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.
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 global COVID-19 treatment studies underway on SureClinical’s Cloud, SureClinical is extending its complimentary offer of its eClinical Cloud Suite to help research entities seek the fastest path to global eradication of COVID-19.
“SureClinical is launching this program as our way of contributing to the global effort in a way we know we can have a huge impact: accelerating study timelines with fully digital platforms and transactions,” said Zack Schmidt, CEO of SureClinical.
Never before has speed been so important in seeking global therapies and treatments for COVID-19. With a proven track record of reducing study startup time by over 70% from manual, paper or spreadsheet based systems, SureClinical’s eClinical Applications and Enterprise Collaboration Platform helps studies streamline their essential document collection and study startup processes as well as support remote clinical monitoring. SureClinical’s application suite includes FDA 21 CFR Part 11 and EU Annex 11, HIPAA compliance validated solutions for Clinical Trial Management (CTMS), Electronic Trial Master File (eTMF) management, Electronic Investigator Site File (eISF) management, Quality Management (QMS), SureNetwork and SureEsign.
FDA guidance has been updated and is rapidly evolving to support accelerated trial processes, including virtual trials, remote monitoring, and digital technology. SureClinical is in a great position to support that guidance. “We do our best to look at where Clinical Trials will be in a few years, and develop software to support where the market is going. “Virtual” has been a buzzword for several years now, but until the COVID-19 pandemic, has been more theoretical than actual. We designed and developed our unified software suite to support these trends, and have been able to assist our customers in pivoting quickly,” states Schmidt. One customer, Clinilabs Drug Development Corporation, has been able to move a 100+ site study from in-person to remote monitoring with virtually no downtime other than to update work instructions.
“We at SureClinical are proud that our eClinical applications and platform are being used to speed the development and delivery of multiple global COVID-19 treatment and vaccine clinical trials. Our platform provides a digital transformation path for our vaccine development customers, providing better clinical trial operational intelligence – including historic, current and predictive analysis. Customer supporting data shows that our solutions have accelerated clinical study startup by over 50%, in some cases, reducing study startup times from 6 months to 3 months or less. When applied to COVID-19 clinical studies, these time savings can be significant in saving lives globally. We’d like to extend our help to others as we all work together to rapidly find, validate and release treatments to combat this pandemic,” states Laurie Pattison, VP of Marketing and Customer Success at SureClinical.
SureClinical has been supporting clinical research organizations, medical research centers and BioPharma sponsors since 2014 to streamline clinical trial processes. “Our overall goal has never waivered: to speed the development and delivery of life-saving drugs and therapies to patients through our applications,”states Zack Schmidt, CEO of Sure Clinical. “The market has been good to us. This is the way we can give back when it matters most.”
If you are embarking on a new COVID-19 study and would like to leverage the SureClinical platform, please contact SureClinical to see if you are a candidate for a free trial.