The Framework for TMF Success: People, Process, and Technology

For years, LMK Clinical Research Consulting has described the TMF in terms of an operational framework of people, process, and technology. These three elements, known by many as the TMF Trifecta, represent the real-time interplay among TMF stakeholders, the actions those stakeholders take, and the technology necessary for them to carry out their role successfully and efficiently. Through the lens of the TMF Trifecta, TMF leaders possess a conceptual framework with which they can overcome even their most difficult TMF challenges.

To celebrate LMK Clinical Research Consulting & TransPerfect’s continued success, we want to share some of the top case studies and blog posts showcasing how our clients have achieved TMF success by revitalizing the people, process, or technology elements of their own TMF Trifecta.

People: The people element of the TMF Trifecta is vital in achieving TMF success. Proper training and education of TMF stakeholders are essential to ensure that they are equipped with the knowledge and skills required for their roles. For a firsthand account of how LMK’s training can transform the people responsible for your TMF, read LMK’s case study Trial By Fire: A TMF Training Case Study, which describes how one new hire overcame her trial by fire and became part of a new generation of TMF professionals. LMK supports life science companies of all sizes as they invest in the knowledge and skills of their TMF stakeholders. TMF University, the first internationally recognized and accredited certification program for TMF professionals, allows TMF professionals of all backgrounds to access real-time and asynchronous remote TMF learning courses designed to meet any level of expertise. Did we mention that TMF University is the world’s first and only accredited training program designed specifically for all parties who interact with the TMF! TMF University is accredited by IAOCR, the international accrediting organization for clinical research. IAOCR is the only organization in the world to qualify Clinical Research Professionals to international standards. Through robustly accrediting the competence, IAOCR reduces risk—to patients, clinical research and organizations—whilst improving compliance and bring drugs to market quicker. IAOCR business processes and accreditations have been built specifically for the clinical research industry. They provide a quality mark to organizations committed to globally consistent, high quality clinical trials workforces. In addition to TMF University, LMK’s extensive portfolio of non-accredited corporate education courses is designed to tackle the TMF training and educational needs of corporate clients, both large and small. Most importantly, each course can be customized by LMK’s TMF consultants to produce a learning experience individualized to any company’s real-world TMF environment—even using your current TMF system, processes, and document templates. For a deep dive into LMK’s TMF Corporate Education Program, read LMKs blog Top 4 Ways TMF Corporate Education Can Revitalize Your TMF. Industry organizations and regulatory bodies, such as ICH, FDA, EMA, and WHO also emphasize the importance of proper training and education of TMF stakeholders. These organizations provide guidelines and best practices for TMF management that emphasize the need to ensure that TMF stakeholders are properly trained and educated. Proper training ensures that functional area experts who do not frequently file TMF documents have the foundational knowledge necessary to use the eTMF and to identify which of their documents must be filed in the TMF.Providing clinical operations and TMF specialists with the knowledge, tools, and confidence they need to effectively interact with other functional areas regarding TMF quality, even if they are not an expert in a certain discipline TMF training also creates a low-stakes environment for TMF and clinical operations professionals to come together with functional area experts and brainstorm effective processes and means of communication. When healthy TMF relationships are forged across functional areas, subject matter experts will find their TMF responsibilities are manageable and TMF specialists will find the narrative in their TMF unified, coherent, and complete.

Process: The process element of the TMF Trifecta is critical in achieving TMF success. A well-defined process ensures that all TMF stakeholders understand their roles and responsibilities in managing the TMF, and that they understand the importance of timely and precise documentation. It can also help to ensure that TMF documentation is complete, accurate, and consistent, which is essential for regulatory compliance and inspection readiness. Process improvement is an ongoing process that requires continuous monitoring and evaluation. LMK Clinical Research Consulting offers TMF process audits to identify areas for improvement and ensure that processes are being followed consistently. By conducting regular TMF process audits, companies can identify areas for improvement and implement changes to improve TMF efficiency and compliance. To learn how LMK’s TMF experts empowered a growing sponsor to take back the reins of their TMF processes from a service provider, read LMK’s most-read case study, From Reactive to Prospective: A TMF Transformation. Both TransPerfect and LMK Clinical Research Consulting offer eTMF implementation, management, and consulting services to help any size life science company implement, execute, and perfect their TMF processes. With our cloud-based solutions and document management systems, the entire network of LMK and TransPerfect’s TMF records management staff, TMF support analysis, and TMF consultants is immediately deployable anywhere in the world. Our scalable TMF solutions are designed to strengthen your clinical oversight and free your team from administrative burden so that you can direct your effort toward achieving the success of your team or business.

Technology: The technology element of the TMF Trifecta is equally important in achieving TMF success. Technology plays a critical role in the efficient and effective management of TMF. A metered approach to eClinical technology is especially important in the highly complex and heavily regulated life sciences industry and is also paramount to our philosophy of TMF Choice, which you can read more about in our recent blog Who Needs TMF Choice? TransPerfect Life Sciences’ eClinical Technology, Trial Interactive, is an industry leader in practical, global eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and trial sites around the world. For a firsthand account of how Trial Interactive is the premier eTMF technology, read Trial Interactive IT Facet Sheet & Here’s to Your eTMF Health . Beyond offering Trial Interactive as a TMF agnostic service provider, LMK Clinical Research Consulting’s TMF consultants and analysts offer customized services, deep expertise, and scalable support regardless of your chosen eTMF system or other eClinical technology. While it’s true that technology plays an increasing role in everyday life, our most successful clients chose to leverage LMK and TransPerfect’s people and process solutions in conjunction with eTMF technology, ensuring complete integration of their eClinical tools with industry-standard best practices and processes.

In conclusion, The TMF Trifecta framework highlights the importance of balancing the people, process, and technology elements to achieve TMF success. LMK and TransPerfect’s Complete TMF Solution offer a streamlined service offering that empowers and enriches the people, process, and technology of a TMF through education, deep expertise, powerful technology solutions, and scalable system-agnostic services. This simple, flexible, efficient, and collaborative model of TMF health is designed to return balance to all of the elements of a TMF Trifecta.

To achieve TMF success, companies must invest in the knowledge and skills of their TMF stakeholders, perfect their TMF processes, and leverage technology to improve the efficiency and effectiveness of TMF management. The TMF Trifecta framework proposed by LMK Clinical Research Consulting provides a holistic approach to managing TMF, highlighting the importance of balancing the people, process, and technology elements. Companies must adopt a comprehensive approach to TMF management, ensuring that all three elements.By equipping the next generation of skilled TMF professionals to implement—and perhaps even create—the next great TMF innovation, we believe we are taking a powerful step towards eliminating the TMF skills gap and realizing the transformative promise of eTMF technology.