SIGNiX
Independent, Evidence-based Digital Signature Solutions for the Life Sciences

Time is money in the life sciences industry. On average, the capitalized cost of a clinical trial is about $1.3 billion according to the Tufts Center for the Study of Drug Development, which can equate to as much as $1 million a day. With the ability to dramatically expedite the process of the all-important First Patient In (FPI) date at clinical research and site management organizations in the U.S., electronic signatures have become the defining, proven method for decreasing the time and cost of clinic trails. But the benefits of electronic signatures to the life sciences industry are not limited to the impact on clinical trials.

Other benefits include efficiency, cost reduction and enhanced data management, attributes that are important to any life sciences company. However, it can be challenging to provide the high level of security required in life sciences while also making the e-signature process easy to use. In the past, life sciences companies have had to use piecemeal solutions to signing – employing basic, less secure e-signature methods in areas where security was not vital and leaving regulated workflows to wet ink or complex technology. Yet, one digital signature company, SIGNiX, Inc., has challenged the statusquo. SIGNiX’s scalable, cost-effective solution is applicable across the entire security spectrum of transactions within life sciences, while retaining the ease-of use necessary for broad adoption. SIGNiX’s exceptional suitability to highly regulated verticals like pharma and life sciences is rooted in its ability to create and maintain legal evidence that is independent of SIGNiX.

The comprehensive audit trail attached to SIGNiX e-signatures provides independently verifiable evidence of the intent to sign along with information about when documents are viewed, when users are authenticated and more. Further, all documents and all versions of the documents are tamper evident. “Because the evidence backing a SIGNiX e-signature is embedded in the signed document, with no need to link back to SIGNiX, there is no expiration date on the e-signature. It can be validated in five, 10, 25 years or more,” said Jay Jumper, President and CEO of SIGNiX.

Other e-signature vendors’ clients must link back to the vendor’s technology for e-signature verification. So, if the vendor goes out of business (or even if a client ends its contract with the vendor), clients lose proof that their e-signatures are valid. SIGNiX also offers a variety of online signature products to fit an organization’s needs. MyDoX offers a safe, simple signing solution for basic transactions, while the Pharma DoX solution takes this robust digital signature infrastructure and places it in a 21 CFR Part 11-compliantworkflow. PharmaDoX automatically logs all information required by the FDA, eliminating any possible errors in complying with FDA regulation 21 CFR Part 11.

We offer a digital signature that is fully independent and meets U.S. and international regulations for FDA and EMA compliance

It also offers the option to insert a "qualified digital certificate," including a SAFE-BioPharma credential, for additional protection. The result of using this secure, compliant interface to expedite e-signatures can save hundreds of thousands of dollars in courier and paper costs, eliminate excessive resources, and reduce storage needs and delays in finalizing transactions.

Consider the results from Sarah Cannon Research Institute, which chose SIGNiX to speed up clinical trials by enabling doctors to sign regulatory forms electronically and receive automated reminders to accelerate the signing process. By switching to SIGNiX, the research institute eliminated the need to ship at least 40,000 documents each year using next-day mail, resulting in dramatic savings in time and money. “Our success is tied to the superiority of our e-signature solutions. The market for e-signatures is growing, and independent, evidence-based security will be the most important criteria in life sciences in e-signing in the future,” Jumper concluded.