SureClinical eTMF Helps Derm Products Companies Win FDA Approval – SterlingBio Smart CRO Services and Solutions

SureClinical eTMF Helps Derm Products Companies Win FDA Approval

SureClinical® eTMF’s rapid cloud deployment, ease-of-use, and unique medical imaging support for clinical trials are helping leading dermatology products companies win FDA clearance. The successful deployment and FDA approval by users of SureClinical eTMF cloud is further proof that BioPharma companies are increasingly automating manual paper-based clinical trial approaches with SureClinical’s SureClinical eTMF cloud application.

Rancho Cordova, CA January 31, 2014 SureClinical, Inc., an industry leader in cloud health sciences applications, announced today the successful deployment and use of its SureClinical eTMF Cloud application for two BioPharma customers in the Dermatology products area. Within nine months of initiating its double-blind, multi-center, randomized clinical scar study, SureClinical eTMF Cloud customer, Oculus Innovative Science, recently received FDA 510(k) clearance for its Microcyn™ Scar Management HydroGel study. Oculus utilized the SureClinical® eTMF Cloud platform to manage, share, and archive its clinical regulatory documents and medical images for its Scar Management study. SureClinical’s innovative solution enabled Oculus to acquire, auto-classify, and manage clinical trial eTMF regulatory content and medical images from desktop, mobile and web devices via SureClinical’s HIPAA and FDA 21 Part 11 Certified Cloud™. “Prior to using the SureClinical eTMF Cloud, all of our clinical trial regulatory documents were painfully captured on paper which required printing, scanning, and filing,” explained Brian Martin, Director of Regulatory. “Our ability to digitally share medical images and regulatory documents in the Cloud proved instrumental in receiving our 510(k) clearance without spending $100,000’s of dollars on paper processes or costly on-premise software.” In addition to Oculus, Clinical Research Organization SterlingBio has deployed SureClinical eTMF for its clients in the Dermatology area. SterlingBio’s regulatory documents associates can simply drag and drop electronic content from Microsoft Outlook® email client, desktop folders, and even medical imaging sources directly into the SureClinical eTMF cloud repository, automating content classification and making documents and medical images available through mobile and web devices. SureClinical eTMF is an industry-first FDA Part 11 Cloud service purpose-built for clinical trial practitioners to manage the entire lifecycle of regulatory documents from origination to document signing entirely in the Cloud. SureClinical delivers an intuitive user experience that enables drag-and-drop classification of email and documents directly to the content model tree. It provides flexible import of the OASIS eTMF content model at the initiation of each study complying with emerging industry standards and best practices. “Oculus and SterlingBio understand that managing and deploying TMF software, hardware and infrastructure is not an effective use of their resources. Instead of deploying on-premises or custom solutions, they realized that SureClinical’s Certified Cloud computing platform provides them with the safest route to FDA approval and is the best approach to delivering critical therapies to market,” said Zack Schmidt, CEO of SureClinical. “BioPharma companies are increasingly looking for a fast ramp-up to cloud computing to streamline clinical operations. Gone are the days of sending study documents overnight, waiting patiently for completed documents, only to waste time and energy scanning originals. Besides causing endless frustration, paper processes are just not economical or environmentally sensitive in 2014.” SureClinical eTMF further incorporates patent-pending high-trust digital signing directly in its framework, eliminating the need for life sciences companies to procure and integrate costly signing technologies. CRO’s, sponsors, and investigators can readily and securely sign documents from any connected mobile device, anywhere in the world without opening ports in firewalls or requiring a federation of security. Moreover, since it is cloud-based, SureClinical customers can activate studies within minutes delivering scale-up and scale-down flexibility based on need, without having to invest in underused on premise infrastructure or software. In a nutshell, SureClinical eTMF Cloud automates and streamlines clinical processes, eliminating paper, which is good for the customer’s bottom-line as well as the environment. Additional Information About SureClinical SureClinical provides cloud-based health science applications that automate business processes and eliminate paper. SureClinical’s Certified Cloud includes integrated document completion, Esigning and archiving for networks of health science organizations that wish to share documents in an automated, regulated cloud environment. SureClinical’s applications run on Android®, Apple® iPad, Apple® IOS, and other popular smartphone platforms, as well as on all major web browsers. For more information, visit About Oculus Innovative Science Oculus Innovative Science is a global healthcare company that designs, manufactures, and markets prescription and non-prescription products in 27 countries. The company’s products, with over 100 SKUs commercialized worldwide, are used to treat patients in surgical/advanced wound management, dermatology, women’s health, and animal health; addressing the unmet medical needs of these markets—while raising the standard of patient care and lowering overall healthcare costs. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. For more information, visit About SterlingBio SterlingBio provides pharmaceutical and biotech development services to leading pharmaceutical, biotechnology, and medical device companies. SterlingBio delivers sterling results for biotech and pharmaceutical clinical trials through our superior team, close customer interaction, our technology and the application of industry best-practices learned over years of successful clinical trials across a wide range of therapeutic areas. For more information go to Copyright © 2014 SureClinical. All rights reserved. SureClinical, SureEsign, SureClinical, Certified Cloud, SurePortal, and the SureClinical logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.