In my last post I focused on the factors that define a truly robust eTMF system (see “Does your eTMF work for your business, or against it?). If you’re sold on the need for a new eTMF to move your company into a robust maturity state, you have to start with the solid business case preparation. Foundation work does not have to be redundant, reductive or wasteful. There’s no need for death-by-committee or analysis paralysis – the tasks for building the business case can be accomplished in a few short weeks. But ignore them at your peril – avoiding the foundation work will show up later, in painful post mortems, wasted time / expense pre-launch, or worst case project derailment. There’s no getting around the basics if you want to ensure success. Diving into the business case factors is illuminating and interesting, and can even be fun. You’ll learn a lot, and you’ll be well prepared for the next phase of the journey.

Here are a few factors associated with building a solid business case:

  • Assessing organizational maturity. Who are the people and what do they do? What is the current process and where is it broken? What would we like to change and what has to change? The inputs and outputs for content, people and process must be understood at the start of your project. And note I don’t say fully understood, since more will be uncovered further into the project – that’s expected and welcomed. What is required at the start is a first solid cut at the answers to the questions above.
  • Identifying the risks and benefits. Here’s where you play with the “what if” questions, and lay out the possible outcomes. What is the impact of no action? Of completing the project in three years? In six months? What are the corporate change factors (major partnership? planned outsourcing?) Impact of competitive business drivers or other technology projects? How much change can the organization handle? Clear assessment of the risks and benefits drives direction and decisions, and as a bonus adds more meat to your elevator pitch.
  • Delving into eTMF value. There are many facets of costs to an eTMF rollout. Beyond project expense and capital expenditures, there are also productivity and opportunity costs. All the anticipated cost areas of the program need to be recognized and balanced to the eTMF value. eTMF value is found in various factors, and I believe it shortsighted to rely on direct cost savings post rollout. Even before the all the numbers are known, knowing the likely cost factors and potential value is required information for your business case. At the end of the day, the WIIFM (what’s in it for me) value to the participants and to the company must be higher than the costs.
  • Setting the table for stakeholder alignment. Oh, and by the way, what is in it for me? The software productivity principle is: it’s not the software that’s productive; it’s the people who use it. If the people won’t use it, or don’t use it correctly, or executives won’t support the program in the first place, your eTMF will not get off the ground. You need to include assessment of all the players, understand their motivators, identify who will support and who may object, and find your executive sponsor.

I am discussing the business case factors, as well as eTMF Maturity Model, reflections on the vendor landscape, and effective success strategies during a presentation entitled “eTMF System Selection: Considerations for your Organization” at the upcoming European Trial Master File Summit in London on October 22-23. (link to event). I’m also gratified to be on an interactive panel with other experts discussing the TMF Reference Model V2.0. The panel will address the model’s uptake in industry, revealed in our TMF RM survey to have grown from 32% in 2010 to 59% in 2012, and discuss success factors in model adoption. It will also cover new details on investigator-initiated studies, implementation and use of process-based metadata, and new subteam initiatives for 2013. Version 2.0 was released this past June, so there will be plenty to discuss.

Are you ready to leap into robust eTMF? Do you struggle with TMF Reference Model adoption? Welcome your thoughts and feedback!

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