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Governance serves as the backbone of successful clinical trial partnerships, ensuring all stakeholders remain aligned, accountable, and transparent. It provides the framework for measuring performance and knowing what to do when things don't go according to plan. Without effective governance, even the most well-designed trials can encounter significant roadblocks that derail timelines and objectives.
Governance frameworks have traditionally relied on operational metrics or Key Performance Indicators (KPIs), like adherence to timelines or data entry speed. These KPIs play a critical role in maintaining the governance structure by providing the metrics used to assess performance, ensure compliance, and foster transparency between vendors, Contract Research Organizations (CROs), and sponsors. But while these compliance and operational KPIs serve their purpose, they can miss the bigger picture of what truly makes sponsor/vendor partnerships successful.
Are operational metrics alone enough to guide complex partnerships?
When you’re looking at a broader portfolio of 10, 50, or 100 studies, do operational metrics reveal if your vendor is operating as your partner? Can they give you insight into how well your teams collaborate or adapt to unexpected challenges?
Most governance frameworks today rely on traditional, operational KPIs such as:
These metrics, while valuable, share a common limitation: they're all reactive indicators. They tell us what has already occurred rather than provide insights into collaboration quality or strategic alignment. They offer a snapshot in time but don't reveal the underlying dynamics that drive success or failure.
Consider two real-world scenarios that illustrate the problem:
A Perfect Timeline Hides a Systemic Problem
They KPI dashboard on the left shows 100% of studies went live on time across three quarters—an apparently stellar performance. However, the reality behind this metric was that teams worked nights and weekends for a month due to improper resource allocation. The study was underscoped and assigned junior resources inappropriate for its complexity. While the metric looked great on paper, it masked significant partnership strain and resource management issues. In the end, the misleading metrics make it more challenging to justify additional resources or make other changes because the data shows you went live on time.
The "Failed" UAT That Succeeded
A User Acceptance Testing (UAT) metric showed only 50% completion on time, marked as red on the governance dashboard on the right. The reason Q3 only showed 50% completion, however, was because the client used this as a training opportunity for two new employees, helping them understand both the protocol and the Randomization and Trial Supply Management (RTSM) system. This approach had a net positive impact on the relationship and improved long-term site support capabilities, but it showed up as "poor" KPI performance on the dashboard.
Traditional KPIs lacking additional contextual information are prone to misinterpretation and may prevent teams from addressing underlying issues or recognizing positive collaborative efforts.
Strategic KPIs can transform governance into a tool for deeper alignment and trust. They represent a fundamental shift from reactive measurement to proactive partnership building. Rather than simply measuring outcomes, they're designed to enhance the processes and relationships that lead to those outcomes.
Strategic KPIs fall into three key categories:
1. Collaboration Quality
These metrics assess how well teams work together, measuring factors like communication effectiveness, stakeholder satisfaction, and cross-functional coordination.
2. Proactive Issue Resolution
Rather than just counting problems, these KPIs measure how quickly and effectively teams identify, address, and prevent issues from recurring.
3. Alignment with Sponsor Expectations
These metrics ensure that vendor activities and priorities align with sponsor objectives, whether focused on innovation, traditional delivery, or specific therapeutic area requirements.
Successfully implementing strategic KPIs requires a thoughtful, collaborative approach:
Step 1: Define Objectives Clearly
Just as sponsors aren't one-size-fits-all, neither should KPIs be. Some sponsors prioritize innovation and want the latest technology and AI capabilities. For these clients, strategic KPIs might include technology adoption rates or percentage timeline reduction quarter-over-quarter. Others prefer traditional delivery models and stability. The strategic KPIs for these relationships should reflect different behaviors and priorities.
Step 2: Engage Stakeholders From All Sides
This should involve active conversations between vendors, sponsors, and CRO teams to understand pain points and success factors. The goal here is to ensure the right KPIs are selected to add value and insight at the partnership level, not just check compliance boxes.
Step 3: Use Both Quantitative and Qualitative Metrics
Supplement traditional quantitative measures with qualitative feedback. For instance, if UAT timing appears problematic, add UAT satisfaction surveys or post-mortem reviews to understand the full picture.
Step 4: Refine Iteratively
True partnership is a lot of work and requires ongoing attention. Regularly review and adjust KPIs during governance meetings to ensure they remain impactful. As client priorities evolve, strategic KPIs should evolve accordingly.
To illustrate the power of strategic KPIs, consider these side-by-side comparisons:
Net Promoter Score Enhancement
End users of a particular RTSM study gave feedback on how they felt using that RTSM for that study.
Traditional view
NPS scores of 20 in Q2 and 22 in Q3 (left) show modest improvement and could continue to improve incrementally.
Strategic addition
Adding a Feedback Loop Effectiveness Score, which shows remains unchanged at 30% across quarters, reveals that feedback isn't being integrated into system updates or that the real cause of the feedback is not being addressed at all. This indicates misaligned expectations and a lack of proactive issue resolution. This should be a big signal for a vendor thinking about how well they are partnering with their CRO.
Bug Resolution Analysis
Here is a dashboard showing the average number of bugs per study in the first 6 months following go-live.
Traditional view
Average bugs per study dropped from 5 to 1 between quarters. This is excellent progress.
Strategic addition
Adding average resolution time reveals an increase from 1 day to 1 week. This could suggest many things around resource reallocation or a decreased sense of urgency when volume dropped.
Training Impact Assessment
Here is a dashboard for number of data change requests resulting from end-user error, which cut in half from one quarter to the next.
Traditional view
Data change requests due to user error dropped from 10 to 5. This is strong improvement.
Strategic addition
Trial staff training completion rates are rising while data change requests are falling. This shows proactive partnership behavior. The causes of the errors are being addressed, and the strategy for addressing them is working.
For CRO leaders and stakeholders, the question isn't whether to implement strategic KPIs, but how quickly and effectively they can be integrated into existing governance frameworks.
The key questions to consider are:
The evolution from traditional to strategic KPIs represents more than just a measurement shift, it's a fundamental change in how we approach clinical trial partnerships. By incorporating KPIs that measure collaboration quality, proactive issue resolution, and alignment with sponsor expectations, we create governance frameworks that enhance partnerships.
Strategic KPIs don't just measure performance; they create value by providing visibility into behaviors and collaboration that are difficult to spot with operational metrics alone. When properly implemented, they help chart a roadmap for where partnerships should go while holding all parties accountable for getting there.
As the clinical trials industry continues to evolve, with increasing complexity and higher stakes, success will depend not just on meeting timelines and compliance requirements but on building strong, collaborative partnerships that can adapt to challenges and drive innovation. Strategic KPIs provide the framework for making this transition, transforming governance from a compliance exercise into a tool for building stronger, more effective partnerships that ultimately improve clinical trial outcomes.
Would you like to learn more about how Endpoint Clinical can be your collaborative clinical trial partner? Contact us today to discuss your needs.
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