SureClinical SurePortal

The SureClinical SurePortal demonstration showcases a specialized software solution designed to eliminate the pervasive inefficiencies associated with manual, paper-based processes in clinical trials. The core purpose of the application is to transition clinical study teams, investigators, CROs, sponsors, and auditors to a 100% paperless environment, thereby addressing the traditional challenges of slow, costly, and labor-intensive document management—specifically printing, signing, scanning, and filing. The platform promises significant improvements in document quality, integrity, efficiency, and visibility across clinical trial workflows by automating critical steps, particularly the signing process, while ensuring strict regulatory adherence.

The central technological feature highlighted is the use of FDA-compliant Adobe PDF digital signatures, which automate the signing process for the entire clinical study team. The platform ensures document integrity and security through a patented High Trust Adobe Digital certificate signing feature. The demonstration illustrates a robust, multi-layered security protocol for e-signing, requiring the user (a Principal Investigator, Dr. John Sun) to confirm identity via a six-digit code sent to a mobile phone, followed by the entry of a personal PIN code and the selection of a reason for signing. This rigorous process ensures that the resulting document is digitally notarized and fully compliant with FDA 21 CFR Part 11 requirements, a critical standard for electronic records and signatures in the life sciences sector.

The workflow progression is demonstrated through a typical investigator task. Upon logging in, Dr. Sun receives an email and an in-app task notification requesting the upload and e-signing of his CV. The system streamlines the upload process by automatically tagging the document with the signer’s information. Once signed using the secure digital certificate process, the document is automatically placed in a "review status" for quality checks by study staff. Beyond signing, the portal functions as a comprehensive document management system, allowing users to quickly find documents using an expandable folder structure (document tree) or a powerful search feature (demonstrated by searching for a Serious Adverse Event or SAE report).

Furthermore, SurePortal facilitates collaboration and access control. Users can review documents within an integrated viewer, download them, or share them with colleagues using bookmarks, which can include associated messages for review requests (e.g., reviewing a prospective sub-investigator CV). The platform also offers customizable user preferences, allowing investigators to adjust document viewing settings, such as displaying category codes in the document tree, and manage their access rights to various studies. This focus on secure access, regulatory compliance, and streamlined workflow management positions SurePortal as a critical tool for modernizing clinical operations.

Key Takeaways: • Elimination of Paper-Based Inefficiencies: SurePortal directly tackles the slow, costly, and inefficient manual processes common in clinical trials by enabling 100% paperless document completion from the point of origin, significantly improving operational speed and reducing labor intensity. • Robust 21 CFR Part 11 Compliance: The platform achieves regulatory compliance through digital notarization and the use of FDA-compliant Adobe PDF digital signatures, ensuring that electronic records and signatures meet stringent industry standards. • Multi-Factor Digital Signature Security: The e-signing process incorporates multiple security layers, including a patented High Trust Adobe Digital certificate, confirmation via a six-digit code sent to the user’s mobile phone, and a personal PIN code entry, providing high assurance of signer identity and transaction integrity. • Automated Workflow and Task Management: Users receive immediate workflow task notifications via email and in-app dialogues, guiding them through required actions such as document upload and signing, thereby ensuring timely completion of critical study tasks. • Enhanced Document Integrity and Audit Trails: By eliminating paper, the system improves document quality and integrity. Once signed, the document is automatically placed in a review status, establishing a clear audit trail and workflow visibility for study staff. • Integrated Document Management System (DMS): The portal offers comprehensive document retrieval capabilities, including an expandable document tree organized by folders and a robust search feature allowing users to quickly locate specific documents (e.g., SAE reports) using keywords. • Secure Access and Collaboration Tools: The platform supports collaborative workflows through features like document sharing via bookmarks, which allows users to send specific documents along with review requests and comments to other study team members. • User-Centric Customization: Investigators can manage their access rights to specific studies and customize their viewing experience through settings menus, such as changing the appearance of the document tree by enabling category codes. • Universal Accessibility and Validation: Clinical study teams can access the platform anytime, anywhere across mobile and web-connected devices, and the use of standard Adobe Reader allows anyone to instantly validate the signatures and document integrity outside the SurePortal environment.

Tools/Resources Mentioned:

• SureClinical SurePortal
• Adobe PDF Digital Signatures
• Adobe Reader

Key Concepts:

• 21 CFR Part 11: The regulation established by the FDA governing electronic records and electronic signatures in the life sciences industry, ensuring their trustworthiness, reliability, and equivalence to paper records.
• Digital Notarization: The process by which the electronic signature is secured, timestamped, and verified, making the document legally binding and compliant with regulatory standards.
• High Trust Adobe Digital Certificate: A specific type of digital certificate used by SureClinical to ensure the security and validity of the electronic signatures, often involving stringent identity verification processes.
• Serious Adverse Event (SAE) Report: A critical document in clinical trials detailing unexpected and serious patient outcomes that must be reviewed and documented promptly.