Adapted from a Phlexglobal Ask An Expert seminar, “How to Ensure TMF Inspection Readiness & Compliance for a Recently Acquired Product,” held March 2, 2022 and available on-demand here. First in a series; you can read the second blog – “Congratulations! You Just Acquired a Trial Master File. Now What?” – here, and the third blog, "How Quality Review and Heatmaps Can Reduce Remediation Time, Cost, and Effort for an Acquired Trial Master File" here.
Expected Pharmaceutical Mergers & Acquisitions (M&A) activities in 2022
Consulting company PWC is projecting M&A investments in the pharmaceutical and life sciences industry to reach $350 - $400 billion in 2022. This is expected after 2021 saw a 52% increase in deal volume from 2020 and a 42% increase in deal value.1
For an industry traditionally known for frequent M&A activity, new advances in cell and gene therapy and technologies such as mRNA will fuel growing interest in scientific innovations and growth. Deloitte identified failed or negative results in drug trials, the need to replenish pipelines, and the downstream effects from past megamergers and divestitures as potential catalysts for M&A activity in 2022.2
The TMF tells a story
This flurry of activity will burden R&D teams to conduct due diligence on M&A targets efficiently. The teams must then determine the required strategies to bring products, portfolios, and teams together and implement them successfully. The Trial Master File tells the story of a clinical trial and can offer critical insight into a product’s history. It can also provide powerful indicators to guide teams to develop and employ risk mitigation strategies.
Pharma M&A teams can take a page from any health authority’s inspection process. During an inspection, an investigator uses TMF content to understand how the trial was conducted, how patient safety was protected, and how compliance was maintained. Missing content, mislabeled content, and recent document dumps help the investigator understand how the team conducted the trial and whether compliance was a priority.
Inspections also help to understand the types of controls employed to protect the TMF content, who had access, and related chain of custody concerns. These issues can offer similar insights to M&A teams. A view into the TMF can trigger timely questions that can impact the outcome of due diligence activities:
- Does the TMF require extensive effort to ensure that it is inspection-ready?
- Does missing content suggest a simple, one-time training issue or a more substantive compliance concern?
- Does the TMF tell a story of a sustained commitment to proactive compliance or one of reactive and inconsistent attempts to address issues after the fact?
Assessing the Trial Master File of an acquired product can help a team understand the quality of the content, identify potential risks, and ascertain the type of effort required to mitigate those risks. The result? Organizations can minimize the time and cost involved to make the TMF inspection-ready – helping to reduce findings and avoid unnecessary delays in product submissions.
Addressing TMF issues
Ideally, the TMF review is included in any pre-M&A activities. Whether during due diligence or after an M&A deal is completed, once issues are identified, it is imperative that the clinical team responsible for the TMF act quickly to request missing information and fill in any gaps – since some contracts prohibit the exchange of data and documents after a specific timeframe.
In addition, the contact for a particular clinical trial often moves on to a new company. They then take all their knowledge of the trial, and where documents and data are located, with them. If the trial is older or the acquisition happened a few years ago, it can be extremely difficult, if not impossible, to go back years later to find critical Trial Master File content.
A note about acquiring an eTMF
An electronic Trial Master File may have similar issues to a paper TMF. However, in an eTMF, in addition to essential documents, an audit trail is required. When an eTMF is exported and migrated to a new system, the audit trail should be included in the migration discussions and ensuing strategy to ensure continued compliance.
Ensuring a successful transition
At a time of heightened M&A activity and increasing regulatory scrutiny, the Trial Master File continues to play a critical role in defining the value of a development product. If you are assuming responsibility for an impending acquisition product, contact Phlexglobal to learn how we can help you assess the TMF and use our proven strategies to ensure a seamless and successful transition.