BioPharma companies are making the switch from manual paper and hybrid file sharing solutions to high trust digital signing, automated workflows and standards-based content exchange in the cloud and on mobile devices in the rapidly growing cloud eTMF applications market.
Rancho Cordova,California, April 29, 2015
SureClinical’s value proposition of instant study startup, integrated high trust digital signing, integrated clinical operations workflows, integrated best in class eClinical applications and support for clinical study team collaboration across multiple global clinical studies and organizations, is compelling companies to switch from siloed cloud and on-premise applications to SureClinical.
Unprecedented Corporate and Customer Success
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 500% since April 2014. With these new customers, SureClinical now delivers its eTMF application and platform for digital signing 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.
SureClinical announced three new additions to its roster of Clinical Research Organization platform clients including ACT Oncology, MedSource and NovoTech. These organizations have agreed to license the SureClinical platform for multiple global clinical studies.
Additionally, SureClinical announced four new sponsor clients including Accelerate Diagnostics, DNAtrix, Ruthigen and Oculus Innovative Sciences.
Supporting Customer Quotes
“ACT Oncology manages complex oncology drug research trials for multiple sponsors globally,” said ACT Oncology Executive Director Rob Ott. “We needed a standards-based solution that had a flexible, easily modifiable content model, as well as digital signing and workflow tools to eliminate paper.” SureClinical’s flexible filing plan is based on the controlled vocabulary of the National Cancer Institute and the OASIS eTMF standard, enabling us to share content with sponsors and partners seamlessly.”
“We are excited to see the growth in adoption of SureClinical’s cloud applications and platform for clinical trial research and development,” said SureClinical CEO Zack Schmidt. “The rapid growth of CRO platform licensing indicates a movement toward standardization on SureClinical’s Certified Cloud applications for the R&D market.” “Our new CRO partners have committed to license the SureClinical Certified Cloud platform throughout their enterprise for multiple global clinical trials, indicating a growing movement toward standardization on SureClinical.
eClinical Cloud R&D Application Market to Top $5B Annually by 2018
SureClinical has been recognized as a leading eClinical eTMF application provider with integrated digital signing and workflow solutions for the eClinical application software vertical, a market which is expected to top $5B annually by 2018, according to a report by Markets and Markets.
Further, the market for BioPharma cloud software market segment 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™.
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, including clinical trial management systems (CTMS), electronic data capture system (EDC), and more, 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 digital signing, workflow and content management services on SureClinical’s Certified Cloud™. The combined value of SureClinical’s multi-study, multi-organization eTMF 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 eTMF data exchange standard for clinical trials. 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.
SureClinical’s eTMF application and platform for high trust digital signing helps life science organizations to accelerate the commercialization of therapies and technologies to market. 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 https://sureclinical.org.
Copyright © 2015 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.