Utopia: The Paperless Clinical Trial

When we think about the Life Sciences industry, utopia is the paperless clinical trial: that elusive world in which everything is electronic — from forms to signatures to submissions and approvals. No paper, wet signatures or overnight mail.


4 February 2010

In a utopian community, the beauties of society reign — perfection, harmony, peace, happiness, sunshine, red velvet cupcakes, coffee from that place on 44th & Lex (oh, wait… that’s getting into my specific vision of utopia!) — and the evils of society are all removed — pain, suffering, inequality, freezing rain, subway delays and aggressive taxi drivers (oops — there I go again!). You get the picture. When we think about the Life Sciences industry, utopia is the paperless clinical trial: that elusive world in which everything is electronic — from forms to signatures to submissions and approvals. No paper, wet signatures or overnight mail.

For the paperless clinical trial to exist, a few things need to be in place. At a very high level, there must be:

  1. Interest and willingness of the community to part with paper
  2. Regulatory acceptance and encouragement of electronic documents and processes
  3. Technology to support all documents and processes electronically
  4. Standards and best practices

With regard to the first item, clearly, the interest and willingness is there. When I talk to members of the clinical trial community, everyone wants to get away from the mountains of paper associated with clinical trials. There isn’t one person who doesn’t support this movement, or yearn for this utopia. This interest is also reflected in the session and panel topics you see today at industry conferences and events.

The next three items were actually the topic of discussion in a recent Intralinks-sponsored webcast, “The Journey Towards Paperless Clinical Trials.” In this webcast, we examined industry progress to date, current trends and initiatives, roadblocks to success and thoughts on how to overcome those hurdles. One of the audience polling questions asked was, “What do you feel is the most challenging roadblock preventing wider adoption of paperless trials?” Here’s what the audience said…

What do you feel is the most challenging roadblock preventing wider adoption of paperless trials?

This response indicates that the community feels that the technology to allow for paperless clinical trials is available and regulatory support and standards are not really a problem. Security is a bit of a concern, but the overwhelming challenge appears to be the time and training needed to implement a new process. So, does this mean the only thing standing between the industry and utopia is… implementation?! OK, I’m being a little flip, but really, we should be able to tackle this, right?

I read a quote once that kind of stuck with me, “Software systems do not fix bad business processes; they can only improve successful ones.” Think about that. So, might it be that the “time and training needed to implement a new process” is actually due to the fact that current processes are bad? And probably “bad” is not exactly the right word; rather, “inefficient and difficult” is a more accurate description. When we talk about implementing a solution like Intralinks for clinical trial communication, we often find that what we’re displacing is “the old way” — manual, paper-based processes. So, to move towards making the paperless clinical trial a reality, not only will your global clinical teams and sites need to be trained on new technology, you are also likely going to have to redefine and re-write bad processes (the clunky, inefficient, human-error-prone paper processes you have in place today). Truth be told, implementing a technology solution may not take that much time and training. If it’s a SaaS-based solution like Intralinks, there isn’t any implementation, maintenance or support burden (all of that is managed by the vendor), and often (as is the case with Intralinks), user training is provided in an on-demand “eLearning” format that users can easily complete at their convenience. That said, perhaps it’s the task of having to redefine and re-write bad processes that is the most challenging roadblock?

Again, in utopia, the beauties of society reign (i.e. smart technology that improves processes) and the evils of society are all removed (i.e. bad processes). I think the latter is really the challenge in achieving paperless clinical trials, not the former.

If that is the case, what can the pharma companies, CROs, sites and other players in the clinical trial process do to overcome this challenge?