CASE STUDY: Don’t Panic! Scaling Up TMF Operations at a Small CRO Experiencing Dynamic Growth
Growing fast means growing pains, but there’s no need to panic. Join CRO Robarts Clinical Trials as they share their journey from paper-based Document Management to paper-electronic hybrid TMF Operations and how they are navigating the challenges of scaling up under pressure:
- Rapidly growing numbers of Sponsors and trials across multiple phases and indications – and all of the associated documentation
- Increasing Sponsor oversight in response to global regulations, audits, and inspection findings
- Accommodating a high degree of variability in TMF requirements
- Building consistent TMF structure and processes
- Developing the ability to collect and analyze the data needed for evidence-based decision making without an eTMF.