The Most Widely Used Solution in the Life Sciences
“CoSign provides an elegant solution for both our business and regulatory requirements.”
– Dr Jonathan Engler, former Joint MD, ClinPhone Group Ltd.
The CoSign digital signature solution has over 90% market share in the life sciences industry, with thousands of deployments in FDA-regulated organizations. The solution is being used today by:
- 14 of the top 15 pharmaceutical companies
- 9 of the top 10 clinical research organizations
- 11 of the top 15 medical device companies
- Many of the leading academic CROs
- Numerous government research agencies in the US and abroad (including the US Department of Health & Human Services)
- Many of the world’s largest technology, service and SaaS vendors supporting R&D, clinical research and manufacturing operations
These market leaders chose CoSign because it is the only digital solution that provides all of the following benefits:
- Compliance – CoSign is 100% based on international standards technology complying with strict industry requirements including the FDA’s 21 CFR Part 11, GxP audits, NIST, HIPAA, SOX, and ISO. CoSign has been used to create digitally signed electronic records that have supported over 5,000 FDA audits as well as numerous electronic submissions to the FDA and other regulatory authorities. Learn more about digital signature compliance.
- Choice – CoSign is a flexible digital signature engine that easily integrates into any automation system, application and technology that fits your specific needs. It can also be used with all major content authoring applications and file types. It offers out-of-the-box support for major desktop authoring tools such as Microsoft Office and PDF, as well as popular document management solutions such as SharePoint.
- Control – CoSign enables control by adapting to your policies, procedures and complementary technologies—not the other way around. This gives you the freedom to manage your use of digital signatures in whatever ways best fit your organizational governance and SOPs. For example, CoSign readily integrates with your organization’s HR, IT Security, Customer and Supplier Screening policies, as well as the user-provisioning and user-management systems you already have in place.
- Cost-effectiveness – CoSign is typically 5-25% of the cost of alternative digital signature solutions. A good reference point is an Applied Clinical Trials magazine article which includes a detailed analysis of the costs of various digital signature-based solutions including CoSign.
Clinical Research Organizations (CROs) have chosen CoSign because documents signed with CoSign are secure source electronic records that are portable, self-contained, and compliant with worldwide regulations. As such, they are trusted and recognized by sponsor organizations and regulatory authorities. With CoSign, CROs expedite site and study initiation while lowering site on-boarding costs and facilitating the sponsor’s desire for electronic regulatory submissions. Learn about CoSign for CROs.
CoSign has been deployed in numerous eClinical portals (CTMS, Investigator Portals and Trial Master Files) to enable secure and compliant paperless processes through the signature approval phase and for obtaining signatures from parties within and outside of the organization. Learn about CoSign for eClinical portals.