Clinical Trial Management Services
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.
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Details
Pre-study activities
- Study feasibility
- Site qualification /Investigator selection
- Execute and oversee Vendor agreements
- Execute and oversee Investigator agreements
- Patient recruitment & retention plans
Study initiation phase
- 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)
Study conduct phase
- 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
Study closeout phase
- Perform Last patient last visit (LPLV)
- IP accountability
- Notification to IRB/IEC
- Document archival
- Site closeout
- Database lock & archive
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