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Central Clinical Laboratories and Sponsors - A Special Relationship?

Why do Central Laboratory Services belong among the Most Important
Clinical Services?

 

CROs are widely used by pharmaceutical and biotech companies conducting clinical research. Many CROs offer a wide range of services from bio-analytical, data management, clinical monitoring, statistics, electronic data capture and electronic patient diaries to central clinical laboratory services. Central laboratory services are generally outsourced by sponsors despite the fact that most clinical trial programmes have central laboratories involvement. The largest fraction of data collected in clinical trials is usually the data generated in and provided by central laboratories (up to 70 per cent). The primary and most important use of this data is to assess patient safety which represents a tremendous analytical and logistical challenge for both sponsors and central laboratories: transfer of data in the format requested by sponsors (or CROs) to aggressive timelines and the highest possible quality standards.

How did Sponsors and Central Clinical Laboratories Interact in the Past?

Many approaches towards central laboratory management evolved from experience made in the last 10 years, dominated by more tactical approaches up until the mid 90s when a rather recent trend to enter into more strategic partnerships developed. In the following we briefly outline some common approaches of central laboratory management. Common Approaches to Central Clinical Laboratory Management


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By Dr Thomas Hengelage, Clinical Outsourcing Manager at Pfizer Global Pharmaceuticals, and Martin Clark, Sourcing Manager/Clinical Laboratory Specialist at Pfizer Global Research and Development

Dr Thomas Hengelage is Clinical Outsourcing Manager at Pfizer Global Pharmaceuticals based in Freiburg, Germany, and is responsible for contracting with CROs and central laboratories. Having joined Parke-Davis in 1997 as a Contract Administrator, he became Outsourcing Manager at Pfizer in 2000. He studied Biology at the Universities of Bochum, Munich and Freiburg, where he received his doctoral degree in Biology in 1997.

Martin Clark is a Sourcing Manager/Clinical Laboratory Specialist at Pfizer Global Research and Development based in Sandwich, UK, and is primarily responsible for the relationship and contract management of central laboratories and CROs. During the 18 years he has been at Pfizer he has held a number of positions, but has held his present position since 2000. He gained his degree in Chemistry from Robert Gordon's Institute of Technology in Aberdeen in 1981.


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Dr Thomas Hengelage
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Martin Clark
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