New FDA Part 11 Compliance Validated Offering Provides Cost Effective Alternative for BioPharma Enterprises who want Simple, Scalable Cloud Storage for Completed Clinical Trial Documents and Medical Images
RANCHO CORDOVA, CALIF. (PRWEB) NOVEMBER 02, 2017
SureClinical, the Health Science Cloud Applications company, today announced its new SureArchive offering, a cost-effective, scalable global repository for BioPharma organizations to archive completed clinical studies in the cloud. Designed to scale and support organizations with hundreds of clinical trials, SureArchive supports in-country archiving through its Certified Cloud™, a network of global Tier 3 FDA Part 11 and HIPAA compliance validated data centers, hosted by Dimension Data, a member of the NTT Group. NTT Group is a global technology company with total revenues of $105 billion and over 230 data centers in 88 countries worldwide.
In addition to its Certified Cloud offering, SureArchive delivers a simple to use mobile-ready web browser solution that provides internal or external clinical stakeholders, auditors or inspectors with secure, controlled access to clinical trial documents and medical images. SureArchive supports document classification using the OASIS eTMF Standard, the TMF Reference Model or organization specific custom classification and metadata tagging schemas. With SureArchive, clinical study documents are intuitively organized, easily retrieved, and audit ready. For organizations looking for a cost effective clinical study archiving solution, SureArchive offers the ability to import completed clinical study data from existing electronic trial master file (eTMF) systems, medical images, cloud based applications or even scanned documents into SureArchive.
For large BioPharma organizations with skyrocketing clinical trial eTMF software license subscription costs that can run into the millions of dollars annually, a feature-rich, low-cost FDA Part 11 validated clinical trial cloud archiving solution makes financial sense for long-term preservation of clinical trial digital assets. SureArchive starts as low as $600/month per study, with unlimited sites, making it an attractive alternative to storing clinical studies in enterprise eTMF cloud systems that can cost as much as 10 times more per month to archive a single clinical study. While clinical operations and financial managers seek to preserve, protect and manage valuable clinical trial content, finding a cost-effective FDA compliant, validated clinical trial cloud solution can be a major challenge.
Anytime, anywhere access to completed clinical studies for on-demand audit readiness is simple via SureArchive’s mobile web client. The zero-install secure mobile web client provides global secure access from popular web browsers on laptops, Apple® or Android® mobile devices to clinical trial content over SureClinical’s Certified Cloud network infrastructure. SureArchive contains built in required document reporting, missing document reporting, medical image and document viewing, audit trail viewing and many more content management features found only in SureClinical’ industry leading cloud eTMF application, SureETMF.
“With SureArchive I can access my TMF study documents for completed studies from my Apple iPhone®. I can retrieve, view and share TMF documents in seconds virtually anywhere, anytime,” said Cornelia Baumgartner; Associate Director Clinical Operations, Aridis Pharmaceuticals Inc.
Regulatory Professionals Inc., a San Francisco Bay Area firm that offers strategic and tactical regulatory services in accordance with FDA/ICH standards in all phases of drug development, works with sponsors, CROs and clinical research teams on a wide range of regulatory document management services, including eTMF cloud archiving and management. “Regulatory Professionals, Inc. (RPI) is excited by the collaboration with SureClinical that provides RPI the ability to offer eTMF management services, allowing Sponsors to maintain real time access, control and oversight of Sponsor’s eTMF,” said Donna Kato, President and CEO.
“As BioPharma and healthcare organizations continue to automate and digitize paper-based processes through cloud-based eTMF and content management systems, they need a cost-effective solution to archive completed clinical studies. SureArchive and SureClinical’s Certified Cloud™ is a simple to use, trusted solution that will lower clinical trial archiving costs by orders of magnitude over existing eTMF archiving solutions,” said Zack Schmidt, President and CEO of SureClinical.
For more information on SureClinical’s new SureArchive cloud service for clinical trials, please visit: http://sureclinical.com/etmf/surearchive/
For more information on Regulatory Professionals Inc., please visit: http://www.regprofessional.com/
About SureClinical SureClinical is a leading provider of cloud based health science applications. SureClinical’s applications, platform and network automate and digitize manual processes, helping life science organizations to accelerate the commercialization of therapies and technologies to market. SureClinical is the only company to offer validated FDA and EC compliance validated cloud 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 http://www.SureClinical.com.
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