Better Bonding Between U.S., Indian Regulators Can Ensure Good Quality Of Data From India's Clinical Trial Sites, Say Experts
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Select Indian clinical research organizations have called for greater collaboration between drug regulators in India and the U.S. to increase confidence about the quality and reliability of clinical trial data being increasingly generated at scores of Indian sites
You may also be interested in...
Patient Safety First: Indian Regulator Takes Steps To Tighten Grip Over Site Inspections, Ensure Data Credibility
MUMBAI - As India moves rapidly to become an integral part of large-scale global clinical trials, the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare has declared a set of new guidelines to ensure adequate safety of trial participants
Patient Safety First: Indian Regulator Takes Steps To Tighten Grip Over Site Inspections, Ensure Data Credibility
MUMBAI - As India moves rapidly to become an integral part of large-scale global clinical trials, the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare has declared a set of new guidelines to ensure adequate safety of trial participants
Data Integrity A Key Concern In Foreign Trials
As more and more clinical trials are done outside the U.S., sponsors must be careful to ensure that sites are in compliance with FDA data integrity rules as well as ethical criteria, Barbara Gotthelf, a partner at McCarter & English, said in a Sept. 22 webinar sponsored by Medmarc.