Are You Thinking Big Enough?

I’ve just been reading an interesting article by Bob Kocher, a partner at healthcare investment company Venrock. He was talking about investment in digital healthcare technologies and much of what he had to say rang so true to me about investment in eTMF technologies (and other Electronic Document Management solutions), based on some of the data that NextDocs published in their recent White Paper “The State of Trial Master Files“. His point about healthcare in America was that this is so expensive and so inefficient that if you can’t create something that saves a lot of money and/or dramatically improves outcomes, then you should reconsider whether it’s worth pursuing. After reading the NextDocs White Paper I thought to myself: “This is not cheap technology and yet people are making a significant investment and not getting the benefit.” To follow Kocher’s philosophy, is there any point in investing in an eTMF if you’re not going to do it properly?

To pick up on some of Kocher’s points that have relevance to Trial Master File solutions:

  1. Is the unmet need big enough? There are so many significant problems in our processes and systems that we should be looking to create what Kocher calls “shockingly large benefits,” and not incremental improvements. To put it bluntly, if you have purchased a document management system, then you should use it to author, develop, approve and distribute documents and not just as a document library. If you have purchased a system that permits electronic approval of documents, why are you wasting time and money continuing to collect wet-ink signatures? If you’ve purchased a system with configurable reports, why are you manually tracking activities in spread sheets and hard-copy tracking forms?
  2. Can you deliver meaningful return on investment (ROI) within a short period of time? There are myriad examples of inefficiencies in our business processes, so system implementation should focus on ideas and technologies that can capture some of that and not add additional cost. Take courier charges for example; these can amount to 5% of the cost of a typical phase II clinical trial. An efficient eTMF could save a company over £200,000 in courier costs alone for a single study by using digital document exchange.
  3. Whose money are you saving? The downside to eliminating inefficiencies in the existing system is that there may be incumbent individuals or functions currently profiting because of those inefficiencies. It is safe to assume that the incumbents will respond strongly to any disruptive technology that threatens their business model(s). Are you going to let individuals dictate the level of efficiency that is “permitted” within your organization? Change management is often fraught with difficulty but sometimes people need to just be told “Look, this is how we’re now doing things and its part of your job.”
  4. Who is your primary customer? For an eTMF, the primary customer is not the study monitor, the statistician, the study manager or even the M.D. The primary customer is the regulatory agency who will inspect your facility and expect to see a compliant set of essential documents. So how come so few organizations with an eTMF rate ‘regulatory compliance’ and ‘inspections’ so low on their list of priority features? If an eTMF is not supporting your inspections, I would question whether or not you’ve made the right investment decision. In terms of prioritized requirements, the ability to support a regulatory inspection should be Number 1.

Am I being too harsh? Maybe a little. But the underlying message is, I believe, spot on. Invest in EDMS technology wisely. Be bold. Make outrageous decisions. Reap the benefits!



About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in e-records, Records management practice, Technology, TMF. Bookmark the permalink.

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