“I have audited hundreds of clinical trial platforms. You guys have built by far the easiest and most well designed solution out there for starting clinical trials. And your eSignature implementation? It’s the best I’ve seen. You should issue a press release on this feature alone!”
- David Nettleton, FDA compliance specialist and CFR Part 11 guru/author.
This was the feedback I received from David immediately following a long day reviewing our SOPs. We just released our Tracker eSignature solution yesterday and I have to agree with David. It is “off the hook!”
What are eSignatures?
An electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.
Print + Chase + Sign + Fax+ Mail = Unnecessary Delays
How are legally binding documents signed today in clinical trials? Consider the study startup workflow. As a sponsor or CRO, when I am starting a clinical trial, there are numerous signed documents I require from the principal investigator/site and vice-versa. These include the CDA, 1572, contract, protocol signature page, financial disclosure form, IRB questionnaire and budget. To get these documents signed, you have to print them, chase down the authorized signatory, obtain the signature, then proceed to fax and/or mail the final copies to the counter-party. Now imagine you are initiating 50, 100 or 150 sites around the world, chasing down hundreds of documents. Does the word “cumbersome” come to mind?
The FDA is supportive of reducing paper in the clinical trial workflow. Whenever we speak to folks about eSignatures, most people agree it’s a great idea. So why the slow adoption? I believe its mainly due to a mindset of simply accepting paper as part of our process. Another is because most solutions are just poorly designed, resulting in low adoptions rates. So, we set out to build an eSignature tool that would be “iPhone” simple.
Introducing eSignatures. goBalto style.
One month was spent interviewing dozens of sponsors, CROs and PIs to understand how they went about getting documents finalized and signed. Another two months building, testing and refining our mockups & designs. After 3 months of R&D we released our eSignature feature yesterday.
Here are three reasons why you will believe our approach is radically different from others…
1) Simple, convenient and fast. What does it take to eSign a CDA on Tracker? No downloads or software needed. Simply logon to your Tracker account on your web browser, smartphone or tablet. Enter your username and password. That’s it!
2) Signature tracking. Most solutions don’t track which documents are e-signed. Tracker does. At a glance, you can see which documents are complete and which ones are outstanding. (First release allows the users to eSign the CDA. Remaining documents will be released in the near future.)
3) Part of your workflow. Tracker has been designed to guide you through study startup. You never have to go out and do something different to eSign the document. This provides you with a seamless and natural experience. Plus, it’s 100% free!
Will eSignatures alone result in dramatic cost savings? Probably not. But consider the amount of time and shipping costs you can save. It’s about chipping away at the small little things that will ultimately add up to the dramatic cost savings you should come to expect. You want to remove the mind numbing tedious tasks to focus on the important stuff.
To learn more about Tracker and how we help you speed through study startup, visit us at www.gobalto.com.
About the Author
Jae if the founder/CEO of goBalto, a venture-backed SF based company that delivers easy-to-use web products for clinical research. Prior to goBalto he co-founded Celltrion a leading biopharmaceutical supplier and was a strategy consultant at McKinsey & Company. He’s a published author and winner of the Bio-IT World Award for innovation in 2010. When he’s not disrupting the klugey eclinical space he’s mentoring startup at Rock Health and hanging with his 3 kids and wife.
About David Nettleton
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 200 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation – Ten easy Steps” (Davis Horwood International and PDA – www.pda.org) which provides fill-in-the-blank templates for completing a COTS software validation project.
