SERVICES
Our panel of Project Management services includes:
Project Management plans include a communication plan, escalation, risk management, study initiation to close out activities, and timelines
Regular internal or external study meetings with sponsor and internal teams Development of Trial Master File (TMF) and Investigator Site files
Quality Control Plans include a procedure to escalate significant GCP non-compliance and regulatory inspections
Trial Status Reports (TSR)
Study Progress Reports
Submission of study reports to regulatory authority (e.g. CHMP), if needed