Rancho Cordova, CA (PRWEB) June 27, 2013
SureClinical, a provider of cloud-based content management application software for health sciences, announced today that it has delivered the first cloud-based electronic trial master file (eTMF) solution for clinical trials with integrated multi-organization digital signature support on mobile and desktop devices. SureClinical eTMF is the first cloud eTMF solution to offer FDA 21 CFR Part 11 compliant digital signing across multiple organizations on mobile devices globally.
As clinical trial research organizations move from paper-based research to networked cloud computing solutions, digital document signing processes and automated workflows are a key factor in accelerating the safe delivery of therapies to patients. SureClinical eTMF Cloud V2.1 meets FDA 21 CFR Part 11 and European Medicines Agency requirements for digital signatures in regulated clinical trial content management. For more information on how SureClinical eTMF meets FDA 21 CFR Part 11 compliance, please download the SureClinical eTMF Cloud Compliance White Paper.
"In an increasingly networked environment for research, clinical trial content must be securely shared and managed across multiple organizations, including life sciences companies, contract research organizations (CROs), academic medical centers, outsourcing vendors and regulators,” said Zack Schmidt, CEO of SureClinical. “SureClinical eTMF breaks down the boundaries between clinical research organizations with integrated digital signing from desktop or mobile devices, accelerating document workflows and enhancing user productivity for global clinical trials."
SureClinical eTMF Cloud Edition provides a number of customer benefits over legacy content management systems. Instead of sending documents via overnight mail for signature, documents can be signed from supported mobile smart phone devices, saving overnight fees, enhancing document quality and providing immediate visibility into the status of clinical trial documents.
SureClinical eTMF Cloud Edition provides the industry's broadest clinical trial content management feature set with agency compliance, including features such as:
-Integrated Digital Signing: Lower document completion costs and ensure document quality and integrity with integrated FDA compliant digital signing with SureEsign™ with automated signer and signature validation.
-Multi-Organization Digital Signing from Mobile Devices: Instead of limiting digital signing to users within a single organization, SureClinical eTMF cloud edition lets multiple organizations digitally sign study documents from mobile and desktop devices.
-Automated Document Acquisition: Streamline operations by eliminating manual document processing. Collect and digitally sign documents globally using automated workflows with central management with SureWorkflow™.
-eTMF Document Quality Module: Enhance study document and medical image quality and compliance with SureQuality™. Now global clinical research teams can discover, report, remedy and measure clinical trial document discrepancies through a centrally visible and managed eTMF quality application.
-Open platform and architecture using Oracle® Java® and health industry standards-based metadata from CareLex.org, the eTMF content classification standards organization
The SureClinical eTMF Cloud Edition V2.1 is available now direct from SureClinical in pricing based on a per-study, per-site basis. For additional licensing and pricing information, visit http://www.SureClinical.com.
SureClinical is a provider of cloud-based content management application software for health sciences.
Headquartered in the Northern California, SureClinical's founders have proven expertise in delivering market leading enterprise applications in the health sciences and enterprise mobile computing areas.
To find out more, visit http://www.SureClinical.com.
SureClinical, SureClinical eTMF are trademarks of SureClinical.
Oracle® and Java® are registered trademarks of Oracle and/or its affiliates.
Copyright © 2013 SureClinical. All rights reserved. SureClinical, SureClinical eTMF and the SureClinical S logo and SureClinical Cloud logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.