Uckun and I have previously worked with the APCER team and we have been impressed by their dedication as well as the quality of their services. Fatih Uckun, MD, PhD, the Chief Medical Officer and Chief Scientific Officer of Reven, explained: “According to a fit-for-purpose safety management plan, APCER will (i) set up a global integrated PVG safety database, (ii) provide clinically trained safety specialists and physicians to triage serious and non-serious adverse event (AE) cases, (iii) perform detailed case entry and follow-up, quality reviews and medical reviews, (iv) manage the serious adverse event (SAE) reporting, as well as (v) coordinate safety monitoring processes to immediately identify suspected unexpected serious adverse reactions (SUSARS) and enable their on-time reporting to regulators, investigators and institutional review boards (IRBs).” “I also look forward to working with the APCER team as we perform signal evaluation and management for RJX and develop our risk evaluation and mitigation strategies,” Dr. Reven today announced that it selected the global specialty drug safety services provider APCER Life Sciences (APCER) as its preferred vendor to provide pharmacovigilance (PVG), safety monitoring, quality assurance and regulatory affairs services for its COVID-19 clinical project.
REVEN PROGRAM FOR DESIGNING HOUSES TRIAL
The upcoming clinical trial is designed to evaluate the safety and efficacy of RJX in COVID-19 patients.
Reven is planning to initiate a randomized, double-blind, placebo-controlled, multi-institutional clinical trial of its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) in the treatment of COVID-19. (“Reven”) is a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnesses-including COVID-19-and inflammatory disorders. GOLDEN, Colo.–(BUSINESS WIRE)–Reven Holdings, Inc.
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