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Slide 1: Clinical Laboratories Contributing To Clinical Trials Clinical laboratory testing has an essential role to play in detection, diagnosis, treatment and follow up of diseases. The professionals involved in the clinical laboratory are from medical and para medical fields. With the advent of Clinical trials and research in India, it is recognized that clinical laboratories should have systems and procedures in compliance with good clinical laboratory practice guidelines (GCLP). GCLP provides the framework for a quality system for analysis of clinical trial samples, ensuring GCP compliance of processes and results. The analysis of samples collected from patients and healthy volunteers participating in clinical studies forms a key part of the clinical trials process, providing important data which is used to make decisions on an investigational medicinal product’s safety, efficacy and mechanism of action. This data may also contribute to the initiation of new drug development and research projects. Consequently, it is essential that laboratory analysis is performed to an acceptable standard which will ensure patient safety is not compromised and that data are unbiased, accurate and complete. Global harmonization of clinical laboratories for the analysis of specimens from clinical trials operations (i.e., for safety, diagnostic, endpoint laboratory assays) faces international challenges (e.g., laboratory logistical and technical factors), and it is subject to different interpretations of regulations and guidance materials published by the government, accrediting, and non-accrediting organizations Presently CROs in India have clinical laboratories that form the foundation for numerous studies and other research activities. They are fully equipped with state-of-the-art infrastructure, immaculate logistics & experienced, well-trained and competent personnel, assisted by new age technology that comprises the use of Laboratory Information Management System for online information sharing. This assures shorter turnaround time, excellent consistency level and quality of reports. CROs in India have their central laboratories that help in conducting numerous investigations in various branches of laboratory medicine ex: Hematology, Biochemistry, Serology, Urine Analysis and with capabilities for specialised tests required for Phase i studies. Click here for more on biometrics