SureClinical Awarded Patent for BioPharma Regulatory Content Management

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SureClinical eTMF becomes first patented app to help BioPharma and device companies to automate hybrid paper and electronic processes in clinical trials area

“SureClinical’s new patent addresses the need to automate both paper-based and electronic processes in a true hybrid cloud-based eClinical solution,” said SureClinical CEO Zack Schmidt.

SureClinical announced today that it was awarded a patent in the area of eClinical content automation for its electronic trial master file (eTMF) application solution, SureClinical eTMF. SureClincial’s new patent reinforces SureClincial’s leadership and innovation in the area of BioPharma clinical trial automation, further assisting BioPharma, medical device and clinical research organizations in their efforts to accelerate the delivery of new life saving therapies to patients in clinical trials globally.

SureClinical Automates Paper-Based Regulatory Processes for Customer Success

SureClinical automates manual paper-based BioPharma clinical operations and other ‘hybrid’ manual and electronic processes for BioPharma and medical device clinical trials. With SureClinical’s new patent “System and Method for Managing and Sharing Pharmaceutical Clinical Trial Regulatory Documents, US Patent 9,378,205,” SureClinical is the only eClinical cloud applications company that can offer multichannel content capture, classification and completion in eTMF applications that supports both paper-based content with barcodes and electronic content in a trusted cloud based platform.

SureClinical Patent Covers Automated Hybrid Content Collection

Clinical trial and healthcare applications often need to support a combination of paper-based and electronic processes. SureClinical’s patent covers ‘hybrid’ content collection and automation solutions – defined as solutions that need to support both paper and electronic content capture, classification, completion and sharing, all within a trusted, FDA compliance validated system.

“While SureClinical’s Network Applications Platform fully supports the industry trend to move away from paper in clinical trials and healthcare toward all electronic content and digital signatures, nonetheless paper and manual processes will continue for some time,” said SureClinical CEO Zack Schmidt. “SureClinical’s patent addresses the need to automate both paper-based and electronic processes in a true hybrid cloud-based eClinical solution.”

eClinical Cloud R&D Application Market to Top $5B Annually by 2018

SureClinical has been recognized as a leading eClinical application and platform provider. SureClinical is the only eClinical solutions provider to offer an eClinical cloud network application platform which includes a trusted clinician network, a platform for trusted digital signing, hybrid paper and electronic workflows, cloud storage and collaboration, as well as integration to best in class eClinical applications. The eClinical application software vertical is expected to top $5B annually by 2018, according to a report by Markets and Markets.

Further, the market for BioPharma cloud software has been deemed the single fastest growing vertical market segment in the entire enterprise software market. Growing demand for BioPharma SaaS solutions is expected to continue through 2018 as companies seek to eliminate manual paper-based processes and migrate to all electronic cloud solutions. As this migration continues, SureClinical and its customers will continue to benefit from the introduction of transformational technologies and solutions through the SureClinical Certified Cloud™.

Fueled by the movement of BioPharma organizations from manual paper-based processes to automated workflows in clinical trials, SureClinical has seen its customer base grow by over 1,000% since launching SureClinical in April 2014. SureClinical delivers its eTMF applications and platform to global BioPharma customers across a wide variety of therapeutic areas including oncology, medical devices, dermatology and more. SureClinical has received FDA and EC compliance validation for SureClinical eTMF and the SureClinical digital signing platform.

Commitment to Best In Class Technology and Partner Expansion

SureClinical’s customer growth has been driven in part by the company’s focus to partner with best in class eClinical application vendors across multiple eClinical application areas, providing a compelling single portal experience for clinical trial planning, management, development, tracking and collaboration. With SureClinical Connect™, the company’s standards-based integration engine, companies can accelerate connectivity to the SureClinical platform through a centralized API, facilitating standards-based application and user authentication, with integrated access to dashboard analytics, digital signing, workflow, and content management services on SureClinical’s Certified Cloud™. The combined value of SureClinical’s multi-study, multi-organization applications and platform along with best in class eClinical application integration creates significant productivity and quality process enhancements for SureClinical’s global clinical trial customers.

Industry Thought Leadership in Clinical Trial Data Exchange Standards

In an effort to help promote global clinical trial efficiencies that can accelerate the delivery of new therapies and technologies to patients, the company continues to make substantial contributions to the development of a global data exchange standards. SureClinical is the founder of the OASIS eTMF Standard Technical Committee, a global initiative to develop an ISO standard vendor-neutral format for clinical trial data exchange of electronic trial master file data between sponsors, CRO’s, regulators and auditors. SureClinical, application vendors and other BioPharma industry leaders have been collaborating with CareLex, HL7, the National Cancer Institute, OASIS and the TMF Reference Model group to develop a controlled eTMF vocabulary and machine readable data exchange format which is expected to facilitate sharing of clinical trial data between organizations. Recently over 800 BioPharma industry community contributions were made to the OASIS eTMF standardization effort, representing the joint efforts of hundreds of sponsors, clinical research organizations, standards groups and individuals worldwide.

About SureClinical

SureClinical’s applications and platform helps life science and healthcare organizations to improve patient care globally through the accelerated delivery of new therapies and innovative services. SureClinical is the only company to offer validated FDA and EC compliant applications with integrated high trust digital signing and workflows to eliminate paper in clinical trials. SureClinical’s network cloud application solutions enable clinical study teams to collaborate across multiple global clinical studies and multiple organizations from a single web portal. For more information, visit View this release and related SureClinical News at:

Copyright © 2016 SureClinical. All rights reserved. SureClinical, SureEsign, SureTrial, Certified Cloud, SurePortal and the SureTrial logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.

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