Comments on: Wide Adoption of Electronic Signatures and Electronic Contracts Overdue http://alphatechcounsel.com/blog/2010/wide-adoption-of-electronic-signatures-and-electronic-contracts-overdue/?utm_source=rss&utm_medium=rss&utm_campaign=wide-adoption-of-electronic-signatures-and-electronic-contracts-overdue Legal and Business Issues for Entrepreneurs and Emerging Companies Tue, 17 Jan 2012 16:39:28 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: Dan Manak http://alphatechcounsel.com/blog/2010/wide-adoption-of-electronic-signatures-and-electronic-contracts-overdue/#comment-105 Dan Manak Fri, 23 Jul 2010 12:38:34 +0000 http://alphatechcounsel.com/blog/?p=318#comment-105 Matt and Macy, Thank you for this post, it is very informative and you bring up many relevant points. I used to manage an SMO (Site Management Organization) and processed about a hundred site start-ups per year. Study start-up in clinical research is a very paper heavy process and the shipping of documents boarders on extreme. I am glad that you mentioned the use of esignatures specifically within pharmaceutical FDA regulatory requirements. In my opinion, the use of esignatures is extremely underutilized in both: the regulatory and contracting process involved in study start-up. The financial implications of the industry adopting esignatures as the norm is staggering. As an example look at a phase III trial involving 300 US sites. The minimum number of instances in activating a research site when esignatures could be employed is 3: assuming the regulatory pack can be settled with one exchange between sponsor and site, 1 contract + 1 contract amendment. For each instance there will be 3 shipments (sponsor to site for site signature, site to sponsor for full execution, and back to site for filing). The average cost for shipping (it is standard for pharma sponsors and CROs to use next day delivery or even priority) could be $15-$20. Is $27,000 - $54,000 justified when esignatures would all but nullify this cost? There are over 90,000 active trials listed on clinicaltrials.gov. Allowing for the fact that many of these studies such as phase I studies, may involve a low number of sites, and others, such as phase IV or registry studies may involve 100's or 1,000's of sites a reasonable average number of sites per study may be around 25 (a low average, I believe). Shipping of documents for the sole purpose of execution in pharmaceutical clinical research can cost between $160,000,000 and $300,000,000. And this does not account for studies conducted overseas. I fully understand the importance of security within this realm; however, as you pointed out, esignatures are safe and secure. I also realize how slow pharma is to adopt new technology, but it seems that at this point it is the responsibility of the industry to make this simple adoption to bring greater efficiency to the process of clinical research, drastically reducing the cost, without any potential adverse effects on study quality or patient safety. Thanks again, Dan Manak Sr Director of BD at goBalto Matt and Macy,
Thank you for this post, it is very informative and you bring up many relevant points. I used to manage an SMO (Site Management Organization) and processed about a hundred site start-ups per year. Study start-up in clinical research is a very paper heavy process and the shipping of documents boarders on extreme. I am glad that you mentioned the use of esignatures specifically within pharmaceutical FDA regulatory requirements. In my opinion, the use of esignatures is extremely underutilized in both: the regulatory and contracting process involved in study start-up.

The financial implications of the industry adopting esignatures as the norm is staggering. As an example look at a phase III trial involving 300 US sites. The minimum number of instances in activating a research site when esignatures could be employed is 3: assuming the regulatory pack can be settled with one exchange between sponsor and site, 1 contract + 1 contract amendment. For each instance there will be 3 shipments (sponsor to site for site signature, site to sponsor for full execution, and back to site for filing). The average cost for shipping (it is standard for pharma sponsors and CROs to use next day delivery or even priority) could be $15-$20. Is $27,000 – $54,000 justified when esignatures would all but nullify this cost? There are over 90,000 active trials listed on clinicaltrials.gov.

Allowing for the fact that many of these studies such as phase I studies, may involve a low number of sites, and others, such as phase IV or registry studies may involve 100′s or 1,000′s of sites a reasonable average number of sites per study may be around 25 (a low average, I believe). Shipping of documents for the sole purpose of execution in pharmaceutical clinical research can cost between $160,000,000 and $300,000,000. And this does not account for studies conducted overseas.

I fully understand the importance of security within this realm; however, as you pointed out, esignatures are safe and secure. I also realize how slow pharma is to adopt new technology, but it seems that at this point it is the responsibility of the industry to make this simple adoption to bring greater efficiency to the process of clinical research, drastically reducing the cost, without any potential adverse effects on study quality or patient safety.

Thanks again,

Dan Manak
Sr Director of BD at goBalto

]]> By: Ashley Miller http://alphatechcounsel.com/blog/2010/wide-adoption-of-electronic-signatures-and-electronic-contracts-overdue/#comment-81 Ashley Miller Tue, 08 Jun 2010 15:35:18 +0000 http://alphatechcounsel.com/blog/?p=318#comment-81 In case anyone is interested in learning about how companies use and benefit from digital signatures, my company, ARX (mentioned above) published a short eBook on SlideShare called "Think Twice Before You Sign Anything Again" that includes 12 accounts of real-life companies who have implemented digital signatures. It also provides tips to keep in mind when looking for the most appropriate digital signature solution for your company. The eBook can be found at http://www.slideshare.net/digitalsignature/digital-signature-ebook-think-twice-before-you-sign-anything-again Thanks! In case anyone is interested in learning about how companies use and benefit from digital signatures, my company, ARX (mentioned above) published a short eBook on SlideShare called “Think Twice Before You Sign Anything Again” that includes 12 accounts of real-life companies who have implemented digital signatures. It also provides tips to keep in mind when looking for the most appropriate digital signature solution for your company.

The eBook can be found at http://www.slideshare.net/digitalsignature/digital-signature-ebook-think-twice-before-you-sign-anything-again

Thanks!

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