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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 |
