Bridging the Gap: Key Takeaways from Vendor Oversight of Data Management Panel

Effective vendor oversight is not only crucial for trial integrity, data quality, and patient safety, but a regulatory requirement. With recent ICH E6 Guideline updates and an increasingly complex vendor landscape, oversight has never been more critical, yet all too often it seems that the industry lacks consensus on how to operationalize effective oversight.  

With that in mind, earlier this year I brought together a diverse group of experts for a panel discussion on this topic. Joining me to dive into the key issues were Leticia Tarilonte, VP, Global Clinical Operations at Brainstorm Cell Therapeutics, Cory Burke, a biometrics industry leader and former Executive Director, Data Management at Black Diamond Therapeutics, Oladele Babalola, Senior Director, Data Management, Morphic Therapeutic, and Daniela Manago, Founder of Toltec Consulting, LLC. 

As I reflect on the discussion, I’m reminded of the diversity of perspectives shared. We gathered representatives from sponsor organizations, GCP experts, and service and technology providers to explore the current state of vendor oversight and discuss the most pressing gaps, all with the goal of identifying promising best practices. The conversation covered everything from alignment and communication to the critical role of technology. Here, I’d like to share five key takeaways from the panel to consider as we work towards more effective vendor oversight of data management deliverables. 

1. Alignment is Key 

Effective oversight begins with clearly defined goals and metrics, agreed upon by all stakeholders. This includes the sponsor organization, contract research organizations, and each vendor team working on the study. By setting these expectations upfront, everyone involved is working towards the same objectives, which helps prevent misalignment down the line. 

A practical approach to achieving this alignment is by establishing a cadence for regular check-ins. Whether these are monthly or quarterly, these meetings ensure that everyone remains on the same page and that any potential issues are addressed before they escalate. The importance of having the right people in these discussions cannot be overstated—those who are accountable for the goals must be present and engaged.  And, with this accountability and alignment in mind, sponsors should ensure they have a fully documented oversight plan for each vendor. It sounds simple, but the reality on the ground appears to be variable.  

2. Communication and Transparency with Vendors 

The second key takeaway is the critical role of communication and transparency with vendors, including CROs and clinical data services providers. One potential best practice- although too often not implemented- is to share your oversight plans with your vendors right from the start. By doing so, you are setting the stage for a partnership where both parties are striving towards the same outcomes. It’s also important to remember that service providers often have valuable experience working with various sponsors across different types of trials.  Leveraging their expertise can provide fresh insights and help avoid potential pitfalls. Asking vendors to share their own best practices not only enriches your oversight approach but also fosters a more open, transparent working relationship. 

3. Measurement Facilitates Management 

As was said during the panel discussion, “If you don’t track it, you won’t manage it.” Measurement is the backbone of effective oversight. Establishing clear metrics and KPIs (Key Performance Indicators) early on is essential, and these should include both quantitative and qualitative measures. While quantitative metrics like time to data entry and time to data review are crucial, they must be balanced with qualitative assessments of data quality and overall audit readiness. Tracking these metrics allows your team to identify trends and potential issues early, helping you course-correct before minor issues become major problems. And, beyond these specific elements, sponsors must consider the integrity of the process itself – in particular, how they can evidence the robustness of their oversight approach.  

4. The Interplay of Process and Technology 

Good technology can, of course, help studies run more efficiently, but it is not a silver bullet. It must be underpinned by robust processes to be truly effective. Our panel highlighted the need for an upfront investment in both technology and the processes that support it. 

For example, using centralized data systems allows all stakeholders to work from the same set of data, reducing discrepancies and improving efficiency. However, without a well-defined process for how that data is reviewed and used, the benefits of the technology may not be realized. The message here is clear: don’t just adopt new tools—ensure that they are integrated into your workflows in a way that maximizes their potential. 

5. Vendor Oversight as Part of a Broader Risk-Based Quality Management (RBQM) Strategy 

Finally, our discussion emphasized the importance of viewing vendor oversight as part of a broader RBQM strategy. This approach goes beyond simply monitoring vendors—it involves a holistic view of data quality, missing data, and other key indicators that could impact the success of a trial. By integrating vendor oversight into your RBQM framework, you can ensure that your oversight efforts are not only compliant but also strategic, focusing resources where they are needed most. 

Dive Deeper into Vendor Oversight Strategy at Our ENGAGE Conference 

These five takeaways offer a glimpse into the rich discussion we had during the panel. However, they are just the beginning. At our upcoming ENGAGE conference, we will be hosting a breakout session, “Principles for Achieving Effective Data Management” Vendor Oversight where we’ll dig even deeper into these topics by sharing our recommendations and providing actionable strategies that you can implement in your own organization. 

I invite you to join us for this session and be part of the conversation. Together, we can move towards a more consistent, effective approach that benefits all stakeholders involved. See you there! 

To view the ENGAGE agenda  and register for the event click here or visit eclinicalsol.com to learn more about the elluminate Clinical Data Cloud and our Biometrics Services.