquisition that can be tailored to any academic medical institution, enterprise, or professional seeking continuous education, learning and training.

CAPTURE & ANALYIZE DATA SIMPLY AND SECURELY

Our cloud-based data management system that provides control of your study from start-to-finish. Utilize our instant All in one CRF, Data Validator, Report Builder, Core Lab images and Safety Adjudicator to capture clinical data with ease.

APP INTEGRATION

SAY GOODBYE TO PAPER SURVEYS

Our ePRO and eCOA apps solution optimize real-time data collection directly from patients by offering a simple and intuitive interface, providing advanced assessments to enhance the patient and doctor experience and improve data quality.

E-LEARNING PLATFORM BY MEDITRIAL

MORE SCIENCE, MORE LEARNING, MORE NETWORKING!

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Find international job offers and send us your application to be part of Meditrial’s team.

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Locations / Contact

Headquarter

FGK Clinical Research GmbH Heimeranstrasse 35 80339 Munich, Germany + 49 (0) 89 893 119-0 + 49 (0) 89 893 119-20 www.fgk-cro.com info @ fgk-cro . com

Martin Krauss, M.Sc. in Statistics + 49 (0) 89 893 119-25 + 49 (0) 173-581 4683 martin.krauss @ fgk-cro . com

Edgar J. Fenzl, M.D. Ph.D. + 49 (0) 89 893 119-22 + 49 (0) 172-673 8556 edgar.fenzl @ fgk-cro . com

Branch Office Berlin

The Berlin office supports the operative units at the German headquarters in Munich by strengthening the range of clinical development services. The core expertise of the highly qualified lead/staff/employees in Berlin lies in project and site management, monitoring and quality management of phase II-IV clinical trials.

FGK Clinical Research GmbH Friedrichstraße 95 10117 Berlin Germany www.fgk-cro.com info @ fgk-cro . com

Hermine Wenzlaff Prof. Dr. +49 (0) 30 235 9183 – 10 +49 (0) 175 194 07 26 hermine.wenzlaff @ fgk-cro . com

Czech Republic

FGK Clinical Research s.r.o. is a contract research organization and provides a wide range of services in drug and medical device development. The core competences of FGK Clinical Research s.r.o. are regulatory affairs, project management and monitoring of phase II-IV trials in the Czech Republic and Slovakia.

FGK Clinical Research s.r.o. Polská 1283/18 120 00 Prague 2 Czech Republic info @ fgk-cro . cz

FGK Clinical Research sp. z o.o. is a contract research organization specializing in providing high-quality expertise in local regulatory affairs, project management and monitoring in Poland. FGK Clinical Research sp. z o.o. is a significant addition to the European FGK Clinical Research group, allowing the company to enhance the range of clinical development services for national and international clinical studies.

FGK Clinical Research sp. z o.o. Hoża 55 m.45 00-681 Warsaw Poland info @ fgk-cro . pl

FGK Clinical Research Kft. is a contract research organization specializing in providing high-quality expertise in local regulatory affairs, project management and monitoring in Hungary. FGK Clinical Research Kft. is a significant addition to the European FGK network, allowing the company to enhance the range of clinical development services for national and international clinical studies.

FGK Clinical Research Kft. Tölgyfa u. 14 1027 Budapest Hungary info @ fgk-cro . hu

United Kingdom

Clinicology Ltd. became an FGK company in February 2024 and covers the UK with offices in Guildford, UK. The company provides high quality clinical trial services and has outstanding expertise in local regulatory affairs and trial conduct.

Clinicology – an FGK company Surrey Technology Centre 40 Occam Road Surrey Research Park Guildford GU2 7YG UK info @ fgk-cro . com

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Top 15 Contract Research Organizations (CROs) in 2024

Post-pandemic, as drug development businesses recover and grow, CROs around the world continue to undergo profound transformation. As in previous years, 2023 will be all about mergers and acquisitions, with big players getting even bigger and smaller companies surviving thanks to niche advantages such as technological know-how or brilliant scientists among their employees.

