news roundup

BioIVT Joins FNIH's Biomarker Consortium

BioIVT, a global provider of high-quality biological specimens and value-added services, has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, a public-private biomedical research partnership that brings together members of industry, academia, nonprofit and patient advocacy organizations, and government agencies and institutes to develop and support research to qualify promising biomarkers.

BMS Chooses Concerto HealthAI for RWE in Oncology

Bristol-Myers Squibb will use Concerto HealthAI's Real-World Data and novel AI insights platform, eurekaHealth, in a multi-year strategic agreement covering a diverse range of cancers to advance the use of RWE for regulatory purposes, validate clinical application of AI solutions and execute clinical studies.

Forte Adds New Features to Onsemble Platform

Forte announced several new features to its Onsemble platform including comparative analytics and Trial Data Exchange that allows sites and sponsors to engage in data-informed conversations based on site operational data from within the platform.

Articles

FDA Moves Forward with Digital Health Device Pilot

In this article, DIA experts explain the FDA's progress on implementing its Software Precertification Pilot Program (Pre-Cert), which is intended to accelerate market entry of digital health devices by creating a process to establish confidence in the developer's capabilities to create and maintain digital health devices that meet the agency's standards for safety and effectiveness.

Managing Clinical Trial Complexity in the Gene Therapy Era

Advice for sponsors includes early and regular communications with regulatory authorities, as well as operational recommendations.

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Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com