Introducing a New E-Signature Product for the Life Sciences Community

We’re happy to announce that this week we launched PharmaDoX—the pharmaceutical industry’s first digital signature service created specifically to relieve the paperwork burdens of clinical trials. With PharmaDoX, it’s easy for sponsors, clinical research organizations (CROs), patients and investigators to sign clinical trial documents. This ready-made solution incorporates all the requirements of the FDA’s 21 CFR Part 11 rule by default.  

“Clinical trials and FDA submissions have suffered from paperwork burdens for a long time,” said Jessi Lanuza, SIGNiX’s business development executive for the life sciences industry. “With the PharmaDoX e-signature service, life sciences organizations can enjoy the benefits of going paperless while also complying with FDA regulations.”

One CRO who was an early adopter of PharmaDoX has implemented e-signatures on:

• Protocol signature pages
• FDA Form 1572 signatures
• Financial disclosures
• Delegation of authority forms
• CV signatures
• Protocol training acknowledgments

This CRO saves 1.2 million dollars annually on courier charges alone by adopting PharmaDoX. Additionally, the CRO has reduced study start-up times, nearly eliminated document re-routing and has increased investigator satisfaction. 

We worked closely with different companies in the life sciences community to develop PharmaDoX specifically to meet the needs of sponsors and investigators. Complying with 21 CFR Part 11 requires specific workflows with extra security around the authentication and signing processes that few e-signature services can provide. PharmaDoX incorporates all of the compliance protocols behind the scenes, making sure every signature is compliant without any extra effort on the part of thefor signers. Additionally, we understood that not all life sciences documents require the same level of compliance. That’s why we made the 21 CFR Part 11 compliance feature easy to turn on or off.

Because life sciences companies are often global businesses, their digital signature service must meet legal requirements for many different countries. PharmaDoX provides an e-signature service that meets the FDA’s regulations in the United States, the European Medicines Agency in the European Union and e-signature requirements around the world.

Interested in getting PharmaDoX for your life sciences company? Get a price quote today!