Digital Signatures Provide Competitive Advantage for Top 10 CROs

CoSign® digital signature solution automates your approvals affordably

Clinical Research Organizations (CROs) accelerate investigator site initiation, expedite clinical reporting, and support GxP audits more efficiently with digital signatures.

Defense News: SAN FRANCISCO--(BUSINESS WIRE)--Clinical Research Organizations are part of a highly collaborative clinical trial ecosystem that demands efficiently-controlled quality and compliance documentation. It is mission critical for CROs to create, control and share documentation internally and externally in a trusted manner. In order to achieve this and to simplify and expedite business processes, many CROs have adopted e-clinical software solutions, form authoring tools, electronic workflow systems, and quality/document management systems. However, the need to reintroduce paper often arises when a signature or approval is required, thus creating an automation gap that hinders efficiency, restricts collaboration, and reduces the ROI of these business automation tools.

To close the automation gap created by the need to obtain approvals, many CROs have deployed a digital signature solution and are now enjoying reduced costs, expedited processes, and greater value in their services to sponsors by going fully paperless.

Digital signatures significantly reduce the time it takes for CROs to approve and sign documentation. In addition, they eliminate the hard costs associated with printing, copying, and routing paper-based documentation. The elimination of paper-based costs can save hundreds of thousands of dollars annually for even small- to mid-sized CROs. Further, digital signatures eliminate the time lags associated with paper-based approvals and submissions, while enhancing integrity and reducing the compliance burdens of controlled documents.

Consider the tangible benefits of digital signatures seen by some CROs in a variety of enterprise-wide applications, departments, and common business processes:

Signing of site Monitoring Trip Reports by Clinical Research Associates (CRAs) – Digital signatures allow CRAs and clinical project managers to sign and submit reports back to sponsors within tight contract terms and eliminate the substantial time and costs related to paper-based reporting. One top 10 CRO estimates savings of nearly $1 million per year in priority mailing costs alone from the use of digital signatures.

Speeding up the on-boarding and initiation of clinical sites – As part of an Investigator Portal, investigators and institutional review boards (IRB) can digitally sign regulatory documents (1572s, CVs, protocols, informed consents, IRB approvals, trial agreements, etc.) via a web browser, accelerating site/study initiation void of the expensive and time-consuming restraints associated with paper-based approvals. Digitally signed documentation allows easy submission to study sponsors in a format that enables electronic submissions to regulatory authorities.

Signing quality and compliance documents used to support FDA, EMEA and Vendor Audits – Quality controlled documents being signed include SOPs, work instructions, training records, and project/task-specific documentation. Sometimes, this requires integration of the digital signature technology with an electronic document management and workflow system such as Microsoft® SharePoint®, or other EDM system.

Six of the top 10 CROs use CoSign® digital signatures

The ARX CoSign digital signature system is being used by 6 of the top 10 CROs today: PRA International, PPD, CRL, Kendle International Inc., PAREXEL International, and PharmaNet, and over 25 CROs altogether. Users include over 10,000 clinical research associates and over 10,000 investigator sites and IRBs. With CoSign, top CROs are ensuring compliance, expediting processes, saving time and hard costs, and gaining a competitive advantage.

To learn more about what CoSign can do for you, read more about CoSign digital signatures for CROs.

About CoSign Digital Signatures in Life Sciences

ARX’s CoSign digital signature solution is standards-based (PKI) electronic signature technology. CoSign 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 nearly 30 CROs, in over 10,000 investigator sites and IRBs and by leading sponsor organizations. Via its standards-based underpinnings, the CoSign digital signature solution ensures signer identity and intent, document integrity and regulatory compliance in a non-proprietary manner for any receiving party to easily verify and validate. Watch a Digital Signatures for Life Sciences video to learn how life sciences organizations can benefit from CoSign.

About The Digital Signature Company - ARX

ARX (Algorithmic Research) is a global provider of cost-efficient digital signature solutions for industries such as life sciences, healthcare, government, engineering, etc. ARX engineers and scientists have more than 20 years of experience in security and standard digital signature application. ARX helps businesses secure, streamline, and scale their processes and transactions with the proper controls required by legislation, regulation, and industry best practice. Learn more about ARX and the CoSign digital signature solution.

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

Contact:

ARX
Ashley Miller, (415) 839 8161
Ashley@arx.com