At CDISC Europe 2026, we explored a simple but important idea: the challenge with TMF metrics isn’t what we measure - it’s how we use them.
Across the industry, organisations have strong foundations in place. Completeness, quality, and timeliness are well-defined, consistently tracked, and embedded in dashboards and governance.
Yet common challenges persist, including recurring quality issues, inspection pressure, and late visibility of risk. The reason is often not a lack of data, but a lack of perspective.
Most TMF oversight operates at the study level. This approach is effective for managing day-to-day performance and responding to immediate issues.
However, it also creates blind spots:
When we stay focused on individual studies, we see activity, but not always insight.
A portfolio view simply means looking across studies with intention.
It is not about adding more metrics, but about connecting existing data and applying consistent definitions so it can be meaningfully compared.
This shift enables:
Ultimately, it moves TMF management from reactive monitoring to informed decision-making.
One of the most valuable outcomes of a portfolio perspective is the ability to uncover patterns that are not visible at the study level.
When data is viewed across studies, organisations often identify:
This changes the conversation from: What is happening in this study?
To: What keeps happening across our studies?
That distinction is key to understanding and managing risk effectively.
A portfolio view makes TMF data more actionable.
Across core processes such as document QC, quality review, heatmap analysis, and TMF health metrics, aggregated insights help distinguish:
This creates opportunities to:
Importantly, it shifts the focus from resolving individual findings to learning and improving across the organisation.
A portfolio perspective also transforms how organisations approach inspection readiness.
Rather than relying on point-in-time assessments, it enables:
In this context, inspection readiness is no longer a milestone - it becomes a sustained state.
Adopting a portfolio view does not need to be complex.
A practical approach is to:
A useful starting point is to ask: What keeps repeating across my studies?
The value of TMF metrics does not come from measuring more. It comes from seeing more clearly.
By shifting from a study-level view to a portfolio perspective, organisations can move beyond snapshots of compliance to a more complete picture of control, consistency, and performance - ultimately improving both TMF quality and inspection readiness.
Jacki Petty, Associate Director, Study Resourcing & Consulting
Jacki brings 20 years of TMF experience to Phlexglobal, now heading up the Study Resourcing & Consulting group, leading global teams and delivering practical, user-friendly TMF solutions. With a people-centric approach, Jacki is known for driving project health and customer satisfaction through data-led insights and continuous improvement.