Bringing new drugs to market requires validated processes for reporting clinical trial results. The S-doc™ system speeds the distribution of data by allowing it to be securely disseminated over the Internet. It lets authorized staff and remote affiliated personnel and clinical research organizations safely send, receive, store and access sensitive information, using any computer with a standard web browser.

Clinical trial information, messages, patient files — all of it is kept private and secure from the point of origin to the point of delivery. An encrypted copy is automatically kept on the S-doc Securit-e-Vault™ server. And a detailed audit log is generated for every transaction, in full compliance with all government regulations.

The S-doc™ system is as easy to use as e-mail. It requires no client-side software, no keys to manage and no tokens to carry. The technologies involved remain invisible to the user, yet leverage state-of-the-art encryption and the best possible protection processes available.

• Allows secure communication and secure point-to-point transport of sensitive product and clinical trial information to:
  — authorized staff and faculty
  — clinical research organizations
• Provides secure storage for EMR (electronic medical records) created in any application or file format
• Generates automatic, unalterable audit trail for all transactions including unauthorized access attempts
• Cost-effective solution to move clinical trial information securely between authorized originators and intended recipients without private networks

• Already in use in multiple government agencies for secure communication, secure messaging and transfer of protected files and documents between trusted partners
• In use by public and private organizations worldwide addressing internal/external fraud and regulatory compliance
• NIST validated cryptosystem, with FIPS-140 compliance and fully certified encryption algorithms
• U.S. Patent No. 6,665,709 for S-doc’s unique secure Internet communication and data storage technology

The S-doc™ system helps pharma and life science organizations comply with the following:

• 21 CFR 50, Part 11
• HIPAA privacy and security rules
• California Privacy Act SB 1386
• Sarbanes-Oxley