There’s an important new global standards initiative that quietly launched on December 16th  in the BioPharma regulatory area called the OASIS eTMF Standard.   For clinical trial practitioners, the OASIS eTMF Standard represents a new high-water mark for delivering on the vision of 100% paperless clinical trials and clinical trial process automation across organization boundaries.   For the majority …

The Start of a New Era for Clinical Trials Read More »

SureNetwork is the first trusted clinical trial network application for life sciences – enabling shorter clinical trial cycle times and better outcomes through accelerated study team search, qualification, recruitment and activation. RENO, Nev. (PRWEB) June 21, 2019 Built for clinical operations professionals by clinical operations professionals, SureClinical today announced the launch and availability of its Spring …

SureClinical Launches SureNetwork with Spring 2019 Suite for Clinical Operations Read More »

On Monday Jan 6 the OASIS eTMF Standard Technical Committee approved a three-tier technical architecture for the representation and exchange of electronic trial master file data. The technical architecture includes a Content Classification Layer, a Vocabulary Layer, and a Web Standard Technology Layer. Further, the team approved the use of RDF/XML to describe, share and …

OASIS eTMF Standard TC selects architecture and format for eTMF data Read More »

With the proliferation of software solutions containing sensitive data, many individuals, technologists, and corporations are rightfully concerned about the pervasive threat of large-scale penetration of private and public clouds. The hacking of big-box retailer Target in early December 2013 is a prime example of how malicious hackers can penetrate a network and abscond with private data. …

Not all Clouds Have a Silver Lining Read More »

Some of you might be asking, “Why do I need a collaboration tool that streamlines the regulatory document completion process? Is it really that important?”  On Dec. 31st, there was a short article published in BioSpace that shines a spotlight on the very reason why eliminating paper-based regulatory documents in clinical trials makes sense. According to the …

China Suspends Imports of HIV-Drug on Regulatory Doc Glitch Read More »

SureClinical announced today that it was awarded a patent in the area of eClinical cloud application automation for its electronic trial master file (eTMF) application solution, SureClinical eTMF.  SureClincial’s new patent reinforces SureClincial’s leadership and innovation in the area of BioPharma clinical trial automation, accelerating the delivery of new life saving therapies to patients in clinical …

SureClinical eTMF earns patent for solution that helps BioPharma companies automate hybrid paper and electronic processes in the eClinical applications market Read More »

On June 25th, the global clinical trials industry took a giant step toward global clinical trial data standardization with OASIS Open’s publication of the OASIS eTMF Committee Specification Draft V1.0 for clinical trial regulated content management interoperability.  SureClinical is the first eTMF vendor to announce native support for RDF/XML, the core technology specified in the …

OASIS eTMF Standard Draft Approved Read More »

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 …

SureClinical Announces Six New Customers in Q1 2015 for eTMF Application and Platform for High Trust Digital Signing Read More »

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, …

SureClinical eTMF Cloud Selected by Novotech to Automate and Accelerate Clinical Operations Processes Read More »

An independent compliance audit found that SureClinical eTMF Cloud meets or exceeds European Commission and FDA regulatory requirements. Rancho Cordova, CA  December 01, 2014  – SureClinical, a global provider of cloud-based content management application software and services for health sciences, announced today that it has successfully completed an independent FDA 21 CFR Part 11 and …

SureClinical Wins FDA Part 11 and EC Annex 11 Compliance Validation Read More »

SureClinical is first eClinical application provider to offer integrated digital signing in the cloud from mobile and web with high trust Adobe Digital IDs and integrated workflows, automating manual, paper-based processes to help organizations transform into fully digital paperless businesses. Rancho Cordova, California (PRWEB) June 19, 2014 SureClinical Inc., an industry-leader in collaborative cloud health …

SureClinical eTMF Spring 2014 Release Enables 100% Paperless Clinical Trial Operations Read More »

Forte Research, HL7, Kaiser Permanente, Mayo Clinic, Oracle, SureClinical, and Others Advance Interoperability Standard for Exchanging Clinical Trial Content in the Cloud BOSTON–(BUSINESS WIRE)– The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical …

Pharmaceutical and IT Communities Collaborate on OASIS eTMF Standard for Clinical Trials Read More »

SureClinical hires new Global VP of Sales from Dell Software Division to fuel worldwide growth. Rancho Cordova, CA  February 18, 2014 SureClinical, a leader in cloud-based health science applications, today announced that Louis (Lou) E. Chappuie will join SureClinical’s executive team as Global Vice President of Sales.

SureClinical® eTMF’s rapid cloud deployment, ease-of-use, and unique medical imaging support for clinical trials is 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.

Nearly fifteen years after its introduction, SharePoint is showing its age. User surveys and reports suggest that SharePoint 2013 is not cloud ready, is hard to use and lacks out of the box FDA 21 CFR Part 11 compliance validation when used in clinical trials. Rancho Cordova, CA   January 27, 2014 SureClinical announced today the …

SureClinical Releases Evaluating SharePoint-Based eTMF Applications White Paper Read More »

Forward-thinking Biopharma and healthcare companies are increasingly looking to cloud-based computing solutions for digital document signing and completion. This approach helps in replacing labor-intensive paper document scanning and reducing document completion costs significantly, says SureClinical, a provider of collaborative cloud application solutions for Health Science.

SureClinical Announces SureClinical Certified Cloud for North America and Europe First Health Science Application Cloud Platform with Integrated Electronic Signing to offer certifications for US FDA 21 CFR Part 11 and European Commission regulations. Rancho Cordova, California  November 27, 2013

SureClinical Announces SurePortal, First 100% Paperless eTMF Investigator Portal for Automated Document Completion Across Mobile, Web New clinical trial eTMF Solution eliminates paper at the point of origination for productivity and cost savings with an immediate return on investment Rancho Cordova, California  October 31, 2013

SureClinical partners with DigiCert to deliver new high-trust E-signing platform, provide FDA-Compliant Digital Certificate Signing services using web and mobile devices RANCHO CORDOVA, Calif.  October 23 2013– SureClinical™, a leading provider of secure pharmaceutical and healthcare clinical content management solutions, announced today an exclusive partnership with DigiCert®, a global leader in authentication and encryption services, …

SureClinical First to Provide Secure Mobile Esignature Capability in the Cloud Read More »

SureClinical eTMF is the First eTMF Cloud Software Solution To Completely Address FDA 21 CFR Part 11 Regulations Rancho Cordova, CA (PRWEB) August 01, 2013  -SureClinical, a provider of cloud-based content management application software and services for health sciences, announced today that it has successfully completed an FDA 21 CFR Part 11 compliance audit of its SureTrial® …

SureClinical eTMF Cloud FDA 21 CFR Part 11 Compliance Audit Successfully Completed Read More »

SureClinical eTMF Cloud Edition V2.1 supports multi-organization digital signing on mobile and desktops Rancho Cordova, CA   June 27, 2013SureClinical, 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 …

SureClinical eTMF Cloud Edition V2.1 Launched Read More »