Clinical Operations

  • Designing protocol, CRF & ICFs
  • Biostatistics
  • Study Feasibility & Investigator Selection.
  • Preparations for Site Qualification & Site Initiation visits.
  • Preparation & submission documents to Ethics Committee
  • Assist Investigators in ICF process, Screening & Randomization of the subjects.
  • Coordinate Subjects follow-up visits, CTM and Central/Local Lab logistics.
  • Maintenance, updating & Retention of all Essential Documents.
  • AE, SAE Reporting to respective stakeholders within applicable timelines.
  • Completion of Paper/ e CRFs and resolving Data Queries within applicable timeline.
  • Correspondence with Ethics committee
  • Coordinate Monitoring & Audit visits
  • Subject Reimbursements
  • Conducting of ICH GCP Trainings.
  • Coordinating Site Close out.
  • Archival Facility.

Contact for our team

For more information please Contact on given number 9730475068