M S Ramaiah Clinical Research Centre coordinates all Clinical trials ...

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The site has undergone audits by USFDA in 2007 and also by DCGI in 2011 and completed them successfully without any adverse remarks. Many trials have faced Sponsor audits, being the highest or fastest recruiting site and have completed them without any issues. M S Ramaiah Hospital has encouraged and nurtured research activity by providing the necessary Infrastructure and manpower to support their Principal Investigators and their teams in smooth conduct of many complex and long term global trials. The Institution has a Schedule Y compliant, pro-active Ethical Review board and an Institutional Scienti�c Committee, who review and scrutinize every Protocol that is submitted before approving them to be conducted at the site. The ERB also oversees the conduct of each study by asking for regular updates about the progress and the safety issues encountered. The Institution and the center o�ers all CRO’s and Sponsors a large team of quali�ed 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 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.
M.S.R.C.R.C, Their Dedicated Clinical Research Unit Boasts of Large team of well trained , experienced , quali�ed 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
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M S Ramaiah Clinical Research Centre coordinates all Clinical trials ...

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