It’s funny. I write these posts usually twice or more per week not knowing who, if anyone, is reading them besides blog reporters (e.g. FDA News (Related) , which has generously featured my posts in its daily drug newsletter on numerous occassions), blog aggregators (e.g. Seeking Alpha (Related) …ditto), the PR firms that service big pharma (e.g. Edelman (Related) ; looks like Pfizer (Related) ’s an important client) and, of course, the search-engine spiders. So I probably shouldn’t care about not posting for a week or two, especially when it’s due to competing activities that involve me receiving compensation for my thoughts, but I do. I’ve missed the ritualistic dispersal of my ego to the ether and have even felt a chill of guilt reading through other editorialists’ musings the past couple of weeks. This makes me think the act of writing the posts provides some catharsis for me, one that was particularly important when I left my last job at big pharma to start my own businesses. Who knew? I thought I was providing a service for others, not for myself.
Anyway, I’m no longer on my own, as I’ve become an employee with an established business called Fast Track Systems (Related) . If you’ve been in the biz for a while, you might remember them as Data Edge, the company that supplies most of the pharmaceutical industry with clinical trial/CRO contracts data that are a must-have for benchmarking trial and related outsourcing costs (for planning, negotiation, and audit purposes). They’ve re-branded, but they still supply the industry with these data, now provided under the collective name TrialSpace (the PICAS clinical “grants” data are now in TrialSpace Grants Manager and the CRO data are in TrialSpace CROCAS). These data products and related services remain Fast Track’s core business, but in the last few years they’ve hired a young, visionary CEO to build new business in the eClinical space. I joined them because of their vision but also because they’re delivering on it…now.
Peruse my back collection of posts and you’ll find numerous references to the urgent need for pharma R&D to come up to speed process-wise with other research-based industries. Clinical research, in particular, has badly lagged not only other industries but also the rest of pharma’s research enterprise in its adoption of time- and cost-efficient operations. There’s no direct evidence to explain this lag, but I believe it’s largely because of inertial forces in the form of past industry successes (i.e. the really good years), whereby clinical research costs are relatively unconstrained in the face of high returns on R&D investment. It’s also likely related to the general inertia to process change that pervades medical practice. Doctors still write office notes and prescriptions on paper for God sakes. As medical practice comes out of the paper age, so too will the industries that serve it.
Which leads me to the eClinical (can someone please invent a better word) paradigm shift (can someone please invent a better phrase) now occurring in the life science industries. The move away from paper-based information flow and its associated processes towards electron-based information flow and its associated processes is absolutely necessary to restrain growth in clinical research expenses. It will do so by improving productivity (the amount of work output for any unit of resource input), reducing cycle time (the time needed to complete a task), and potentially (no, it’s not yet been proven) by increasing technical success rates of therapies that reach the clinic.
I’ll have much more to say about the eClinical revolution in the months ahead. For now, though, I’ll simply say that I’m genuinely excited to be part of a visionary enterprise that is working hard to make this shift occur quickly and as painlessly as possible. The technology is here, and it’s ready to be used now. Are you ready for it?
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