Clinical Trial
Management
Precision-driven execution for international multi-centric studies. We bridge the gap between complex clinical protocols and successful regulatory outcomes through integrated management and data integrity.
Multi-Centric Execution
Protocol Optimization
Translating complex scientific goals into executable trial designs.
International Coordination
Seamless management of multi-site operations across borders.
Regulatory Bridge
Ensuring all clinical data aligns with stringent global standards.
Global Operations, Medical Excellence
Our clinical operations teams deliver deep-rooted expertise in conducting multicentric international studies. Composed of seasoned managers, CRAs, and physicians, we operate at the intersection of medicine and rigorous compliance.
"We focus on creative strategies to boost subject recruitment and retention, ensuring site productivity meets the most demanding timelines."
Trial Lifecycle Management
A systematic, phased approach to ensuring clinical data integrity and participant safety from feasibility to closeout.
Phase 01: Pre-Study Activities
- Study Feasibility & Qualification
- Investigator Selection & Selection
- Vendor & Contract Oversight
- Recruitment Plan Strategy
Phase 02: Study Initiation
- Investigator Meetings & Training
- IEC/IRB & CTRI Submissions
- Monitoring Plan Implementation
- Conduct of Initiation Visits (SIV)
Phase 03: Study Conduct
- First Patient First Visit (FPFV)
- Risk Based & Central Monitoring
- Adverse Event (AE) Reporting
- Source Data Verification (SDV)
Phase 04: Study Closeout
- Last Patient Last Visit (LPLV)
- IP Accountability & IRB Notification
- Database Lock & Data Archival
- Final Site Closeout Procedures