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 world’s leading clinical research organizations, SCRI runs 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,” the director of application services 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 the solution.”
Process Delays Cause Frustration
SCRI found that the many signatures required to authorize and track clinical trials significantly delayed launching a new drug or medical process. It took between 19 and 58 days to get a single document signed. 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,”the director of application services said.
Any e-signature system SCRI chose had to adhere to the Food and Drug Administration’s 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.
Compliant E-Signatures Offer a Solution
SCRI contacted several e-signature vendors in his search to find the right solution for SCRI’s unique needs and found that none offered the advantages provided by SIGNiX. He and his SCRI team chose SIGNiX because:
- SIGNiX’s independent e-signature technology met SCRI’s need for a highly secure, easily validated e-signature.
- SIGNiX’s adherence to international published standards assured that SCRI would be able to use SIGNiX’s system anywhere in the world and that SCRI would not be dependent on proprietary technology, which has no guarantee of longevity.
- SIGNiX’s system was much more flexible than other vendors, so that it could be customized to SCRI’s specific needs.
- SIGNiX’s 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 SCRI’s 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,”the director of application services said. “The introduction of SIGNiX’s 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.”