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Drug Development Requires Flexibility In Clinical Trial Design: Interview With ICRC-Weyer Clinical CRO

09-11-2012 03:04 PM CET | Health & Medicine

Press release from: ICRC-Weyer GmbH

Prof. Dr. Geerd Weyer

Prof. Dr. Geerd Weyer

In a recent interview, Prof Dr. Geerd Weyer of ICRC-Weyer GmbH, a Berlin-based clinical contract research organization, claims that every clinical trial is unique and must be designed and treated as such.

What would accelerate drug development and delivery/time to market?

In the last few years, many large pharmaceutical companies have been contracting out clinical development services to single, globally acting service providers. They tend to believe that the globalization of drug development gives them strength and allows them to avoid friction in processes that they would have if they had multiple interfaces and vendors. They believe that this will help them save time and effort, but I consider this to be a one-sided view. Using the services of a niche or specialist provider could help them accelerate clinical development.

Would this limit innovation in any way?

When it comes to innovation, a service provider that can be flexible should be preferred. Smaller organizations are able to bring in study-specific solutions, while larger organizations can bring in productivity and efficiency as they are able to streamline and standardize services. There is a dichotomy between efficiency and productivity on the one side, and innovation on the other. However, standardization does not always work. Processes must be adapted to each study. Clinical development is a process where innovation and flexibility are needed, at least as much as standardization.

What is unique about your approach and philosophy?

We are well aware of the dichotomy I mentioned before, but our philosophy has always been one of cooperation and partnership with clients and other service providers; bringing together our own strengths as a flexible specialist with the strengths of other providers. Our philosophy is also reflected in the way we integrate services across departments. Likewise, our data systems are optimized to seamlessly integrate data from various sources, internal or external.

What is key to clinical research and trial success?

The key is to have the right data in high quality when needed. This can be achieved by recognizing the value that a specialist provider in that respective area can bring, and by not totally relying on standard solutions. There is no single way for succeeding in clinical development. Every trial is unique and must be designed and treated as such.

The interview was held by the Marcus Evans Group, organizer of the Evolution Summit meeting for the life sciences industry. ICRC-Weyer GmbH is a sponsor company at this year’s event.

About Prof Dr. Geerd Weyer:

Prof Dr. rer. nat. Geerd Weyer has held several research chairs at Goethe University Frankfurt am Main, University of Bayreuth, University of Freiburg, and Humboldt University of Berlin. He is an acclaimed author and co-author of numerous scientific publications and guidelines such as ‘International Scales For Psychiatry’ and ‘Alzheimer’s Disease Assessment Scale (ADAS)’.

ICRC-Weyer is an established all phase contract research organization (CRO) based in Berlin, Germany. The company was founded in 1993 by Prof. Dr. Geerd Weyer and offers services ranging from pre-clinical through to phase IV clinical trials. ICRC-Weyer provides complete turnkey solutions including data management, monitoring and medical review services for all stages of the clinical development process.

ICRC-Weyer is involved in several global clinical trials and – through collaboration with strong partners – has established a position at the forefront of the latest developments in the world of clinical research. ICRC-Weyer can support clinical projects at any stage from initial trial inception through to regulatory submission.

The experienced team of ICRC-Weyer has substantial expertise in the various divisions of clinical research, which enables the company to offer services from preclinical to phase I-IV, health claim and post-marketing studies for pharmaceutical, biotech and nutrition companies.

ICRC-Weyer provides services either separately or as synergistic multi-service packages. These Services include Biostatistics, Clinical/Medical Data Management, Independent Expert Medical Review, Medical Writing, Clinical Monitoring, Pharmacovigilance, Regulatory Services, Scientific Consulting and Study Conduct in cooperation with a Phase I and II Unit.

ICRC-Weyer has special expertise in Nutrition, CDISC Data Standards and Medical Review.

ICRC-Weyer GmbH
Boelschestrasse 2
12587 Berlin
Germany

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