SIGNiX Case Study, HCA Healthcare, Inc.'s Sarah Cannon Research Institute
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Sarah Cannon Research Institute (SCRI) wanted to improve the speed and efficiency of launching clinical trials. After piloting the SIGNiX e-signature service, SCRI reduced the time to sign clinical trial documents from 19-58 days to just 3-4 days. SCRI also expects to save $250,000 in the first year alone on costs like printing, postage, and storing paper documents. The SIGNiX solution met SCRI's requirements for security, flexibility, customization, and ease of use across different devices and locations.
SIGNiX Case Study, HCA Healthcare, Inc.'s Sarah Cannon Research Institute
- 1. Clinical Research Organization Accelerates Trials with SIGNiX SIGNiX Customer Success Story Sarah Cannon Research Institute (SCRI) wanted to improve the speed and efficiency with which it launched clinical trials. After piloting SIGNiXs e-signature service, SCRI reduced from 19 58 days to 3 4 days the time required to sign clinical trial documents. It also expects to save $250,000 the first year alone on the cost of printing, postage and storing paper documents. Situation Peyton Hale, the director of application services for Sarah Cannon Research Institute, was charged with improving the speed and efficiency by which SCRI launches clinical trials. As one of the worlds leading clinical research organizations, SCRI typically runs approximately 500 clinical trials per year, many of them being critical first-in-human trials. This huge workload combined with exacting FDA regulations on new drugs and stringent security requirements made it difficult for SCRI to quickly get to market the life saving therapies it develops and tests. Speed-to-market is a key determinant of success in the life sciences industry, Hale said. We were looking for every way to streamline our processes that would expedite our trials, as well as save money that we could allocate toward our research. We discovered that something as simple as revamping physician signature protocol could be thesolution. Hale found that the many signatures required to authorize and SIGNiwww.signix.com | 1110 Market Street, Suite 402 | Chattanooga, TN 37402 | 877.890.5350 x1057 About Sarah cannon research institute Location: Nashville, TN Active Trials/Year: 500+ First-In-Human Trials: 150+ Physician Network: 1,000+ Sarah Cannon Research Institute (SCRI) has one of the largest clinical research programs in the world, conducting community-based clinical trials in oncology, cardiology and orthopedics in the United States and United Kingdom. SCRI uniquely focuses not only on serving the drug development industry and other principal investigators, but also on developing its own innovative SCRI-sponsored research. It played a role in the development of 80% of the oncology drugs approved between 2012 and 2014.
- 2. track clinical trials significantly delayed launching a new drug or medical process. It took between 19 and 58 days to get a single documentsigned. Several factors contributed to this delay, including: Time required to ship physical documents File size issues in emailing documents Signers not having access to a printer and scanner Existence of multiple originals for documents requiring multiple approvals Resending lost documents, especially when third parties were involved Signers being out of office Having to collect, reconcile and store signed documents In addition to slowing down clinical trials, the use of ink signatures on paper added significant expenses, including: Storage and archiving costs for paper originals (25 years in Canada, up to 99 years in the EU and the U.S.) Courier and overnight delivery costs Printing and paper costs The obvious solution was to replace ink signatures with electronic signatures, but in such a highly-regulated industry, transitioning to digital processes requires above-average attention to security, compliance and overall execution, Hale said. Any e-signature system Hale and his colleagues chose had to adhere to the Food and Drug Administrations strict protocols for electronic records, outlined in Title 21 CFR Part 11 of the Code of Federal Regulations. Furthermore, because SCRI has a global reach and works with more than 1,000 physicians, the e-signature system must meet the requirements of many different countries. Solution Hale contacted several e-signature vendors in his search to find the right solution for SCRIs unique needs and found that Obstacles Highly regulated industry Extremely complex, multi-layered workflows, involving people spread across the globe Speed-to-market is a key to success Existing signature process slowed the clinical trials process significantly Wet ink signature system imposed significant expenses that were not mission-critical Sarah Cannon Research Institute employees flaunt the amount of paper saved during the first three months of using e-signatures. SIGNiwww.signix.com | 1110 Market Street, Suite 402 | Chattanooga, TN 37402 | 877.890.5350 x1057
