Clinical Trial Management

Our clinical operations teams have a great deal of expertise conducting multicentric international clinical studies across a range of therapeutic specialties. Our staff is made up of seasoned clinical managers, CRAs, physicians, and chemists with a strong background in medicine and extensive understanding of ICH GCP rules and clinical trial laws.

Throughout the trial and site management process, we aim to be attentive, adaptable, and responsive. We also look for creative ways to boost subject recruitment and retention, site productivity, and the timely completion of clinical trials.

Pre-study activities	Study initiation phase	Study conduct phase	Study closeout phase
Study feasibility Site qualification /Investigator selection Execute and oversee Vendor agreements Execute and oversee Investigator agreements Patient recruitment & retention plans	Facilitating investigator meeting GCP training to site staff IEC/IRB submission and approvals CTRI registration Protocol training Safety management training Preparation and implementation of study specific monitoring plans Conduct of study initiation visits (SIV) Perform First patient first visit (FPFV)	Risk based monitoring/Central monitoring Manage adverse event reporting and document protocol deviations/violations Site coordination, Clinical trial supplies and management Oversee Site performance and compliance Source data verification (SDV ) and quality checks at sites Site readiness for Audits & Regulatory Inspections	Perform Last patient last visit (LPLV) IP accountability Notification to IRB/IEC Document archival Site closeout Database lock & archive