ICRC Weyer
We are a specialized contract research organization (CRO) based in Berlin, Germany. Our portfolio of services includes high quality Biostatistics, Clinical Data Management and Medical Writing, as well as specialist services such as Medical Data Management, Medical Review and Pharmacovigilance & Safety Writing, all based on a foundation of thorough Scientific Consulting.
All services are provided out of our Berlin offices and for all types of clinical trial projects. ICRC-Weyer's dedicated team of highly skilled employees delivers quality results for all trial phases, whether they are conducted globally or locally. Both sponsors and partner CROs benefit from our longstanding team and timely delivery within pre-determined budgets.
As a member of the MEDIS RESEARCH GROUP, we work closely together with select partners to manage entire trial projects by providing full services, including site selection, recruitment, study conduct and monitoring within Europe, the U.S., Russia and parts of Asia.
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| | |
| ICRC Weyer | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 1993 |
| Headquarters | Boelschestrasse 35 D-12587 Berlin, Germany |
| Number of employees | 11-50 employees |
History
In 1993 ICRC-Weyer was founded by Prof. Dr. Geerd Weyer. In the beginning our company only consisted of the departments of Psychometrics and Medical Writing.
In 1993, Prof. Dr. Geerd Weyer and Dr. Ralf Ihle published the German version of Alzheimer’s Disease Assessment Scale (ADAS).
We expanded our company in 1995 with the departments of Biostatistics and Data Management.
In 1997 Prof. Dr. Geerd Weyer’s Alzheimer’s Disease Assessment Scale:Reliability and validity in a multicenter clinical trial was published (with co-authors).
In 2000 We rang in the turn of the millennium with the introduction of a new department. We added Monitoring to our list of services.
In 2005 we expanded our list of services once again by adding Independent Expert Medical Review.
We became a CDISC Gold member in 2009
We expanded our departments by adding Pharmacovigilance and attained our incorporation as ICRC-Weyer GmbH in 2010.
In 2011 we expanded our company once more by offering Safety Writing from then on.
2013 was an exciting year for our company. Together with ACM we founded the MEDIS Research Group with the goal of better meeting our clients’ needs.
services
- Clinical Data Management and Biostatistics
- pharmacovigilance data management
- Medical writing
- Medical Review
- Scientific consulting
- Safety Writing/Pharmacovigilance
Safety Writing & Pharmacovigilance
Safety Writing/Pharmacovigilance has evolved to be a discipline of its own. With the new European GVP legislation both processes and documents become streamlined, which creates a need for professionally compiled and harmonized content. Utilising pooled resources from the Medical Writing and Pharmacovigilance departments, we have specialised in providing quality writing, consulting and editorial support services for the creation and maintenance of Pharmacovigilance documents. Our services cover pharmacovigilance in the pre- and post-marketing settings.
Safety Writing Services:
- Development Safety Update Report (DSUR)
- Periodic Safety Update Report (PSUR)
- Periodic Benefit Risk Evaluation Reports (PBRER)
- Risk Management Plan (RMP)
Pharmacovigilance Services:
- Set-up & maintenance of validated safety databases
- SAE/AE Reporting
- Expedited Reporting
- Monthly Line Listings
- Medical Safety Reviews
Use of VigilanceOne (eDrug Safety Database):
- Was developed in cooperation with the German regulatory authorities Paul-Ehrlich-Institut (PEI) and Bundesinstitut für Arzneimittel and Medizinprodukte (BfArM)
- Compliant with ICH-E2B and requirements of regulatory authorities (e.g. BfArM/PEI/EMA)
- Supports the E2B data exchange via the Eudravigilance gateway or other E2B compliant gateway interfaces
- Offers exchange formats that guarantee efficient data exchange between VigilanceOne and external receivers and regulatory authorities
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