Case Study | Rescue Study | CRO Monitoring Support

Rescue Study

CRO Monitoring Support –
as a Third Party

Issue

An ongoing clinical trial supported by a full service global CRO that requires additional monitoring support to successfully meet timelines. 

Sponsor

A global, clinical-stage, specialty pharmaceutical company.

Project

Fast-paced, time-sensitive Phase 3 trial, comprised of subjects at high risk of recurrent renal cell carcinoma (RCC)  involving 28 US-based sites.

Challenge

Integration of third-party CRO (ProTrials) for additional monitoring/site payment support

  • Development and implementation of CRO integration plan-Training on current processes, systems and tools
  • ProTrials CRA(s) to establish relationships with active sites
  • Assessment of overall health of the TMF
  • CTA amendment executed prior to site payment

Solutions

ProTrials developed and implemented a detailed CRO integration plan, which included:

  • Building strong relationships with active sites quickly – a ProTrials core strength
  • Maximizing time on site as required, after building a flexible monitoring budget
  • Dedicating a single resource to audit/reconcile the TMF
  • Increasing efforts to complete SDV on site

Results

  • Converted TMF to the ProTrials TMF file structure, with QC conducted quarterly for 12 months
  • Significantly increased % of on-site SDV within first 3 months
  • Achieved aggressive data cleaning target for interim data analysis
  • Conducted 26 close out visits (COVs) in 7 weeks
  • Amended/executed contracts for 28 sites   
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