2022 Wrapped: A New Year and a Better TMF

Concluding the whirlwind of 2022, it’s tempting to rush to make new resolutions, adopt new ideas, and embrace new goals. But before you do, it’s important to take some time to reflect. After all, we’ve accomplished so much in the past year—and so has the TMF.

More than in the past, 2022 was a year characterized by productive struggle. Both at LMK and in the entire life sciences industry, years-long efforts to master new technology coupled with the challenges of an unprecedented global pandemic demonstrated our shared resiliency and drove us all to attain more in one year than we ever thought possible.

Although it’s difficult to pick out just a few defining moments from the past year, here are the 2022 achievements we feel contributed most to a strong foundation for a prosperous new year:

We Have New Standards: In April 2022, the Trial Master File (TMF) Reference Model Group officially affiliated with the Clinical Data Interchange Standards Consortium (CDISC). This affiliation with CDISC, a standards development organization, is a significant step toward having the TMF Reference Model incorporated into regulation. In fact, many other CDISC standards are already incorporated into FDA guidance and required by the FDA as part of electronic format regulatory submissions and data analysis.

As noted in the TMF Reference Model Steering Committee’s position paper on the affiliation with CDISC, allowing CDISC to take on much of the administrative burden of maintaining the TMF Reference Model will enable the all-volunteer Steering Committee to accomplish many worthy initiatives. These include expanding the model with richer metadata, producing model-specific training materials, authoring detailed guidance, and mapping the TMF Reference Model to other models and standards. In aggregate, these benefits mean that the TMF Reference Model will have further reach, greater legitimacy, and an opportunity to become a recognized standard by regulatory agencies, including the FDA.

We Transformed the Way We Work: This past year also marked a profound shift in how life science professionals interact with the TMF. In the past, the discussion of TMF technology centered totally on the adoption of eTMF technology. In 2022, TMF decision-makers began to approach TMF technology in terms of how it can aid the people and process elements of TMF management.

More TMF professionals than ever before now regularly use advanced automation and AI eTMF features, like automatic document indexing, metadata extraction, and redaction. Instead of using inefficient manual QC processes, TMF professionals report achieving inspection readiness through automated metric generation, intelligent dashboards, and seamless integration of data from other eClinical systems. Although diverse in application, these new automations and AI eTMF features are rooted in serving the needs of users and their processes, freeing TMF stakeholders from repetitive tasks so that they can take greater ownership of trial oversight. This process and people-focused approach to AI represents substantial progress toward achieving the full digital transformation imagined when eTMF technology was first introduced to the life sciences.

We Introduced the Complete TMF Solution: 2022 also marked the first full year of LMK Clinical Research Consulting as a TransPerfect company. Joining TransPerfect, LMK Clinical Research Consulting, known for its people- and process-focused eTMF platform-agnostic consulting and education, gained access to TransPerfect’s powerful global network of life science services and technologies. Together, LMK Clinical Research Consulting and TransPerfect now offer their customers the only global, multilingual Complete TMF Solution.

The Complete TMF Solution combines the four domains that LMK Clinical Research Consulting and TransPerfect have gained industry-wide recognition for: innovative TMF education, deep expertise, powerful technology, and system-agnostic services. Uniting these domains into one values-driven organization offers clients a holistic model of TMF health unlike any other. Together, LMK and TransPerfect believe that the Complete TMF Solution is the catalyst for the simple, flexible, efficient, and collaborative TMF administration and management model that clinical trial stakeholders have been patiently waiting for.

Looking forward to 2023, we are proud to report that the state of TMF health in our industry has never been better. Our optimism about the future of the TMF, though, is only possible because of your successes and contributions to TMF excellence. Whether you’re an employee of LMK, a cherished customer, or an avid reader of our content, your commitment to continual TMF education helps us all reach our shared goal of uniting patients with the most promising new treatments. A new year presents the opportunity to build on these outstanding achievements. We can’t wait to see what it has in store for all of us.