Almost every company and non-profit working on COVID-19 that I offered to help asked for support with clinical trials—for companies focusing on developing novel drugs, vaccines, and diagnostics, rapidly spinning up trials is one of their biggest bottlenecks.
Science remains the only way out of the COVID-19 crisis. Dramatically improving clinical trials, which are usually time-consuming and cost tens to hundreds of millions of dollars, is one of the highest-leverage ways to get out of it faster.
The goal of this project, in collaboration with TrialSpark and Dr. Mark Fishman, is to offer much better clinical trial support to COVID-19 projects than anything that currently exists.
Project Covalence’s platform, powered by TrialSpark, is uniquely optimized to support COVID-19 trials, which are ideally run in community settings or at the patient’s home to reduce the burden placed on hospitals and health systems. Project Covalence is well-positioned to tackle the operational and logistical challenges involved in launching such trials, and supports trial execution, 21 CFR Part 11 compliant remote data collection, telemedicine, biostatistics, sample kits for at-home specimen collection, and protocol writing.
Researchers across academia and industry can leverage this shared infrastructure to rapidly launch their clinical trials. To facilitate coordination between studies, we will also be creating master protocols for platform studies to enable shared control arms and adaptive trial designs.