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Article Blog March 17, 2017 3 minute read

Driving ICH E6 (R2) Compliance with 5 Must Have Dashboards

In our past webinar, “How Dashboards Drive ICH E6(R2) Compliance,” we explained how a sponsor with multiple CROs managed complexity, risk, and productivity along their path to ICH E6(R2) compliance.

This mid-market pharmaceutical company, with $800M in revenue and more than 1,000 employees, was managing eight studies with a small internal team and had two more studies in the wings. What’s more, the company’s trials were growing in complexity. Procedures per protocol were increasing by more than 50%. All of the trials were global. And a recent acquisition added a whole new set of data systems to the mix. Faced with these issues, the study team brought on a third CRO to help meet their clinical trial milestones.

More CROs, however, meant multiple processes and methods of management. CRO-supplied data was disjointed and incomplete, and reporting was typically delayed by more than a week, making it impossible to react to and resolve issues in a reasonable amount of time. The sponsor found it very difficult to determine priorities with limited visibility across portfolios, studies, and vendors.

Additionally, CRAs and other monitors kept abandoning the studies, reflecting an industry-wide CRA turnover rate as high as 37%. The primary causes of this are an increased workload, more complex trials, and little relief or assistance to get jobs done on time and error-free.

In summary, this sponsor was facing 3 key challenges:

  1. Complexity: Data captured in multiple systems across CROs made it difficult to plan and forecast where studies may be delayed
  2. Risk: The sponsor had no way to monitor CRO quality agreements in real time
  3. Productivity: The increase in studies, added to current workloads, was unmanageable

Dashboards to the Rescue

The study team asked us to help them refine their process for monitoring and reporting milestones across studies and vendors. Through our Clinical Intelligence solutions, we delivered five key dashboards that improved their oversight, decision-making, and ICH E6(R2) compliance capabilities:

Portfolio Dashboard

The portfolio dashboard gives the sponsor cross-study insights at a glance, and send automatic alerts when certain thresholds vary 2.5% versus planned goals. This functionality helped determine that one of their studies was severely delayed in a key milestone.

CRO and KPI Dashboards

When enrollment delays were discovered, the VP of ClinOps had the study manager analyze why things were off track. Using our CRO and KPI dashboards, the study manager monitors quality agreements in real time, as well as enrollment KPIs such as screen failures, to get to the root cause of issues that arise.

CRA and Site Dashboards

To monitor site performance and ensure that its open issue rate stays below 10%, the sponsor uses our CRA and Site dashboards to identify outlier sites and allocate resources accordingly. The dashboards make it much easier to course correct and track issues to resolution, with fully auditable documentation.

Achieving Quantifiable Benefits with Clinical Intelligence

These five dashboards described above have become the cornerstone of the sponsor’s ICH E6(R2) compliance strategy, and resulted in valuable, quantifiable benefits:

  1. Data visibility improved cycle times, saving the sponsor six months from FPI to LPO
  2. Real-time monitoring of quality agreements helped the sponsor avoid $450K in change orders
  3. Outlier identification and a built-in task management system improved CRA productivity by 264 hours per CRA

In addition to increasing productivity and managing risk and complexity, Comprehend‘s Clinical Intelligence Suite of solutions helped this sponsor become an active collaborator with their CROs. Not only did the sponsor’s performance and compliance improve, so did its vendor relationships.

To learn how Comprehend can help you use dashboards to advance your journey toward ICH E6(R2) compliance, watch our webinar now. If you like what you see, please call us at 650-521-5449 or request a demo.

Editor’s Note: Since this blog was first posted in 2017, we’ve made it even easier to manage oversight with the Comprehend Oversight Scorecard. This powerful new data visualization and analytics solution delivers a quick, comprehensive overview of risk, quality, and performance Indicators across a single study or an entire portfolio. With the Oversight Scorecard, users can monitor scores for sites, studies, countries, and vendors—based on pre-selected metrics—to make better, faster decisions.

Download the Oversight Scorecard datasheet

Saama can put you on the fast track to clinical trial process innovation.