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High Trust Signing – How to Ensure your eSigned documents are Compliant

Trust is the cornerstone of all health and life science interactions, whether it’s following Good Clinical Practice in running clinical trials or in a patient-doctor relationship.  The need for high trust carries throughout everything, including how documents and people are validated.  I sat down with our CEO, Zack Schmidt, who shared his insights into why …

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Important Tips for a Successful CTMS and eTMF Implementation

Implementation of an advanced CTMS, eTMF and eClinical platform can bring huge benefits to a business. The FDA has adopted digital submission requirements and the Sponsors and CRO’s we work with have all seen the benefits of “going digital”, or they wouldn’t have contracted with SureClinical for their CTMS, eTMF or eClinical Platform. They are …

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Audit Readiness: High. Stress: Low

Whether you’re a CRO being constantly audited by your Sponsor, or part of a pharmaceutical company preparing for your first FDA Pre-Approval Inspection (PAI), in our industry we must always be audit and inspection ready.  As the compliance manager of a software company that caters to the highly regulated pharma, biotech, and medical device industries, …

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SureClinical Supports Accelagen COVID-19 Phase 2 Trial

Seeking the Fastest Path to a COVID-19 Vaccine SureClinical, the premier provider of FDA and EU compliance validated eClinical cloud applications today announced its complimentary support for Accelagen Pty Ltd Phase 1/2 COVID-19 trial on the SureClinical Platform. Accelagen is an Australian-based full service clinical research and regulatory affairs CRO supporting the development of new …

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SureClinical Supports Asklepion Phase 2 Trial for COVID-19 Patients

Working Together to Improve Patient Outcomes SureClinical, the premier provider of FDA and EU compliance validated eClinical cloud applications today announced its complimentary support for Asklepion Pharmaceuticals Phase 2 COVID-19 trial on the SureClinical Platform. The goal of Asklepion’s study is to prevent or reduce the severity of Covid 19 (SARS-CoV-2) associated ARDS (Acute, Respiratory …

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SureESign Trusted Digital Signing for Health Sciences on Google Cloud

FDA Part 11 Validated Cloud Signing for SureClinical’s eClinical Applications Now Available on Google Cloud SureClinical, a premier provider of eClinical cloud applications, today announced the release and immediate availability of SureESign®, its trusted digital signing solution for Health Sciences, on Google Cloud. SureESign® provides a private trusted signing network using Google Cloud HSM cluster …

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Complimentary eClinical Apps for COVID-19 Clinical Trials

Seeking the Fastest Path to Global Eradication of COVID-19 Virus   Reno, Nevada, April 15 2020 – SureClinical, the premier provider of FDA and EU compliance validated eClinical cloud applications today announced a complimentary COVID-19 eClinical application program to support Clinical Research Organizations and Sponsors who are developing COVID-19 vaccines and treatments.  With four active …

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SureClinical COVID-19 Response

The global, unprecedented COVID-19 pandemic is affecting all our families, businesses, communities, and way of life. Here is how we’re approaching the situation at SureClinical: SureClinical maintains and exercises a business continuity plan to ensure that during a significant event, our employees remain safe, that the SureClinical platform remains fully operational for our customers and partners, and that all customer …

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Study Startup Case Study: Digital Signatures & Process Automation

TORONTO (PRWEB) FEBRUARY 13, 2020 Clinical trial study startup processes are an area ripe for optimization. Often, the study time clock doesn’t start ticking until First Patient In (FPI), but research shows that the process to get to FPI can take seven months or longer on average. This webinar will explore best practices for study startup …

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Global Lunch and Learn Series for Clinical Operations

“Turbocharge Your Clinical Trials” Series Demonstrates Real-World Benefits of Going Digital NEW YORK, NY (PRWEB) OCTOBER 17, 2019 — SureClinical, a global provider of innovative cloud solutions for the health sciences market and Clinilabs Drug Development Corporation, a CNS-focused contract research organization, are sponsoring a global Lunch & Learn series demonstrating how sponsors can streamline and accelerate …

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The Start of a New Era for Clinical Trials

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 …

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OASIS eTMF Standard TC selects architecture and format for eTMF data

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 …

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Not all Clouds Have a Silver Lining

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. …

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China Suspends Imports of HIV-Drug on Regulatory Doc Glitch

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 …

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SureNetwork launches with Spring 2019 Suite for ClinOps

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 …

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SureClinical Announces SureCTMS

SureClinical Announces SureCTMS, First Mobile eClinical Trial Management System SureCTMS™ delivers the first clinical trial management system with an easy-to-use, mobile-first design for web, Apple and Android devices. Includes integrated document management, Adobe Digital Certificate signing, automated workflows, dashboard analytics, and SureNetwork access. RENO, Nev. (PRWEB) September 05, 2018 SureClinical announced today the release and FDA …

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SureNetwork: First Trusted Clinician Network for Health Sciences

Like a LinkedIn™ for the health sciences market, SureNetwork will lower clinician recruitment and staffing costs through a collaborative network of trusted health science organizations and professionals SAN MATEO, CALIFORNIA (PRWEB) MARCH 15, 2018 As part of its growing suite of eClinical applications and platform for Health Sciences, SureClinical today announced and previewed SureNetwork, a trusted …

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SureClinical Introduces Clinical Trial Cloud Archiving Solution

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 …

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SureETMF Awarded Patent for Automating Paper-Based Processes

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 …

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OASIS eTMF Standard Draft Approved

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 …

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SureClinical Newest Customers for eTMF and High Trust Digital Signing

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 …

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Novotech Selects SureClinical eTMF to Automate Clinical Operations

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, …

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SureClinical Wins Part 11 Compliance Validation

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 …

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SureClinical eTMF Enables 100% Paperless Clinical Trial Operations

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 …

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Pharma and IT Collaboration on OASIS eTMF Standard for Clinical Trials

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 …

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SureClinical Enhances Customer Experience with New VP Sales

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 Helps Derm Products Companies Win FDA Approval

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

In Health Science IT, Scan is the New Four-letter Word

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.

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