Digital Signatures within Investigator Portals Accelerate Clinical Processes

San Francisco, California, May 12, 2010

Clinical trial stakeholders, including Clinical Research Organizations (CROs) and study sponsors, are part of a collaborative ecosystem that demands signing of documentation, secure document exchange, and submission of forms during the course of clinical trials. To better execute these processes, CROs and sponsors have adopted web-based investigator portals, or clinical trial management systems (CTMS) to enable all stakeholders including sponsors, CROs, clinical investigators, and institutional review boards (IRBs) to collaborate in the most effective and timely manner possible. Complementing this effort, the use of digital signatures has become a key component to enabling the quick on-boarding of investigator sites, and adding security and efficiency in the exchange of trial master documentation.

ARX’s CoSign® digital signature solution enables the various participants in a clinical ecosystem to sign off on regulatory packet documents (including 1572s, CVs, protocols, informed consents, IRB approvals, trial agreements, and more) from within the online web-portal, thereby eliminating the need for printing or priority mailing paper documents. By enabling these collaborators to digitally sign and approve forms, agreements and other documents with CoSign, sponsors and CROs expedite site and study initiation while lowering the costs to commence and continue site activities. CoSign also facilitates the sponsor’s desire for electronic regulatory submissions. Furthermore, with CoSign standard digital signatures, any third party recipient can trust and verify the signed e-record without the need for proprietary software or further access to the system.

Use of CoSign digital signatures in Life Sciences has grown to include 6 of the top 10 CROs today: PRA International, PPD, CRL, Kendle International Inc., PAREXEL International, and PharmaNet, and over 25 CROs altogether. One top 10 CRO uses CoSign within a SharePoint-based investigator portal hosted for the participants in their clinical trials, which include over 6000 external clinical investigator sites, IRBs and study sponsors (pharmaceutical companies).

40% of the top 25 BioPharmaceutical companies also have CoSign installed today. Three of these companies are using CoSign for large-scale investigator portals hosted for thousands of external collaborators who are signing off trial master folder, or study binder documentation.  In addition, several other top 25 BioPharmaceutical companies are using CoSign through a 3rd party investigator portal SaaS.

In the growing Investigator Portal market, there are many software vendors and SaaS providers that offer a packaged solution for CROs and sponsors. Leading suppliers like NextDocs, ePharma Solutions, EntraLogix, Perceptive Informatics (PAREXEL), and InnovoCommerce have all integrated CoSign with their Investigator Portal software or SaaS offerings.

Learn more about digital signatures within Investigator Portals.

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 20,000 FDA-regulated organizations including 9 of the top 10 Pharmaceuticals and 6 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.

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

Press Contact:
Ashley Miller
ARX
(415) 839 8161
Ashley@arx.com