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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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SureClinical Launches Eclinical Ecosystem ECO Bundle to Support Clinical Trial Automation and Collaboration

Clinical operations ecosystem for Clinical Research Organizations streamlines and accelerates the delivery of new treatments to patients globally RENO, NV – December 16, 2021 – SureClinical, a leading provider of cloud-native eClinical applications, announced today the launch of their new Eclinical Ecosystem ECO Applications and Platform Bundle. Designed for the unique needs of Clinical Research …

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Announcing the New SureClinical ECO Bundle for Clinical Operations

The challenges facing clinical trial teams today    Life Science Clinical Operations teams struggle to connect, collect, access, view, report, analyze, and understand data from multiple applications and systems.   Recent market conditions, including the global pandemic, have caused businesses to look for ways to accelerate digital transformation by connecting the ecosystem of eClinical systems, …

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What’s the difference between electronic signatures and digital signatures?

Every day, individuals are more and more likely to sign documents electronically.  But, just what is an electronic signature? Are there different types of signatures? And, what type of signature is needed in different situations?  We will cover the above, and more, as we delve into the technology behind signing documents electronically. https://youtu.be/DkBykauPr5A Electronic signatures …

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Key “Critical to Quality” Factors in newly released ICH E8(R1) Guidance for Designing Quality into Your Clinical Trial

Clinical trials are incredibly important for bringing safe and effective treatments to market to help patients who need them.  With that in mind, the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use just released the final adopted ICH Harmonised Guidelines of General Considerations for Clinical Trials release E8(R1).  It is …

Key “Critical to Quality” Factors in newly released ICH E8(R1) Guidance for Designing Quality into Your Clinical Trial Read More »

Improving Clinical Trial ROI with Automation

Clinical trials continue to be burdened with paper and manual processes. Sometimes hybrid situations are used where there are some paper processes and some manual processes. Either system (all manual or hybrid) makes clinical trial documentation challenging as it is not all digitized.  However, the challenges are easily overcome by implementing digital documents with workflow …

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The Future of Clinical Trials: Going Digital With Remote Monitoring

The COVID-19 pandemic changed the way that we people live and work. Everything went online, from ordering groceries to remote collaboration with coworkers. The vaccines from Pfizer/BioNTech and Moderna have a lot of promise, making a world without COVID-19 seem on the horizon. But the reality is that it will be some time before we reach …

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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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