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 and innovated therapeutic goods for local and international clients. Their team of highly experienced professionals supports a wide range of pharmaceutical and biotechnology companies progress the evolution of new products from pre-clinical stage through to marketing authorization.
Accelagen has partnered with one of the world’s largest vaccine manufacturer, Serum Institute of India Pvt Ltd to drive the early phase clinical development of their novel COVID-19 vaccine to assess the safety and immune response generated. The receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies.
In April of this year, SureClinical announced a complimentary COVID-19 eClinical application program to support medical research centers, CRO’s and Sponsors who are developing COVID-19 vaccines and treatments. With seven active global COVID-19 treatment studies underway on SureClinical’s Cloud and several more in the planning stages, SureClinical is pleased to support Accelagen’s important Phase 1/2 trial with access to its eClinical Cloud Suite to help seek the fastest path to an effective vaccine for COVID-19.
To minimize the time to commence this important study, Accelagen has partnered with SureClinical to utilise their clinical operations tools, including SureClinical eTMF. Through using SureClinical’s tools, SureClinical has assisted Accelagen with reducing the time and resources needed to activate the study and ensure all steps are completed efficiently. Their tools provides our Project team with an easy to use method to collect, record and track essential documents. “We are very grateful to SureClinical for their support of our critical work in this crucial trial. Using SureClinical, we are confident to be able to accelerate our study startup and improve trial management for our critical study to find effective treatments for COVID-19 patients”, says Greg Plunkett, Managing Director of Accelagen.
“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 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 many cases, reducing study startup times from 6-9 months to 3 months or less. When applied to COVID-19 clinical studies, these time savings can be significant in saving lives globally. We have extended 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 Experience at SureClinical.
Through this partnership with SureClinical, Accelagen will continue to build upon the success shown with these exciting studies to support the conduct of new studies on behalf of current and new clients.
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 digital signing.
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.
SureClinical is a premier provider of FDA and EU compliance validated eClinical cloud applications for life sciences and healthcare. Our mission is to provide integrated best-in-class applications to accelerate the delivery of innovative therapies to patients globally.
SureClinical provides life science and healthcare companies with a unified suite of applications, platform and network. SureClinical is available on all major web browsers as well as Android®, Apple® iPad, Apple® IOS, and other popular mobile platforms.
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About Accelagen Pty Ltd
Accelagen is a world-leading, full-service Contract Research Organisation (CRO), with a focus on clinical research and regulatory affairs. The exceptionally experienced team at Accelagen provides strategic guidance and support throughout all stages of product evolution, including the development, initiation and management of Phase I – IV clinical trials in Australia and New Zealand. Founded in 2010, Accelagen has developed many successful collaborations with local and international clients, maintaining a dedicated focus to successfully navigate the development pathways.
About Serum Institute
Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.6 billion doses) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe in their national immunization programs, saving millions of lives.
Serum is ranked as India’s No.1 biotechnology company, manufacturing highly specialized lifesaving biologics like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.
Serum was founded in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing life-saving immuno-biologics, which were in short supply in India and were being imported at extremely high prices. Thereafter, several life-saving biologics were manufactured by Serum with the result that the country became self-sufficient for Tetanus Anti-toxin and Anti-snake Venom serum, followed by the DTP (Diphtheria, Tetanus and Pertussis) group of Vaccines and then later with the MMR (Measles, Mumps and Rubella) group of vaccines.
The philanthropic philosophy of Serum continues with its work on newer vaccines such as Rotavirus vaccine , Meningitis A vaccine and other combination vaccines.