A compilation of recent notable news developments that pertain to the clinical trials industry.
Medable, Inc. has unveiled a multi-company research framework to accelerate development of diagnostics and treatments for COVID-19, providing individuals fast access to participate in leading-edge research for diagnostics, health monitoring, and interventional clinical trials. The ACCESS initiative-short for American COVID-19 Collaborative Enabling Seamless Science-provides a mobile consumer application and secure infrastructure to quickly connect health researchers and trial teams with up to millions of home-bound individuals in the U.S.
ACCESS makes it easy for individuals to contribute specific information about their COVID-19 experience, combine it with health records and data from wearable devices, and opt in to participate in current and future studies for diagnostics, treatments, and vaccines.
Trial technology company Clinical Ink has announced a wide-ranging Study Assurance Program to minimize financial impact of the disruption from COVID-19 on new and existing clinical trials. Contracting adjustments include change order waivers of all platform licensing and help desk fees for a period of up to three months for all current and new studies.
“This is a time to show that patients actually matter-it’s not just about money,” said Clinical Ink CEO Ed Seguine. “Clinical Ink is putting patients first by proactively waiving potentially millions of dollars in change orders so that new and current studies can continue without our customers having costs increase both now and in the long run. I invite other clinical technology and service providers to make a similar pledge so that our combined efforts can help ensure patients truly do come first.”
AUM LifeTech, Inc., a preclinical stage biotech company developing RNA therapeutics, and AUM BioTech, LLC, a genetic research startup, have jointly launched a research program called Knockdown Coronavirus with a goal of developing a treatment for COVID-19. Under this initiative, the two Philadelphia-based companies are offering self-delivering RNA silencing research products, powered by FANA ASO technology, to the global coronavirus research community to facilitate research and fast-track therapeutic development.
AUM LifeTech is currently working with collaborators on developing a treatment for COVID-19 AUM BioTech’s gene silencing research tools have the capability to selectively knockdown RNA of the virus. Further, its RNA targeting technology can be used to perform high-throughput genetic screening to identify the function of viral and host genes and help identify new targets for COVID-19 therapy development.
Advarra, a provider of institutional review board (IRB), institutional biosafety committee (IBC), research technology solutions, and quality and compliance consulting services has acquired IRB Company, Inc. (IRBco), an AAHRPP-accredited central IRB that has conducted research reviews in the U.S. since 1981. Advarra continues to expand its presence as the largest provider of integrated IRB services in North America.
- Staff and wire reports
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.