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Clinical Trial Services
 
Academic Staff
Dr. Shashank J. Pandya
Chairman, Director
Dr. Harsha P. Panchal
In Charge, Professor
Mr. Rakesh N. Nayi
Social Worker
Dr. Bhadresh M. Shastri
Clinical Research Assistant
Contact Details
Department of Clinical Trial Services

Direct :
079-22688000 ; 079-22690000


 

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

Key services

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 :

There are More than 150 International and National/GCS trails have been conducted and more than 1500 patients have been treated. The entire faculty and clinical research staff is ICH-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.

GCP WORKSHOPS:

Year
Sponsor
Venue
Sep 2009
Eli Lilly & Company
Nalanda Hotel, Ahmedabad
Dec 2012
Novartis Ltd.
GCRI, Ahmedabad
June 2014
Novartis Ltd.
GCRI, Ahmedabad
Sep 2015
Lambda Therapeutic Research Ltd.
GCRI, Ahmedabad
Jan 2021
Lambda Therapeutic Research Ltd.
GCRI, Ahmedabad


OPD Information

NABH Certified

Ethics Committee Accredited for NABH

ISO 15189:2012
@ The Gujarat Cancer & Research Institute, All Rights Reserved.