A mid-size pharmaceutical company decided it was time to move their paper TMF into an electronic Trial Master File (eTMF) system. With so many eTMF vendors on the market and all the different functionality that these systems can perform, our client was a bit overwhelmed and requested LMK’s support with selecting an eTMF vendor.
To select an eTMF vendor that best suited our client’s corporate needs, LMK performed a documentation needs assessment by focusing on three main areas: people, process, and budget.
LMK took the time to understand the TMF stakeholders and how they contributed to the TMF: some portions of the TMF responsibility were internal and others were outsourced to a CRO. We created a matrix to review the benefits and risks of each stakeholder. Understanding the people aspect is important as it flows into the process; however, understanding the type of eTMF platform that is needed to accommodate all of the stakeholders’ needs is just as important.
LMK reviewed the current document filing practice to understand the document life cycle and filing practice at the company: Does the current practice include a first pass QC? To accommodate an electronic filing system, we had to determine which parts of the current process were sustainable and which processes needed to be revised.
LMK reviewed the company’s budget and helped them narrow the selection down to vendors that were in their price range. LMK also helped the company understand the initial setup and monthly subscription costs, how to make provisions and justifications in their overall budget for an eTMF system, the costs for retaining wet-signature documents, and destroying—yes destroying!—all other documentation that would now be stored electronically.
Everyone wants to have a shiny new system that will quickly do everything. However before selecting an eTMF vendor, it’s important to first understand the individual needs of the stakeholders, the processes the client has in place, and their budget. This client had studies within multiple therapeutic areas across multiple phases and therefore needed a system that could meet these unique needs. With these (and other) factors in mind, our eTMF experts successfully navigated the complex process of selecting the “right” eTMF solution for our client—saving them ~$1.5 million and implementing the eTMF 5 months ahead of schedule.