G. Kuppuswamy Naidu Memorial Hospital
GKNM Hospital & Consortium, have partnered for Clinical Research Site Management Services at the hospital.
The management and execution of a clinical study protocol at a particular site (facility/clinic/hospital, etc.) is known as Site Management. The typical activities involved in a site management are as follows:
- Designing SOPs for the Institution for Clinical Research
- Updating of the SOPs
- Organizing Sponsor visits
- Negotiating budgets
- Bidding new studies
- Pooling in patients as per each protocol
- Assisting investigators to collate patients for a protocol
- Following up on clinical study patient visits
- Maintaining source documents as per clinical research norms
- Completing Case record forms
- Resolving queries of Data management
- Drafting Serious Adverse Event Reports
- Coordinating with Ethics Committees
- Communicating with Stake-holders
- Cooperating with Sponsors during their routine monitoring visits
- Handling queries of Sponsors
- Organizing for Sponsor Audits
- Coordinating for Regulatory Inspections
- Collating patient data of each visit of a particular study
- Providing status updates to Sponsors
- Maintaining drug accountability
- Ensuring adherence to the Regulatory norms of Clinical Research