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