India has grown into a major hub for conducting Global clinical trials in the past decade and is increasingly being recognized as a quality player and preferred partner. Many reasons have contributed to this :
- Large and diverse patients pool in major therapeutic indications
- Availability of Qualified and skilled manpower
- Excellent infrastructure facilities
- Comparative cost advantage
- Increased awareness of ICH-GCP and regulatory guidelines
A number of audits conducted by International Regulatory authorities like USFDA, EMEA and our own DCGI in the past couple of years have shown that good quality data is being generated from the Indian sites and at the same time the recruitment rate is faster.
Ramaiah Clinical Research Centre coordinates all Clinical trials happening in the Institution .The intention is to manage clinical trials under strict regulatory guidelines and uphold the highest standards of professional excellence, integrity, trust and ethics. It has streamlined all Clinical Research activities in the campus under one roof and acted as a one point contact for all CRO and Sponsors who want to conduct trials in the Institution.
The site has undergone audits by USFDA in 2007 and also by DCGI in 2011 and the Malaysian Regulatory Agency in 2017 completed them successfully without any findings. Many trials have faced Sponsor audits, being the highest or fastest recruiting site and have completed them without any issues.
Ramaiah Clinical Research Centre, their dedicated Clinical Research unit boasts of a
- large team of well trained , experienced , qualified Study coordinators (which includes Medical, Dental, BHMS and BAMS doctors as well as Basic Science graduates and post graduates)
- 5000 Sq. Feet of dedicated area for clinical research.
- Dedicated Space for monitoring and audits.
- Cold storage area to store drugs within required temperature range.
- Deep freezers (-20*C) for storage of samples.
- Separate Area for Patients involved in Clinical trials –for Consent process,physical examination, ECG, blood draw, training etc.,
- Social workers for patient counseling and retention activity.
- Fax, internet, 24/7 power-back up and other facilities.
- Archival facility for study documents.
- NABL accredited local Lab.
- Well-designed Standard Operating procedures.
- In-house training along with regular workshops and interactive discussions to upgrade the existing skill set of the team.
- Increased awareness of ICH-GCP and regulatory guidelines.
The institution has a Schedule Y complaint proactive Ethical review board – which has renewed its registration with the DCGI in 2017 and achieved NABH accreditation in January 2018. It is one among the first few institutions in the country to have got the NABH accreditation.
The Institution and the centre offer all CRO’s and Sponsors a large team of qualified Investigators in all therapeutic areas with a wide-ranging knowledge of entire spectrum of drug development and a strong grasp of current regulatory environment in India, a large database of patients , a state of the art 1200 bedded twin hospitals facility and one of them , the Memorial Hospital being NABH accredited providing tertiary, multi-specialty care in the entire spectrum of medicine, Intensive care unit for adult, pediatric and neonatal patients, NABL accredited lab , dialysis unit which runs 24/7, all investigational facilities…in a word all requirements for completing any clinical trial successfully.