Save the trees! Paperless trials now!

Partnerships In Clinical Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

Save the trees! Paperless trials now!

How long has going paperless been a goal in clinical trials? Ever since the first remote data entry systems were utilized some 20 years ago there has been the promise of being able to one day be in a world, (clinical) that stops or barely uses paper. Maybe now that the interfaces that we utilize are fast enough, secure enough, and robust enough that this can become a reality. Maybe we are about to finally turn the corner.

When the first documented clinical trial was run back in 1025 AD in Persia by Avicenna it was recorded on, anyone…? Bueller, anyone,? Yup, paper, or papyrus back then. No way would he have ever dreamed the mountains of paper that are consumed every day/year in this industry. Between IRB’s, pharma, CRO’s, sponsors, investigators, and on and on the collection of these enormous amounts of data go on paper. But some of you will be quick to jump and point out that EDC and CTMS systems are taking away that need for cellulose. EDC sure, but CTMS, not really. CTMS systems address the process, not the paper. Yes they manage the complexity of the trial process but they do little to reduce the amount of paper generated by the study activities.

How Much Paper Really Costs

Lets look at costs both in terms of monetary and then time. The British company Datamonitor has found that on average pharma/life science companies will spend between $12-17mm per year on mailing and copying of CRF’s, budgets, contracts, etc. By being able to utilize EDC and CTMS systems that actually have in place intelligent workflow, (And not many do…), the costs could be reduced by as much as $9-12mm per year on paper and postage/courier costs alone. A single page will cost as much as $1.25 to cover just the silly costs of warehousing the paper to sit in a nice climate controlled room/floor/building. Heck the National Cancer Institute alone last year, in their estimate, generated over 100,000 pages to develop and correspond documents for their studies.

And now time considerations. Using paper forms around 15-20% of docs are shipped overnight by post or courier. Time lost waiting for someone to sign it and more time lost waiting for it to be returned. With the push by FDA and ICH to use eSigs, this is an enormous amount of time that can be saved, especially in study start-up where the number one cause for delays in trials occur. In general it takes 3-5 days per signature where as an eSig takes only seconds to complete. Factor in being able to eliminate lost or misplaced documents, jammed fax lines, jammed copiers and you can see how much time can be saved. That saving goes right to the bottom line and helps get the trial moving and ultimately the medicines to people who need them the most.

Combining interoperable digital identities, digital signatures and cloud computing in a intelligent manner will now make the paperless trial a reality. Work in the cloud in a collaborative environment on one document, no longer trying to piece together who has what version. When you add up the factors that cause the greatest delays in a trial, the most come from approval of paper. Moving to an electronic format is one of the biggest single points of reducing costs and managing time in a trial. Utilizing eTMF’s gives a huge reduction on all three.

Closing Thoughts
Is it going to happen? The question shouldn’t be is it but when will it happen. All of us are in a sense pulpwood vampires sucking down the cellulose from a tap on the forests. Embracing the power of systems on place to move to a true electronic frontier will not only save time and money but it will make a difference in the environment as well. Put aside how this goal has been politicized and just put it in terms of being able to have these big plants around just to look at and sit under. To sit under while you are working smarter on your iPad, signing docs, and shooting them over in the cloud. All use of paper will not be fully eliminated of course but the benefits of dollars saved, reduction/elimination of document errors and most importantly, speeding up the time to market for new drugs, going this way demands the change.


About the Author
Leif Erickson is a Director of Business Development at goBalto. He has over 19 years of experience in the pharma and biotech industries, including 5 years of research at 2 La Jolla based biotech companies and helped start the Diversa Corporation. To learn more about what we do and how we want to help the clinical study startup please contact Leif.