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.

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