New Delhi: Welcoming the move, Naz Haji, SVP and India CRO Head, Quintiles, mentioned “We are very pleased to see the positive decisions announced by the DCGI on 2 August, 2016 with respect to the restrictions that were earlier imposed on the number of clinical trials an investigator could undertake at any point in time and on the minimum requirement of 50 beds for trial sites.” He further opined that these developments are indicative of the regulators’ responsiveness to concerns of stakeholders and will give sponsors the choice of the best and most appropriate sites and investigators for a study. “More importantly, they are also reflective of the regulators’ commitment to creating a more rational and scientific framework for ensuring patient safety and efficacy in clinical trials, while still enabling sponsors to drive innovation,” commented Mr Haji.
“Over the 19 years we have been in India, Quintiles has worked and continues to work closely with regulators and other stakeholders to ensure a robust environment for clinical research in the country. We work with an unwavering commitment to patients, safety and ethics and putting patients first is at the heart of everything we do. The DCGI’s announcements will allow us to work with sites and investigators who are driven by the same commitment and patient-centric approach,” he added further.