CoSign Digital Signatures Accelerate Clinical Site Initiation and Compliance

SAN FRANCISCO - (BUSINESS WIRE) - ARX, Inc., the leading provider of digital signature solutions has partnered with Entralogix Systems Inc., the market leading provider of clinical software solutions for life sciences organizations. ARX's CoSign digital signature solution is combined with Entralogix eStudy Binder enabling end-users to keep clinical trial documentation electronic throughout the entire lifecycle - from conception to FDA submission.

Sponsors around the world are adopting e-Clinical technologies with the aim of improving operational efficiency in clinical trials and speeding up site and study initiation. To meet this need, eStudy Binder offers a comprehensive, regulatory electronic Trial Master File (eTMF) system fully integrated with electronic Investigator Site Files (eLSF), which enables end-users from the site and study levels to compliantly and electronically maintain all trial-related documentation in a secure online portal. With integrated digital signatures, clinical sites and IRBs using eStudy Binder can securely and compliantly authorize trial documentation without the need for printing, ink signing, routing, and manually archiving paper documents.

"The combined solution enables clinical trial professionals to fully automate the regulatory workflow and enjoy dramatically reduced study start-up times, in addition to measurable cost savings," explains Dr. Vito Losito, CEO and Director of Clinical Trials, Entralogix. "In addition, they're able to monitor site and study progress and significant milestones (such as completion of all regulatory packet documents), and also maintain trial-related communication in an internal, study-specific messaging center."

CoSign's proven track record within FDA Title 21 CFR part 11 compliant processes is a major factor in its adoption with eStudy Binder, as CoSign enables compliant e-submissions that regulatory authorities prefer. Without digital signature capability, the automated processes enabled by eStudy Binder would be halted by the need to re-introduce paper into the workflow for the purpose of obtaining signature approvals. Now, clinical trial professionals can keep site and study initiation moving smoothly through every stage of the workflow.

"More and more CROs and study sponsors are demanding that clinical sites have the ability to be initiated and monitored using fully electronic processes, and include digitally signed documentation," explains Rodd Schlerf, FDA and USDA Markets Manager, ARX. "We're excited to contribute to the success of our SaaS partners by closing the final gap to automation through digital approvals."

About Entralogix Group Inc.

Entralogix Group Inc., through its wholly owned subsidiary, Entralogix Systems Inc. provides integrated electronic Trial Master File (eTMF), Investigator Site File (eISF) and document workflow solutions that are designed to enable life science companies of all types and sizes to automate and integrate the management of their entire clinical development process. Entralogix Group Inc. has been conducting clinical trials since 2004 through a multispecialty community-based physician consortium for sponsors of all sizes.

Visit us on the Web: www.entralogix.com

eStudyBinder is a registered trademark of Entralogix Systems Inc.

About CoSign Digital Signatures in Life Sciences

ARX (Algorithmic Research) is a global provider of cost-efficient digital signature solutions for industries such as life sciences, healthcare, government, engineering, and energy. ARX's CoSign digital signature solution fully automates approval workflows, allowing organizations to go paperless, expedite business processes, and eliminate the expenses and time allocations that paper-based signatures require. CoSign is the most widely-deployed digital signature solution in the Life Sciences industry, employed by over 10,000 FDA-regulated organizations including 5 of the top 10 Pharmaceuticals and 4 of the top 10 CROs. Via its standards-based underpinnings, the CoSign digital signature solution ensures signer intent, document integrity and compliance, while significantly streamlining business processes. CoSign creates a truly collaborative environment for the multiple parties involved in the Life Sciences ecosystem, enabling trust of electronic documentation spanning geographic locations and across organizations. Watch a Digital Signatures for Life Sciences video to learn how life sciences organizations can benefit from CoSign.

CoSign is a registered trademark of Algorithmic Research, Ltd. All other trade names and trademarks are the property of their respective holders.

Suggested Articles

Xcovery's ALK inhibitor shrank tumors in 75% of lung cancer patients, compared to 67% for Pfizer's Xalkori, the first FDA-approved drug of that class.

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.