Achieving and maintaining TMF health is HARD.
I was reminded of that fact during the Cencora TMF Leadership Summit on April 1 and 2, which was packed with insightful presentations by experienced TMF practitioners from small, mid-sized, and large sponsor companies. Our own TMF subject matter experts from around the world also weighed in with pragmatic lessons learned through hundreds of TMF customer engagements – and closing the event with an in-depth TMF lifecycle workshop that covered key best practices from trial planning and conduct through to study closeout and final archive.
More than 40 customers representing 20 companies joined us for the two-day summit at Cencora’s headquarters in Conshohocken, Pennsylvania. It was so gratifying for me and my team to see such a great turnout – with special thanks to the attendee who flew in from Japan just to attend this event. As anyone who has been around the Trial Master File knows, the TMF sparks a lot of passion.
We were also honored to provide a dynamic learning forum where these passionate TMF experts could come together, as customers told us afterwards:
“I thought the summit was a great opportunity to share our TMF knowledge and practices with colleagues at other companies. I found it interesting that companies both big and small are sharing similar experiences and facing similar challenges.”
“It was a good venue to interact with industry TMF colleagues and learn what are hot topics and pain-points for many regarding TMF. Thank you for allowing our team to come!”
Key presentations included:
- Beyond the Deal: Managing TMF Integration While Ensuring Compliance in Trials Acquired Through Mergers and Acquisitions (sponsor session)
- Standards: Not As New as You Think! (Cencora session)
- Orchestrating Excellence: Creating TMF Harmony through Collaboration (sponsor session)
- Unlocking TMF Accessibility: Streamlining Collaborative Tools to Promote Organization Adoption (sponsor session)
- Outsourcing and the TMF: Ensuring Compliance and Oversight in a Changing Landscape (sponsor session)
- From Documents to Records to Data: Expected Records and Risk Management with ICH E6 (R3) (Cencora session)
- Challenging Your Metrics (sponsor session)
- Inspection Readiness from the Start! (sponsor session)
Following is my quick take from the Summit, along with some valuable pointers gleaned from our customers. In future blogs we’ll be taking deeper dives into these topics, so watch this space. And if you’re looking for more detail on implementing Trial Master File best practices, join us on April 23 for the Cencora TMF Solutions webinar, “How to turn poor TMF quality into TMF operational excellence.”
Why is achieving TMF health so difficult? During her presentation, one customer went so far as to say that she doesn’t even use the word “achieving” when it comes to TMF quality, completeness, and timeliness. She prefers to use “approaching” – a reminder that TMF health can be an elusive goal, and one that can be fleeting even when achieved.
Perhaps the most revealing session around this challenge was the one on metrics. As the saying goes, “you can’t improve what you can’t measure” – but the TMF presents a host of complex measurement challenges.
One of these, as the presenters observed, is that even metrics showing “green” can cover up underlying issues. They recommended continually challenging all metrics, no matter how good they appear. For completeness they suggested conducting periodic spot checks of critical or outlier records, looking particularly at typical hotspots. And finally, they emphasized reviewing these metrics with clinical and quality teams.
During the active discussion around metrics, several customers also noted the value of engaging external TMF expertise on a regular basis – even if it’s only to obtain a regular “sanity check” on your own TMF strategy and processes.
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TMF Tip: Use proven tools such as TMF heatmaps to quickly obtain a detailed completeness gap analysis.
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The presenters also provided numerous examples of their approach to setting and tracking metrics, including a case study where they improved timeliness for three artifacts by 45 percent within three months. They also shared the following example of timeliness thresholds:
SOP: Documents should be submitted to the TMF no later than 35 days after the Document Date (as identified in study-specific TMF index).
It’s safe to say that no other topic created more back and forth among our attendees than how to measure timeliness. A great debate swirled around questions such as where to set the thresholds. Do you measure from when a document was received versus when it was entered into the system? How do you get clinical teams and sites to upload documents in a timely fashion? These are just a few examples of the types of questions raised.
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TMF tip: Build solid relationships with your quality assurance department and utilize them to help implement any needed process change. The quality team understands the importance of TMF oversight, and that it is a shared responsibility in the organization.
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This leads to a second recurring theme of the summit: the importance of establishing strong, collaborative relationships with internal stakeholders as well as external service providers. With TMF teams responsible for the TMF – but dependent on so many other functions for TMF completeness, quality, timeliness, and effective oversight– working closely together is a must.
One customer presented their model for how they have achieved a culture of “TMF harmony” across their organization, which has resulted in significant gains in TMF health as well as improvements in efficiency and productivity.
They were the first to admit that achieving this tightknit, collaborative culture took time and hard work, and more work remains to be done – but that the outcome has been well worth the effort.
Some of their key best practices for getting to this ideal state:
- Remember that the TMF is also a project management tool. When people recognize that and learn how to work with it, they see additional value in maintaining it.
- Create cross-functional teams of SMEs and regularly gather their feedback on what works and what doesn’t.
- Establish and track a robust set of actionable metrics and share these in meetings with internal functional groups (at the functional instead of individual level) to shine a light on where there are issues that require improvement.
- Develop quality plans to set expectations for service providers. They also hold group meetings with attendees from all their CROs, where they share current TMF metrics from all the companies – good and bad.
- Establish a single point of contact at every CRO just for the TMF.
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TMF Tip: Several presenters explained that they have developed and introduced a cross-functional “TMF playbook” for all stakeholders. These playbooks clearly spell out roles and responsibilities for the TMF across different functions and include trackers and checklists to help these functional areas understand and apply their roles more effectively.
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These observations are just the tip of the iceberg regarding the summit, and as noted we will be sharing more in the coming weeks. Thank you to our wonderful customers and our hard-working SMEs who made it possible – it was yet another reminder that among people, process, and technology, it is people who remain the irreplaceable element of TMF health.
About the author:
Jaci Spicer is Vice President, Head of Global Clinical Services for PharmaLex, a Cencora company, where she oversees all aspects of clinical development services from TMF software and services to data management, governance, statistics, and computational biology.
