SureEsign™ High Trust Digital Signing for Health Sciences

Are you overwhelmed with paper? Spending too much time and money on scanning documents? Missing important documents?

Often, automating document completion processes with digital signing at the point of origin can can eliminate costly paper handling processes. When used with automated workflows, digital document signing using verifiable digital signatures can minimize costly paper handling processes, and can often provide a strong return on investment based on savings in overnight mail fees alone.

SureEsign™ is a cloud-based digital signing service that provides verifiable digital signatures on any clinical trial document or medical image. As compared with simple electronic signatures, SureEsign uses highly-trusted US Government compliant level 3 digital signing certificates securely embedded in PDF documents. The SureEsign high-trust digital signing certificates can be independently verified by any third party recipient using SureViewer™, Adobe Reader or Adobe Acrobat. A complete audit trail of all signing transactions is easily viewed and exported from within the SureClinical eTMF cloud application.

SureEsign™ is integrated within the SureTrial application, and a library of predefined workflows and processes helps you implement most SOPs for automated eTMF clinical trial document capture and signing. SureEsign’s integrated signing policies and document integrity enforcement are designed to support US and EU EMA digital signature regulations.

As a result of these integrated document integrity policies, users can expect enhanced document quality and integrity, lower risk from fraudulent documents, and higher levels of government agency compliance. Incorporating an integrated FDA compliant digital signature audit trail, multi-factor authentication and an independent x.509 PKI high-trust certificate authority validation path for every signature, SureEsign™ gives you the confidence that your digitally signed documents are signed by the correct party and that they have not been tampered with after signing. All documents can be validated within SureClinical eTMF or in popular applications such as Adobe Acrobat or Adobe Reader. SureEsign™ supports digital signing of essential clinical trial documents or medical images in clinical trials, and can be implemented for any or all members of the clinical trial study team. SureEsign™ – FDA and EU EMA compliant verifiable digital signatures.


  • Verifiable high-trust digital signatures using X.509 government compliant certificates
  • Integrated secure digital signing from desktop or mobile devices
  • Military-grade security with NIST-approved FIPS-140-2 Level 3 PKI storage
  • Secure multi-factor authentication for signer ID verification
  • Complete unalterable audit trail for all signing events
  • Integrate with existing applications with the SureEsign Certified Platform
  • View and verify signatures in SureViewer™, Adobe Reader™ or Adobe Acrobat™
  • Independently audited for FDA 21 CFR Part 11 Compliance


  • Accelerate study startup time with digital signing of essential documents
  • Lower risk and enhance compliance with automated required document capture
  • Enable higher productivity with automated Esigning workflows