While there is no regulation that stipulates TMF documentation must be kept electronically, most companies are finding that a digital solution works best—and that’s why so many are choosing eTMF. Yet with so many eTMF options available, finding the right one can be overwhelming. Look beyond the technology and select a provider that properly evaluates your business for right solution.
eTMF is delivered via an intranet document management system that lets authors create, revise and review documentation. Because print documentation is typically a part of clinical trials, the system accommodates paper documents to be scanned into the library so everything is available from a computer. It also includes the security measures necessary to protect documentation and monitor an individual’s activities on the interface. Many providers can deliver such technology, but they struggle to provide the custom approach necessary to make it really work for a pharmaceutical company.
What to Look for in an eTMF Solution
A good eTMF solution is specifically designed to bring together TMF document categories, numerous document types, descriptions and codes, metadata, and document database records. Industry standard terminology is referenced so it is easy to understand for cross-functional professionals throughout the industry. But that’s just the beginning.
To have a viable TMF solution, you have to look beyond the software platform. You need to find a provider that takes the time to assess your business’ individualized needs, understand the way employees do their jobs and ensure the right processes are in place so you get the most out of the eTMF. The most successful initiatives start with a solid business case justification and a project budget before a single product license is shipped. Choose an eTMF provider that will thoroughly assess your business needs and help you refine your internal processes to best support the application.
Understanding Business Key to eTMF Success
I see many clients who need help at all stages of a project from road mapping, requirements analysis, product selection, and implementation to training and process improvements. Regardless of the stage they are in, a client should expect the provider to conduct a needs analysis, use their expertise to develop a project plan and implement a customized eTMF in order to achieve the best outcome.
In short, the best eTMF system not only offers a comprehensive method for drafting, editing, organizing, sharing, and protecting trial documentation; it helps improve efficiency, eliminate regulatory compliance risks and saves a company money. Selecting an eTMF provider that provides a one-on-one approach is the best start to ensure you get the most out of eTMF technology.
What TMF system do you use and what challenges have you had with the existing method?
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Jamie O’Keefe leads the Research & Development (R&D) domain for Paragon’s Life Sciences Solutions, where he focuses on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs. He has over 20 years of business and IT consulting experience, with the past 9 years focused in life sciences clinical and R&D. His expertise includes increasing efficiencies in clinical site monitoring and protocol optimization, as well as implementation of electronic Trial Master Files and clinical investigator portals. He is an active member of the Drug Information Association, where he sat on the Document Management SIAC working group for Trial Master File Reference Model recommendations.