The top 15 CROs globally would be in the following order based on 2023 revenue :

• LabCorp (Covance) , with 15.05 billion USD (2023) and 75000 employees ( Labcorp , 2024).  In February 2015, Labcorp completes its $6 billion purchase of Covance, Inc., creating the world’s leading health care diagnostics company. The combination of Covance’s drug development leadership and Labcorp’s medical testing expertise builds the market leader in central laboratory and bioanalysis services. Labcorp’s clinical trials companies, Labcorp Clinical Trials and Tandem Laboratories, align under the Covance brand.  
• IQVIA , with 14.85 billion USD  (2023) and 86000 employees (IQVIA, 2022). IQVIA, formerly Quintiles and IMS Health, Inc., is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research.  IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.  
• ICON (PRA) , with 7.74 billion USD (2022) and 41160 employees (ICON, 2023). From a small team of 5 people in 1990, ICON now employs over 41,100 people.  ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile  industry awards .  
• Thermo Fisher Scientific (PPD) , with 7.02 billion USD (2023) and 35000 employees (Businesswire, 2023). Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.  
• Lonza - 6.5 billion USD,   17896 employees. Though being a contract development and manufacturing organization (CDMO), rather than a CRO, takes the 10th position with the 5.9 billion USD in sales and over 17500 employees worldwide (2023), offering “proprietary line of in silico and in vitro services for manufacturability, immunogenicity, potency assessment, humanization and protein engineering” ( https://pharma.lonza.com , 2022). Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 17,500 full-time employees, it comprises high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The business benefits from global supply chains, but we have worked to maintain the agility to address marketplace needs on a local level. CDMOs become reliable partners for Pharma companies as their “services reduce R&D costs while improving productivity and are essential to providing safe and effective treatment to patients” ( https://pharma.lonza.com , 2022.  
• Wuxi AppTec with 5.8 billion USD revenue in 2021 and 44360 employees (Companiesmarketcap, 2022). As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."  

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.  

Cell and Gene Therapy CDMO Solutions has supported the development of 11 FDA approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Unsurpassed end-to-end offering results in enhanced access to scientific and regulatory expertise via multidisciplinary bench of experts to help you problem solve.   

Parexel (EQT Private Equity and Goldman Sachs Asset Management) with 3.8 billion USD in 2022 and 21000 employees (Parexel, 2023). Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. 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, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.  

• Medpace Holdings, Inc. with 1.135 billion USD revenue in 2021 and 5400 employees (Medpace, 2023). Integrating core clinical trial services delivers efficient and streamlined execution and higher quality results. Through its wholly-owned subsidiaries, Medpace offers clinical pharmacology, as well as supporting laboratory services including central labs, bioanalytical lab, ECG core lab, and imaging core labs.  

Worldwide Clinical Trials – 0.6 billion USD , 3000 employees, 60 countries.

Worldwide Clinical Trials started out more than 30 years ago as a small science team with a big goal: To always provide authentic, personalized attention to our partners. And as the industry has grown, CROs have merged, and trials have grown increasingly complex, we haven’t forgotten what truly matters: People.

With more than 3,000 employees in more than 60 countries around the world, we’re still staying true to those roots. Our team is dedicated to staying accessible, flexible, and solution-focused to ensure our partners not only have the best possible outcomes – but they also know their Worldwide team is only a call away.  

Allucent (CATO SMS and Pharm-Olam) – 0.36 billion USD, 1200+ employees .

Allucent originated with CATO SMS, itself created by the merger of Cato Research and SMS-oncology in 2019. Cato Research, founded in 1988, was known for its ability to design and execute successful development strategies and guide creative new products through the regulatory process.

Previous acquisitions by CATO SMS included Array Biostatistics, a full-service biostatistical and statistical programming CRO, and Nuventra Pharma Sciences, one of the industry’s leading providers of clinical pharmacology science and services. With these acquisitions, CATO SMS expanded its services to offer biostatistical consulting, analysis, programming, and cutting-edge modeling and simulation techniques to inform clinical trial designs and predict trial outcomes.

In early 2022, CATO SMS merged with Pharm-Olam, a global clinical research organization delivering clinical trial services to organizations around the world.  

KCR – 0.15 billion USD, 700 employees  

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations.

Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting, and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland.

Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people.  

Advanced Clinical – 0.1 billion USD , 1100+ employees

Today, Advanced Clinical has grown organically, with coverage across North America, Eastern Europe, Western Europe and Asia-Pacific, providing contract research organization (CRO), FSP and strategic resourcing solutions. A research services and strategic resourcing organization committed to providing a better clinical experience by delivering comprehensive Contract Research Organization (CRO), Functional Service Provider (FSP) and Strategic Resourcing services that optimize effectiveness for both patients and sponsors throughout the clinical research journey.

Using our decades of experience, we strive to improve the lives of everyone touched by clinical research and help our clients achieve better outcomes through candid conversations, foresight, resilience and innovative solutions.  

CTI Clinical Trial and Consulting Services – 0.08 billion USD, 750 employees . CTI has grown consistently and significantly, becoming a global organization with associates in more than 60 countries across the world. We have worked on more than 10,000 projects, worked on every continent except Antarctica, and have contributed to more than 150 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Currently, we work with approximately 250 pharmaceutical and emerging biotechnology and medical device companies.

Among recent reasons for mergers and the whole new approach to conducting clinical research, apart from pursuit of new clients, talents, expertise, products, and markets, there have been notorious coronavirus crisis and military conflicts worldwide. We faced the advent of globalization, decentralization, remote monitoring, and personalized approach to drugs R&D. But we are now looking into the era of technology in clinical research. Processes that allow remote audits and monitoring, previously considered too risky, are now risk mitigators (Bahls, Christine, 2021), at least from that point of view. Clinical trial participants enrollment, and even participation itself, constantly moves into tech dimension.

Only few among the leading CROs escaped M&As for now, but this seems to be the matter of time. Savlovschi – Wicks, Theodora (2022) estimated that “in 2021, the global CRO market is expected to reach an impressive US$88 billion by 2028”. According to IQVIA , only in biopharma sector the total transaction value grew by 70% to reach 152 billion USD by the end of 2023, featuring prominent $43Bn Pfizer-Seagen deal, and other considerable M&As for BMS-Karuna ($14Bn), Merck-Prometheus ($10.2Bn), AbbVie-Immunogen ($10.1Bn), AbbVie-Cerevel ($8.7Bn), Biogen-Reata ($7.3Bn) and Roche-Telavant ($7.1Bn).

Among the CRO businesses the following M&As took place lately:

• Charles River Labs acquires  MPI Research (2018), Citoxlab (2019), HemaCare (2020) and Cognate BioServices (2021)
• IQVIA (formerly Quintiles and IMS Health) acquired Clintec and 40% of Q2 Solutions (2021)
• ICON purchased PRA Health Services (2021)
• Thermo Fisher Scientific bought PPD (2021)
• Labcorp purchased Covance and Chiltern
• Inotiv acquired Envigo (2021)
• INC Research and inVentiv Health merged to later become Syneos Health
• Parexel become the property of EQT Private Equity and Goldman Sachs Asset Management
• CATO SMS and Pharm-Olam merged in 2022
• Triley Bidco acquired Clinigen (2022)

The article by Nataliia Vietchinkina, MS in Clinical Research Administration

University of Liverpool. 

References:

