Internationally recognized clinical research firm Novotech announces selection of SureClincal eTMF Cloud for multiple clinical trials to help automate and manage the regulated clinical trial process, enabling accelerated clinical operations and enhanced quality for Novotech’s global clinical studies.
Rancho Cordova, CA, December 22 2014 — SureClinical Inc., an industry-leader in collaborative cloud health sciences applications, announced today the selection of SureClinical eTMF by Novotech, an internationally recognized full-service clinical research organization (CRO) firm headquartered in Sydney, Australia. Novotech works predominantly with U.S. and EU pharmaceutical and biotech companies and is currently managing around 100 trials across a wide range of therapeutic areas including oncology and cardiovascular disease.
The SureClinical cloud eTMF will initially be deployed to key, selected trials at Novotech to facilitate streamlined clinical trial operations such as study startup, regulatory document management and reporting, and regulatory document tracking in the electronic trial master file area for multi-year clinical trials.
“Before the adoption of SureClinical eTMF, Novotech’s clinical trial regulatory documents were captured on hybrid systems which required manual processes such as printing, scanning, tracking and filing,” explained Lynda Shelley, Executive Director of Clinical Operations at Novotech. “Now with SureClinical eTMF Cloud, internal and external clinical study stakeholders can collaboratively complete, digitally sign and share regulatory and study information in the cloud from mobile or web. This strategic capability allows us to eliminate paper at point of origin, accelerating document completion and enhancing document quality.”
In its search for the ideal eTMF to support automation of clinical trial document capture globally Novotech evaluated multiple solutions, including on-premise software and cloud solutions. “SureClinical was selected for its global FDA and EU compliant Certified Cloud™ operations and support, automated document acquisition and workflows, integrated digital signing, configurable filing plan, user-friendly interface and support for the new OASIS eTMF Standard for machine readable clinical trial content exchange,” said Lynda Shelley. “We look forward to cultivating a fruitful partnership with SureClinical in the eTMF applications area across multiple clinical trials.”
“We are thrilled to partner with Novotech to provide them with access to our global Certified Cloud service, helping them to automate and streamline clinical study operations from pre-study planning to submission and product approval,” said Zack Schmidt, President and CEO of SureClinical. “It is a sincere pleasure to work with the entire Novotech team, their sponsors and stakeholders in their quest to deliver 100% paperless clinical trials.”
SureClinical eTMF Cloud – Shred the Paper Mountain (TM)
SureClinical’s cloud software is used globally by life sciences organizations to accelerate clinical trials through the electronic capture, completion and digital signing of documents. SureClinical designs, develops, and delivers health sciences cloud software globally through 12 global data centers that are HIPAA and FDA 21 CFR Part 11 compliant. SureClinical’s SureWorkflow and patent-pending high trust digital signing is part of an integrated solution, enabling clinical trial sponsors, CRO’s, investigators and stakeholders to collaborate, complete and Esign documents through automated workflows, eliminating paper at its origin. 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 federation of security. Moreover, since it is Cloud, 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. SureClinical eTMF Cloud automates and streamlines clinical processes, eliminating paper, which is good for the customer, environment, industry, and the customer’s bottom-line.
Headquartered in Sydney, Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional full-service CRO. With the increasing pace of globalization in drug development, Novotech’s expertise in the vibrant and fast growing Asian region was instrumental in the success of hundreds of phase I-IV clinical trials. With operations in Australia, New Zealand, South Africa, Hong Kong, China, India, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand, Novotech’s service offering is recognized for its quality its clients and industry analyst groups. Get more info information at novotech-cro.com
SureClinical provides cloud-based health science applications that automate business processes and eliminate paper. SureClinical’s Collaborative 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, contact SureClinical.
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