• Efficient patient recruitment program to support sites’ enrolment

  • Coordinator Support

  • Reviewing site facility, resources, source documentation practices, EC’s SOP etc. and up-scaling (as and when required)

  • Meeting the highest quality standards for protocol compliance, patient follow-up, and IP accountability

  • Periodic reporting to EC (SAEs, safety alerts, trial progress etc.) as stipulated in the approval letter

  • Meeting project deadlines for patient/volunteer enrolment and data management

  • Ensure ICH-GCP and other regulatory compliance

  • Facilitate monitoring visits by updating all essential study documents

  • Compiling regulatory documents and getting regulatory approvals

  • Writing site-specific SOPs

  • Identifying and training potential Principal Investigators

  • Site initiation, budgeting, contracting and start-up of clinical trials

  • Providing clinical sites with appropriate infrastructure and manpower