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Clinical Trial Management

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Helping Sponsors to Conduct Global Clinical Trials with Uncompromised Quality and Compliance

Techsol has been helping sponsors to conduct and complete multi-centric global clinical trials across various therapeutic areas like Infectious Diseases, Oncology, Cardiology, Gastroenterology, Nephrology, Diabetes, Obstetrics & Gynecology, Urology, Dermatology, Ophthalmology, Neurology, and Parental nutrition. With our domain expertise, we have a well-established clinical operations team for managing the conduct of pre-clinical studies to post-marketing surveillance.

We offer full-range services starting from protocol design, Paper CRF/EDC data management, statistical analysis, study report writing, preparation, tracking and maintenance of study documentation (Study Protocol, Investigator’s Brochure, Site Documentation, Principal Investigator Documentation,  IRB/EC and other Regulatory documents, Site contracts, Study Case Report Forms, Informed consent forms, Trial supplies and Drug Accountability log, Operational reports, etc.)

Clinical Operations

Activities We Manage for Clinical Operations

  • Complete Study feasibility assessment
  • Perform Site qualification and Investigator selection
  • Evaluate, execute and track Vendor agreements
  • Coordinate, execute, review and maintain Principal Investigator agreements
  • Strategize and create subject recruitment and retention plans
  • Facilitating investigator meeting
  • Providing ICH-GCP training to site personnel
  • Coordinating and tracking IEC/IRB submission and approvals
  • Completing CTRI registration
  • Delivering Protocol training and Safety management training
  • Preparation and implementation of  study specific monitoring plans
  • Conducting study  initiation visits (SIV)
  • Tracking all subject accruals starting from 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
  • Update and maintain electronic Trial Master File (eTMF)
  • Complete Last Patient Last Visit (LPLV)
  • Track IP Accountability
  • Notify IRB/IEC on Trial Progress and Completion
  • Archive all Study Documents
  • Perform Site Closeout
  • Database Lock & Archival

Our clinical operations teams includes highly qualified and experienced Clinical Managers, CRAs, Medics, and Pharmacologists to meet and exceed quality and compliance requirements as per various 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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