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

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M S <strong>Ramaiah</strong> <strong>Clinical</strong> <strong>Research</strong><br />

<strong>Centre</strong> <strong>coordinates</strong> <strong>all</strong> <strong>Clinical</strong><br />

<strong>trials</strong> happening in the Institu-<br />

tion with the intention of<br />

managing clinical <strong>trials</strong> under<br />

strict regulatory guidelines and<br />

upholding the highest standards<br />

of professional excellence,<br />

integrity,trust and ethics.It has<br />

streamlined <strong>all</strong> <strong>Clinical</strong> <strong>Research</strong><br />

activities in the campus under<br />

one roof and acted as a one<br />

point contact for <strong>all</strong> CRO and<br />

Sponsors who want to also<br />

conduct <strong>trials</strong> in the Institution.


The site has undergone audits by USFDA in 2007 and also by DCGI in<br />

2011 and completed them successfully without any adverse remarks.<br />

Many <strong>trials</strong> have faced Sponsor audits, being the highest or fastest<br />

recruiting site and have completed them without any issues.<br />

M S <strong>Ramaiah</strong> Hospital has encouraged and nurtured research activity<br />

by providing the necessary Infrastructure and manpower to support<br />

their Principal Investigators and their teams in smooth conduct of<br />

many complex and long term global <strong>trials</strong>.<br />

The Institution has a Schedule Y compliant, pro-active Ethical Review<br />

board and an Institutional Scienti�c Committee, who review and scrutinize<br />

every Protocol that is submitted before approving them to be<br />

conducted at the site. The ERB also oversees the conduct of each study by<br />

asking for regular updates about the progress and the safety issues<br />

encountered.<br />

The Institution and the center o�ers <strong>all</strong> CRO’s and Sponsors a large<br />

team of quali�ed Investigators in <strong>all</strong> therapeutic areas with a<br />

wide-ranging knowledge of entire spectrum of drug development<br />

and a strong grasp of current regulatory environment in India, a large<br />

database of patients , a state of the art 1200 bedded twin hospitals<br />

facility providing tertiary, multi-specialty care in the entire spectrum<br />

of medicine, Intensive care unit for adult, pediatric and neonatal<br />

patients, NABL accredited lab , dialysis unit which runs 24/7, <strong>all</strong><br />

investigational facilities…in a word <strong>all</strong> requirements for completing<br />

any clinical trial successfully.


M.S.R.C.R.C, Their Dedicated <strong>Clinical</strong> <strong>Research</strong> Unit Boasts of<br />

Large team of well trained , experienced , quali�ed Study coordinators<br />

(which includes Medical, Dental, BHMS and BAMS doctors as well as<br />

Basic Science graduates and post graduates)<br />

5000 Sq. Feet of dedicated area for clinical research<br />

Dedicated Space for monitoring and audits<br />

Cold storage area to store drugs within required temperature range<br />

Deep freezers (-20*C) for storage of samples.<br />

Separate Area for Patients involved in <strong>Clinical</strong> <strong>trials</strong> –for Consent process,<br />

physical examination, ECG, blood draw, training etc.,<br />

Social workers for patient counseling and retention activity.<br />

Fax, internet, 24/7 power-back up and other facilities.<br />

Archival facility for study documents.<br />

NABL accredited local Lab<br />

Well-designed Standard Operating procedures<br />

In-house training along with regular workshops and interactive<br />

discussions to upgrade the existing skill set of the team.<br />

Increased awareness of ICH-GCP and regulatory guidelines


MS <strong>Ramaiah</strong> <strong>Clinical</strong> <strong>Research</strong> <strong>Centre</strong><br />

A cent er o f e x cellenc e<br />

Contact:<br />

Head of Operations<br />

Email: info@msrcrc.com<br />

Phone: 080-23601923<br />

Location:<br />

M S <strong>Ramaiah</strong> Advanced Learning Center,<br />

Gnanagangothri, New BEL Road, MSRIT Post,<br />

Mathikere, Bangalore - 560 054.<br />

Visit us at: www.msralc.org

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