CoSign Digital Signatures for CROs

Clinical Research Organizations (CROs) are in the middle of a highly collaborative ecosystem where both internally generated and investigator site generated documentation needs to be securely exchanged with study sponsors and later submitted to regulatory authorities. A huge portion of this documentation needs to be signed and is regulated under 21 CFR Part 11 and GxP practices. All of this documentation needs to be secure and trusted throughout the various parties in the clinical research ecosystem.

In a paper-based world, completion and submission of the approved and signed documents can be achieved only by slow, inefficient, and costly manners which, ultimately, are not in the electronic format that clients prefer.

Digital signatures enable CROs to go paperless and create secure source electronic records that can be trusted by any organization that needs to verify the identity and intent of the signing party, and guarantee the authenticity (data integrity) of the record content today or years into the future. Digitally signed electronic records are portable, self-contained, sustainable, and legally compliant with worldwide regulations; as a result, they provide legally enforceable electronic records that are recognized by sponsor organizations and regulatory authorities.  Organizations that implement digital signatures benefit from expedited business processes and significant cost reduction while maintaining legal and regulatory compliance. 

• Quality and Compliance documents used to support FDA, EMEA and vendor audits in quality, R&D, clinical, lab and manufacturing operations. This includes SOPs, work instructions, validation and test procedures, training records, and project or task specific documentation that may be called into an audit to substantiate adherence to SOPs.
  Over the past 5 years, electronic records digitally signed by CoSign have supported several thousand FDA, EMEA, HACCP, USDA, HIPAA and SOX audits and many of our clients regularly perform electronic submissions to regulatory authorities.
  Use of CoSign for quality and compliance documents may also involve seamless integration with Electronic Document Management (EDM) and workflow systems like Microsoft® SharePoint® and others. However, unlike proprietary electronic signatures that some EDMs may have supported in the past, CoSign enables the digitally signed electronic records to be validated and trusted outside of the repository, or even outside of the organization as in a common requirement for a CRO.
  Click here to learn more about Digital Signatures for Document Management. 
• Site Monitoring Trip Reports and other field- or site-generated reports generated by Clinical Research Associates (CRAs) and project managers.  Eliminating paper from the reporting process allows CRAs and project managers to meet sponsors’ tight submission deadlines while saving thousands of dollars annually.
  Some CROs have saved over ½ million dollars annually in priority mailing costs alone by using CoSign for this single application, and over 10,000 CRAs and clinical project managers are using CoSign today for this purpose.
• Web-based Investigator Portals (i.e. CTMS, study binders, trial master folders, etc.) which enables external collaborators such as investigators, IRBs, coordinators, labs and sponsors to sign regulatory packet documents and forms including 1572s, protocols, informed consents, IRB approvals, CVs, trial agreements, and other common forms.

The ARX CoSign digital signature product is the largest and most widely deployed digital signature solution being used today in thousands of FDA, EMEA, USDA and HIPAA regulated applications.  CoSign has an estimated 80% of the digital signature market in FDA regulated industries, including:

• 6 of the top 10 CROs and over 35 CROs throughout  the world 
• Over 10,000 CRAs 
• Over 10,000 investigator sites and IRBs 
• 8 of the top 10 BioPharmas
• 4 of the top 10 Medical Device companies
• Over 50 central labs

In addition, many of the clinical software suppliers and SaaS vendors use CoSign both internally and as an imbedded technology as part of their solution offerings.

• Decreased Costs. Including people’s time as well as the hard costs of paper processes: paper, printing, copying, signing, scanning, routing, faxing, mailing, microfilming, indexing, storing, shredding, etc.
• Increased Efficiencies. CoSign accelerates the pace of approvals particularly for documents requiring multiple signatures across multiple geographies and/or organizations.
• Regulatory Compliance. In SOX, HIPAA, EMEA and FDA regulatory, quality and compliance applications, CoSign enables audits to be conducted electronically – quicker, more securely, and at a lower cost.  Regulatory authorities also recognize digital signatures for e-submissions.
• Increased Collaboration. CoSign bridges geographic, technical, and corporate boundaries, enabling electronic submissions and secure document exchange with outside parties such as government agencies, clients, suppliers, partners, etc. throughout an extended value chain or ecosystem.

Read more about the digital signature business case for the Life Sciences industry.