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

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