3 Steps for Effective CRO Oversight & Collaboration
April 19th, 2016
What is CRO Oversight & Collaboration?
This question is frequently asked by experienced clinical operations (ClinOps) managers. CRO Oversight & Collaboration is an ongoing challenge. In the 2016 ClinOps Benchmark Report, these managers told us that their CRO relationships are often colored by change orders that cost hundreds of thousands of dollars and are caused by preventable enrollment, site productivity, and subject compliance issues.
What causes these issues? In this same Benchmark Report, teams describe their approach to CRO Oversight & Collaboration as resource-intensive, manual, reactive, and, subsequently, unsuccessful. Though 73% view CRO Oversight & Collaboration as very important, only 30% believe they are successful.
CROs typically deliver monthly reports to Sponsors, who manually compile this data into spreadsheets to diagnose areas in need of an action plan. By this time, the data is outdated and Sponsors are forced to make reactive decisions with uncertainty.
3 Steps to Avoid Quality Uncertainty
The case of an emerging biotech company explains a better approach. This company expected to enroll 240 patients across 85 sites in 9 short months for a pivotal phase 3 study. The small ClinOps team (2 employees) outsourced most of this process. To meet trial timelines, they took three steps to set their CRO partnership up for success:
1. Define Quality Agreement and CRO Oversight & Collaboration Plans
Drawing on advice of the Avoca Group, the Head of ClinOps drafted a Quality Agreement that prescribed standards, expectations, and responsibilities. Subsequently, the team developed a CRO Oversight Plan that prescribed key metrics for continuous performance assessment, process for issue management, and pre-defined thresholds for escalation. Clearly articulated and well defined, these plans were the foundation of effective Sponsor-CRO collaboration.
2. Automate CRO Oversight Metrics
To be effective, both Sponsor and CRO needed accurate and timely data to track these metrics and respond to any issues before they became delays. Using a continuous quality cloud software solution, the team implemented their CRO Oversight & Collaboration automation in a few short weeks. This easy-to-implement solution allowed the Sponsor to:
- Aggregate data to provide a portfolio-level view
- Deploy Key Performance Indicators with “outlier detecting” analytics for each component of the CRO Oversight Plan
- Configure monitors to accurately forecast issues and alert thresholds to proactively launch issue management tasks
- Enable executive visibility with dashboards and intuitive click-through capabilities to dive deep on specific focus areas
3. Manage Continuous, Real-Time Collaboration
In a matter of weeks, both the Sponsor and CRO had continuous access to their studies’ real-time KPIs and analytics. This transparency fostered an open, collaborative relationship. Proactive escalation of priority issues and clear task assignment ensured alignment on responsibility for issue resolution. Because they kept clean project files, the post-study period (from Last Patient Out to CSR) was completed in record time. Equipped with a fully auditable trail of data on the clinical trial, the Sponsor was able to address the few concerns regarding GCP compliance and make a case that these issues would be avoided in the future. Ultimately, the quality of this data set allowed the Sponsor to file with multiple regulatory agencies.
An Improved Partnership that Impacts the Bottom Line
Collectively, the team spent precious time and resources more efficiently, which, in turn, kept the trial on-time and within budget. As the extended team avoided enrollment delays, resolved outstanding issues more quickly, and reduced the number of required site visits, these benefits accrued directly to the bottom line. In this case study, clinical operations estimated over $400,000 in annual savings from more effective Sponsor-CRO collaboration. Alongside these cost savings were more qualitative benefits from lower clinical trial risk and increased clinical trial productivity.
For those facing significant challenges with clinical trial outsourcing, these three steps offer a path to improved CRO Oversight & Collaboration. Importantly, this easy-to-implement process can be in place in a few short weeks. Clinical trials following this formula will be poised for operational success, thereby increasing the chance the trial concludes on-time, within budget, and with high data quality.