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 …
The Future of Clinical Trials: Going Digital With Remote Monitoring Read More »
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 …
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, …
Announcing the New SureClinical ECO Bundle for Clinical Operations Read More »
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 …
What’s the difference between electronic signatures and digital signatures? Read More »
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 …
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 …
By Guest Author: Dr. Karin Köhler-Hansner As a sponsor, do you contract out your clinical trials to a CRO and forget about them? Do you expect that once you sign the Transfer of Obligations form that you can relax and look forward to a perfectly packaged up final study report? You may want to rethink …
The Importance of Sponsor Oversight in Clinical Trials Read More »
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 …
SureClinical Supports Accelagen COVID-19 Phase 2 Trial Read More »
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 …
SureClinical Supports Asklepion Phase 2 Trial for COVID-19 Patients Read More »
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 …
SureESign Trusted Digital Signing for Health Sciences on Google Cloud Read More »
The COVID-19 pandemic has affected how we run clinical trials, and those Sponsors, CRO’s and Sites that are able to manage trial and patient data securely and digitally are the ones that have been most able to continue their trials with the least interruption. As the curve flattens in many parts of the world and …
Will Covid-19 be the Final Push for Digitizing Clinical Trial Management? Read More »
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 …
Complimentary eClinical Apps for COVID-19 Clinical Trials Read More »
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 …
If you are like many organizations who have implemented or considering a work-from-home policy for the immediate term or planning a broader long-term strategy with a distributed workforce, you are not alone. Most of us rely on productivity tools to get our jobs done, and Clinical Trials is no exception. We are doing our part …
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 …
Study Startup Case Study: Digital Signatures & Process Automation Read More »
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 …
Important Tips for a Successful CTMS and eTMF Implementation Read More »
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, …
This is the first in a series of blog posts sharing the expertise and voices of SureClinical employees, advisors and customers. This blog is focused on how a seasoned CRA chose the best eTMF and CTMS system. We welcome your feedback and your own experiences about your own digital journey. As a consultant CRA with more than …
A CRA’s Digital Journey, aka How I Learned to Love my eTMF Read More »
“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 …
Global Lunch and Learn Series for Clinical Operations Read More »
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 …
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. …
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 »
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 …
SureNetwork launches with Spring 2019 Suite for ClinOps Read More »
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 …
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 …
SureNetwork: First Trusted Clinician Network for Health Sciences Read More »
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 …
SureClinical Introduces Clinical Trial Cloud Archiving Solution 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 …
SureETMF Awarded Patent for Automating Paper-Based Processes 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 …
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 Newest Customers for eTMF and 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, …
Novotech Selects SureClinical eTMF to Automate Clinical Operations 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 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 …
SureClinical eTMF 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 …
Pharma and IT Collaboration on OASIS eTMF Standard for Clinical Trials Read More »
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