Clinical Trial Management

Our clinical operations teams have extensive experience in conduct of multicentric global clinical trials in various therapeutic areas. Our team consists of experienced Clinical Managers, CRAs, Medics, Pharmacologists with excellent medical background and in-depth knowledge on clinical trial regulations and ICH GCP guidelines.

We strive to be responsive, flexible and mindful throughout the trial and site management process; looking for innovative ways to improve subject recruitment and retention, site productivity and 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