Introduction & Vision :
The Department of Clinical Trial Services is concerned with the practical application of high-quality clinical research into innovative and effective cancer therapies and prevention strategies. The clinical research wing was established in 1995. Running clinical trials, of whatever size and complexity, requires efficient management, GCRI�s Department of Clinical Trial Services is a one-window operation from study start-up to close-out
Development and management of contracts � including clinical trial agreements with funding agencies, study sponsors, contract research organizations, internal and external site investigators
Preparation and submission of ethics applications � plus amendments and annual reports
Conducting site initiation meetings and visits with stakeholders and study teams
Preparation and maintenance of trial master, site and pharmacy files
Regular safety and data monitoring along with protocol compliance as per local and international guidelines
Financial oversight to ensure compliance with financial agreements and monitoring expenses
Liaison with investigators, regulators and sponsors to ensure timely submission of reports and invoices
Management of study close-out processes
Archiving of documentation for 15 years or as per study/sponsor requirements
Clinical & Academic Activities :
More than 75 International and 25 National/GCS trails have been conducted. The entire faculty is GCP trained. The Department works to ensure that opportunities for collaborative research are maximized and that research is rapidly and efficiently translated into cutting-edge clinical treatment for cancer patients.
The department conducts regular training for its staff on Good Clinical Practice (GCP) workshop, Regulatory Guidelines, etc.