CyberActa reposted this
Data products have to designed, built, and maintained with the needs and requirements of its users in mind, just like a traditional product. By treating clinical data as a product, sponsors can stimulate a culture of data sharing and reuse under appropriate circumstances, which breaks down data silos and promotes cross-functional collaboration. This product orientation ensures that data is properly managed and governed, with clear accountability, quality, and access controls. Over time it will improve operational and analytical data quality, reduce data backlogs, lower data storage costs, and reduce data redundancy. These improvements will allow your organization to better leverage their data products and make more effective, data-driven decision-making. #data #transparency #clinical #sponsors #GCP Veridat
For the first time since 2006, the #FDA has proclaimed its broad expectations for the scope of oversight, conduct, and practices of a data monitoring committee (#DMC) in a new draft guidance. The public comment period ends April 15, 2024. https://lnkd.in/e9FGC4gU By John Giantsidis, president, CyberActa. and Remco Jan Geukes Foppen, Ph.D. #datamonitoring