• Christine Bahls (2021) ‘The Post-Pandemic CRO Landscape’, Applied Clinical Trials, Applied Clinical Trials-09-01-2021, Volume 30, Issue 9 [online] Available from: https://www.appliedclinicaltrialsonline.com/view/the-post-pandemic-cro-landscape
• Savlovschi – Wicks, Theodora (2022) ‘Top 10 CROs to watch in 2022’ [online]. Available from: https://www.proclinical.com/blogs/2022-3/top-10-cros-to-watch-in-2022
• Labcorp (2022) Labcorp Announces 2021 Fourth Quarter and Full-Year Results, 10 February 2022 [online]. Available from” https://ir.labcorp.com/news-releases/news-release-details/labcorp-announces-2021-fourth-quarter-and-full-year-results#:~:text=Revenue%20was%20%2416.12%20billion%20%2C%20an,by%20divestitures%20of%20(0.1%25)
• IQVIA (2022) IQVIA Reports Fourth-Quarter and Full-Year 2021 Results; Raises Full-Year 2022 Profit Guidance, 15 February 2022 [online]. Available from: https://ir.iqvia.com/press-releases/press-release-details/2022/IQVIA-Reports-Fourth-Quarter-and-Full-Year-2021-Results-Raises-Full-Year-2022-Profit-Guidance/default.aspx#:~:text=Revenue%20of%20%2413%2C874%20million%20for,12.4%20percent%20at%20constant%20currency
• ICON (2022) ICON Reports Fourth Quarter and Full Year 2021 Results, 2022 [online]. Available from: https://www.iconplc.com/news-events/press-releases/icon-reports-fourth-quarter-and-full-year-2021-results/
• Businesswire (2021) ‘PPD Reports Fourth Quarter and Full Year 2020 Results’, 23 February 2021 [online]. Available from: https://www.businesswire.com/news/home/20210223006094/en/PPD-Reports-Fourth-Quarter-and-Full-Year-2020-Results
• Macrotrends (2022) ‘Syneos Health Revenue 2012-2021 | SYNH’ [online]. Available from: https://www.macrotrends.net/stocks/charts/SYNH/syneos-health/revenue
• https://companiesmarketcap.com/ (2022) ‘Revenue for Charles River Laboratories (CRL)’ [online]. Available from: https://companiesmarketcap.com/charles-river-laboratories/revenue/
• Vinluan, Frank (2021) ‘CRO Parexel changes private equity hands again, this time for $8.5B’ [online]. Available from: https://medcitynews.com/2021/07/cro-parexel-changes-private-equity-hands-again-this-time-for-8-5b/
• Medpace (2021) ‘Medpace Holdings, Inc. Reports Third Quarter 2021 Results’ [online]. Available from: https://investor.medpace.com/news-releases/news-release-details/medpace-holdings-inc-reports-third-quarter-2021-results#:~:text=The%20Company%20forecasts%202021%20revenue,%24176.0%20million%20to%20%24180.0%20million%20 .
• Companiesmarketcap (2022) ‘Revenue for WuXi AppTec (2359.HK) Revenue in 2021 (TTM)’ [online]. Available from: https://companiesmarketcap.com/wuxi-apptec/revenue/
• https://pharma.lonza.com (2022) ‘Design, assess and optimize for clinical success’ [online]. Available from: https://pharma.lonza.com/offerings/early-development-services .

Clinical Research News

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• Harvard Pilgrim Health Care Stanford University Not yet recruiting Eco-labels on Restaurant Menus Dietary Habits | Food Preferences | Healthy Diet | Food Selection | Nutrition United States
• The University of New South Wales Evolution Health Pty Ltd Not yet recruiting LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema) Allergy | Eczema Australia
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• Cairo University Not yet recruiting Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy Analgesic Efficacy | Nephrectomy | Open | Subcostal Transversus Abdominis Plane Block | External Oblique Intercostal Block Egypt
• Riphah International University Recruiting Effect of Low-Volume HIT vs. MIC Exercise in Individuals With Increased BMI Overweight and Obesity Pakistan
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Studienzentrum Berlin

Das CRS-Studienzentrum Berlin ist spezialisiert auf klinische Studien, bei welchen Medikamente und Therapien zu gynäkologischen Krankheitsbildern im Mittelpunkt stehen.

Bei uns werden Sie von hochqualifiziertem Personal betreut. Regelmäßige Fortbildungen garantieren stets den neuesten medizinischen Stand. Detailliert informieren wir Sie während Ihrer Studienteilnahme über jeden Schritt und stehen Ihnen bei Rückfragen zur Verfügung. Auf Wunsch erhalten Sie Ihre Untersuchungsergebnisse und können diese mit Ihrem Hausarzt besprechen.

In angenehmer Atmosphäre erwarten Sie im CRS-Studienzentrum Berlin vielfältige Freizeitangebote, unter anderem:

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Gern können Sie Ihr Notebook, Tablet oder Smartphone mitbringen.

Die Teilnehmer werden – je nach Design und Ablauf der Studie – in Einzel- oder Mehrbettzimmern untergebracht. Die Raumbelegung erfolgt nach dem Zufallsprinzip.

