Case Study | Rescue Study | CRO Monitoring Support

CRO Monitoring Support –
as a Third Party

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

A global, clinical-stage, specialty pharmaceutical company.

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

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

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

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