Clinical Trials Operations

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Clinical Trials Operations

Cispact promises expertise in complex clinical trials by optimizing trial designs, properly planning and conducting operations, ensuring patient safety and maintaining data quality throughout. Our team of diligent and highly skilled professionals drive project management, patient recruitment & retention and site management/engagement to further facilitate your clinical trials. We also constantly achieve efficiency, streamline activities, imbibe flexibility and take responsibility to leverage solutions that best fit your goals of clinical development.

Site Engagement, Management & Monitoring Services

  • Feasibility, Site Selection, and PI Selection Support
  • Site qualification, initiation, budget & contract negotiations
  • Ongoing site monitoring & management (Routinely executed)
  • Regulatory document collection, review & management
  • Management/facilitation of IRB/EC submissions & remote monitoring via EDC
  • 100% Targeted or Risk Based monitoring
  • Electronic Trial Master File management (eTMF)
  • Clinical Trial Vendor Management
  • Pre-populated regulatory documents packages
  • Site Tool Kits & best practices shared among sites
  • Regularised check-in and support from in-house specialistst
  • Site training on ongoing procedures and the frequently asked questions
  • Proper counselling, recruitment & follow-ups for patients
  • Protocol compliance, deviation & violation management
  • Maintenance of supplies, inventories and documents
  • Inspection, audits & reports throughout the trialt

Project Management Services

  • Detailed Project Management Plans around risks, training, assessment, etc.
  • Clinical Study Contracts & Budgets with monthly forecasting
  • Project ownership & management of SOW and Project Timelines
  • Risk identification, assessment, mitigation and contingency
  • Direct engagement with IRBs and competent authorities on behalf of Sponsor
  • End-to-end Clinical Trial Site, Database & Patient Management
  • In-house, On-site Monitoring, quality control and maintenance of study documents
  • Inspection, audits & closures of trials as per guidelines
  • Oversight and support of site personnel on procedures & regulatory guidelines
  • Highly optimised clinical research associates training programme

" We are constantly innovating and bridging the gap between study sites and sponsors to ultimately deliver best-suited services for a successful clinical trial. "