The pandemic exposed the innovation divide between the digitally transformed and those that lagged. Strict regulation made life sciences and bio/pharma organizations hesitant to modernize too quickly away from proven legacy methods and technologies, resulting in varying levels of digital transformation. But since the pandemic, organizations now recognize the necessity of digitalization and smart automation…

Earlier this fall, the FDA detected potential issues in data generated by two contract research organizations (CROs). Specifically, the agency’s statement noted “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA.” Accordingly, the agency advised that all affected sponsor organizations repeat any bioequivalence and…