Ethics Committee

Committee composition

Committee meetings

Protocol Review

Monitoring

Clinical Trials Department Set Up

Infrastructure Planning

Staffing and Training

Standard Operating Procedures (SOPs)

Quality Accreditation – NABH, ISO, WHO-GMP

Regulatory Affairs

Regulatory Compliance

Regulatory Submissions

Audits

Safety Reporting

Conducting Clinical Trials

Trial Design and Implementation

Protocol verification

Informed Consent Process

Trial execution and visit planning