- 3. none offered the advantages provided by SIGNiX. He and his SCRI team chose SIGNiX because: SIGNiXs independent e-signature technology met SCRIs need for a highly secure, easily validated e-signature. SIGNiXs adherence to international published standards assured that SCRI would be able to use SIGNiXs system anywhere in the world and that SCRI would not be dependent on proprietary technology, which has no guarantee of longevity. SIGNiXs system was much more flexible than other vendors, so that it could be customized to SCRIs specific needs. SIGNiXs exemplary customer service assured that the setup and integration of the new e-signature system would run smoothly. SIGNiX was the only e-signature vendor that SCRI vetted that met all of SCRIs critical requirements. SIGNiX is fantastic to work with. We presented them with a complex situation and high expectations and they met them without fail. They also kept us in the loop throughout, and if I called them with a question, I always got an answer within a matter of hours, if not immediately, Hale said. The introduction of SIGNiXs system to the physicians who run our trials has gone very well, and we are now working on a workflow to obtain patient signatures, plus our legal department is looking at other ways we can use SIGNiX technology to enhance our operations. It has been a great success. Features Independent eSignature solution met clients need for document longevity, transparency and control a standard that dependent vendors could not meet Tamper-proof documents, not just tamper-resistant Most trusted level of authentication Able to integrate with SCRI systems through flexible APIs Access through multiple devices (tablets, cell phones, etc.) Simple user interface to guide signers Radio buttons, which require signers to select one of a set of predetermined options before the transaction process can move forward to improve efficiency Very cost-effective solution with a compelling ROI Ability for client to independently control existence of signed documents, such as keeping them all on client servers, and none on SIGNiX servers 94% reduction in time required to sign documents, greatly enhancing speed-to-market Projected $250 thousand in first-year savings in printing and delivery costs Eliminated need for new space to store ever-increasing paper files Enhanced security over ink signature system; fully compliant with FDA 21 CFR Part 11 regulations for electronic signatures and records Ease of use encourages quick adoption Works with many different IT systems Benefits SIGNiwww.signix.com | 1110 Market Street, Suite 402 | Chattanooga, TN 37402 | 877.890.5350 x1057
- 4. Meet FDA security protocols set forth in federal regulation Title 21 CFR Part 11. SIGNiXs unique independent, SaaS-based PharmaDoX product is compliant with 21 CFR Part 11. (We take security seriously.) Verify validity of e-signatures independent of the e-signature vendor. SIGNiX embeds the evidence behind each e-signature within the signed document, and it is therefore independently verifiable, even without an Internet connection. SIGNiX is also a Registration Authority, allowing it to provision and issue digital certificates independent of a third party. Make e-signed documents tamper-proof, not just tamper-evident. SIGNiX customized its solution so that documents could not be modified once signed, overriding traditional tamper-evident technology that allows and identifies changes to the document. Provide operability across a broad range of platforms and international standards. SIGNiX is based on internationally recognized, published standards that assure interoperability between any platform and the long-term validity of e-signature evidence. Speed up the signing process. SIGNiXs system reduced the signing timespan from 19 - 58 days to 3 - 4 days. Customize the e-signature solution to meet SCRIs unique requirements. SIGNiX has always developed its platform to meet the needs of its customers and continues to work on feature enhancements for SCRI even today. Allow signers to sign documents from anywhere in the world. SIGNiXs e-signature service is cloud-based and can be accessed by any device with an Internet connection. Its responsive interface allows signers to use virtually any device, including smartphones and tablets. Cut expenses that are not mission-critical. SCRI expects to save $250,000 during the first year and predicts it will save over $500,000 annually using SIGNiX when fully implemented across the enterprise. E-signature vendor must pass a rigorous, on-site security audit of the entire company, from operations to software architecture to maintenance, and everything in between. SIGNiX follows strict Standard Operating Procedures for software development and life cycle management. SIGNiX passed SCRIs comprehensive audit with a clean report. NEED SOLUTION SIGNiwww.signix.com | 1110 Market Street, Suite 402 | Chattanooga, TN 37402 | 877.890.5350 x1057