CRS Clinical Research Services Berlin GmbH

Siemensdamm 65 13627 Berlin Tel.: 0800 - 724 1362 (kostenfrei) Email: [email protected]

"Wir freuen uns auf Sie; nach einer ganz individuellen Begrüßung durch unser kompetentes und freundliches Personal, das stets ein "offenes Ohr" für Sie hat, werden Sie umsichtig in die Studie eingeführt."

E. Obendorf, Studienassistent bei der CRS in Berlin

Die Übernachtung in hellen, modernen Zweibettzimmern mit allem Komfort sorgt für ein angenehmes Ambiente beim stationären Studienteil.

Unsere große Dachterrasse bietet einen wunderbaren Blick über die Skyline von Berlin und ermöglicht eine angenehme Rückzugsmöglichkeit im Freien.

Willkommen bei der CRS in Berlin!

"In unserem hochmodernen, ansprechenden Studienzentrum in Berlin arbeiten wir nach höchsten medizinischen und wissenschaftlichen Standards. Sie werden bei uns rund um die Uhr betreut und können während Ihres Aufenthalts ein attraktives Ambiente mit zahlreichen Unterhaltungsmöglichkeiten genießen. Wir möchten, dass es Ihnen an nichts fehlt, denn schließlich sind Sie ein wichtiger Teil des medizinischen Fortschritts, weil Sie durch Ihre Bereitschaft zur Studienteilnahme vielen Patienten zu mehr Lebensqualität verhelfen." Dr. S. Baumann,Klinikleiterin CRS-Berlin

>> Aktuelle Studien in Berlin finden Sie hier!

Kontaktaufnahme auch möglich über: Tel.: 0800 - 724 1362 (kostenfrei) Email: [email protected] Vielen Dank im Voraus für Ihr Interesse und Ihre Unterstützung!

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Clinical trials are research studies involving human participants, which are conducted in order to test new medicines or to evaluate innovative treatments or diagnostic procedures. Clinical trials are subject to strict legal requirements and are conducted in accordance with internationally accepted ethical and scientific standards. At every stage of the process, the rights, safety, and wellbeing of trial participants all remain of paramount importance.

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While running a triathlon, andrea stumbled and realized something was wrong..

Her condition worsened. Within months, she was forced to walk with a cane.

Then, finally, came the diagnosis.

She thought it was just an injury. Her hamstrings were tight, and her body felt stiff and slow.

She had als, a condition affecting more than 200,000 people around the world., her life expectancy was shortened to just two to five years — but she was determined to make the most of it., andrea continued to join triathlons, even as she underwent treatment in a clinical trial, inspiring many and raising $1,000,000 for als research., today, alive beyond her original prognosis, she serves on our patient advisory council, using her experiences to help improve our neuroscience trials., lives can change when you design neuroscience trials with speed and precision..

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Antal János, M.D., M.B.A.

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Karla Kanis, M.D.

Mohit Verma, M.D.

Global TA Section He...

Andreas Lysandropoulos, M.D., Ph.D.

Senior Vice President, Global Neuroscience Therapeutic Area Head

With 15+ years of experience as a clinical neurologist, principal investigator, and medical leader, Andreas works with you to create an effective development strategy. Once the plan is in place, he and his team lead all aspects of execution — ensuring your assets are approved quickly and efficiently.

"For me, ‘With Heart’ means with passion and empathy. It is my mission to gather people around a common cause and inspire everybody to reflect on and be passionate about what we do together because it matters to patients who rely on us all for a better life."

Our diverse neuroscience experiences ensure you get the expertise you need across all indications of neurology and psychiatry.

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Sara's only symptom was fatigue. But after some routine tests, she was diagnosed with breast cancer.

When Austin was 3 years old, his parents realized something was wrong. Multiple falls, concussions, and a broken arm led to a diagnosis.

Tina had lost her father to Crohn's disease. Now she faced her own diagnosis — and it derailed her life.

One night, while watching TV with her husband, Robyn felt a lump in her neck. As a doctor, she knew the risk.

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

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.