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CASE STUDY: Don’t Panic! Scaling Up TMF Operations at a Small CRO Experiencing Dynamic Growth

12 Sep 2019
11:30am-12:15pm

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.