Rethink Your Study Team to Reimagine Your TMF

For the last several decades, clinical study teams have been structured according to the Full-Service (FS) and Functional Service Provider (FSP) outsourcing models. [1][2][3] The FS and FSP outsourcing models have grown in tandem with the prevalence of CROs and have been the main catalyst for their growth.

In the FP model, entire clinical studies are outsourced by a sponsor to the CRO. In many cases, the sponsor adopting this model does not need any in-house clinical specialists and can minimize interaction with the CRO to one or a few points of contact. The FSP model, in comparison, is a hybrid outsourcing model in which a CRO provides specialist staff to the sponsor to perform specific tasks. The CRO’s staff are often assigned to the pharmaceutical company in a dedicated manner and can even operate under the SOPs and processes of that company, as if it were a department in the sponsor’s organization.

The benefits and risks of these outsourcing models are well known, and the relative value of these models have been argued continuously since their introduction. There is, for example, remarkable efficiency, simplicity, and convenience for the sponsor with the FP model. With the FSP model, there is much of the convenience and cost savings of the FP model but with greater flexibility and scalability—that is particularly useful in therapeutic areas where expertise is both essential and in short supply. Regardless of their pros and cons, however, no one can deny that the massive, multicenter, randomized clinical trials necessary to support modern treatments and meet regulatory expectations would be unfeasible without the increased efficiency and cost savings of outsourcing models.

While the advantages and disadvantages of outsourcing are frequently debated, less common is discussion of how these outsourcing models end up shaping the sponsors who adopt them. When a business process becomes outsourced, it must be parsed into the language of customer and vendor. Instead of organizing around roles, responsibilities, and goals, study teams have been reorganized based on the services offered—whether or not that team structure is what’s best for the function of a study team. The result of these mismatched incentives is that the modern, decentralized study team struggles to unite behind the TMF, which requires exacting cross-functional coordination for success.

The TMF and the Modern, Decentralized Study Team

A few months ago, Sholeh Ehdaivand, Founder of LMK Clinical Research Consulting, posted on LinkedIn reflecting on industry-wide TMF challenges. In her post, Ehdaivand recalled her years of experience working with CROs and sponsors who usually express the study team composition in a “daisy” graphic. This study team daisy portrays each of the many functional lines as petals, with the whole daisy representing a complete study team. These task-oriented functional lines (clinical operations, data management, medical monitoring, biostatistics, regulatory affairs, and safety) are familiar to anyone who has worked in clinical research.

Ehdaivand notes that many of the TMF challenges that organizations face today stem from TMF passivity. A passive TMF is like a dusty filing cabinet where documents go, never to be seen again. It is a ship without a rudder: nobody is ensuring the TMF is complete and contemporaneous or curating the narrative within the TMF. A passive TMF is an omnipresent burden to all stakeholders and offers little benefit other than fulfilling the regulatory requirements. In contrast, the ultimate TMF goal is to achieve an active TMF. A modern, active eTMF is complete, contemporaneous, and correct from the start of the clinical trial. When used to its full potential, it is a paradigm-changing, proactive trial management tool that will return your investment of time and effort by a factor of ten.

Ehdaivand’s post isn’t meant to shame TMF stakeholders about TMF passivity, but rather points out an obvious drawback to the structure of the modern, decentralized study team. Functional lines are tightly focused on their own discipline, metrics, and goals. These encapsulated teams often work in separate buildings, rarely communicate with other functional lines, and are seldom assigned to a clinical trial from beginning to end. But, in the current model, these siloed specialists are expected to work together to contribute TMF documents telling the unified story of a clinical trial. In such a model, where few are empowered to leverage the potential of an active TMF, it is not so difficult to understand why TMF challenges are common.

The Complete TMF Solution

In several previous posts, we’ve discussed how the merger of LMK and TransPerfect gives their customers access to the first and only global, multilingual Complete TMF Solution. In those posts, we’ve talked about the key elements and philosophy behind the Complete TMF Solution but have waited to discuss the real-world application.

Today’s CROs proudly sell the services of their study managers, statisticians, regulatory affairs consultants, and monitors to potential sponsors. Few CROs, however, flaunt their TMF expertise or even consider TMF management a discrete service worth selling. Even when a study team is assembled, nobody is a clear champion of the TMF. In an industry that values expertise, accountability, and experience, this exclusion of the TMF is a notable outlier. TMF passivity, it seems, has been built into the very structure of the clinical team.

The Complete TMF Solution empowers your team to achieve and maintain an active TMF through a clear, unified TMF health solution. In Ehdaivand’s post about the study team daisy, she ultimately recommends that TMF management be considered its own petal and, therefore, its own functional line.

The merger of TransPerfect and LMK takes Ehdaivand’s vision of the TMF-empowered study team one step further by democratizing TMF expertise for business of all sizes. The Complete TMF Solution is now ready to assist businesses in all markets with achieving their TMF goals:

• LMK’s TMF consultants can help any study teams achieve completeness through the development of uniquely tailored TMF indexes and tools, no matter the eTMF system or the size and location of the TMF.
• TransPerfect’s study owners can build and configure the right-size eTMF solution for any study team and even the most rapidly growing business.
• TransPerfect’s document services team can free any study team from repetitive tasks like document filing, indexing, and scanning to enable focus on higher-level TMF strategy.
• LMK’s TMF educators can empower any study team to take control of the TMF through industry-leading classes, battle-tested best practices, and well-considered TMF metrics—often using functionality already present in the average eTMF system.

In every domain of TMF health, there is an expert at LMK and TransPerfect who is ready to help you rethink what your study team can accomplish. We are ready to be your high-performance TMF management team or to empower you as you build your own. Regardless of the services you need, our goal is to guide your journey from the stress and burden of TMF passivity to the peace and clarity of active TMF management. Your team’s goals, distinct needs, and unique culture define the path. The power of the Complete TMF Solution guarantees that the destination of a reimagined TMF is available to everyone.

 

[1] https://www.appliedclinicaltrialsonline.com/view/the-rise-of-fsp-outsourcing-in-drug-development

[2] https://www.contractpharma.com/issues/2020-06-01/view_features/functional-service-provision-vs-full-service-outsourcing/

[3] https://www.contractpharma.com/issues/2020-06-01/view_features/functional-service-provision-vs-full-service-outsourcing/