news roundup
The CRO, founded in 1985, launched its Initial Public Offering and is being traded on the Nasdaq as PPD.
The Almac Group’s Label Approval Solution (LAS) seeks to optimize all clinical label development processes, with project management teams and supporting centralized technology.
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AI in Action: Clinical Development AI Use Cases
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Synteract has acquired Clindata’s human health biometrics division, which further extends Synteract’s existing global footprint into Asia Pacific and Africa, and offers another core biometrics services hub, complementary to those it operates in Europe and the U.S.
Articles
In this article, the authors discuss the recently launched Clinical Trials Transformation Initiative’s (CTTI) multi-stakeholder decentralized clinical trials (DCT) project, to help identify perceived and actual legal, regulatory, and practical barriers to conducting DCTs and identify opportunities to clarify and inform policies that affect the implementation of DCTs.
In this article, the author describes the unique aspects of rare disease drug development programs, which then affect the preparation and submission of the marketing application—a new drug application (NDA) or biologics license application (BLA)—to FDA.
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Advances in RBM Drive the Clinical Trial of the Future
Access an online resource with useful tools and practical information about advances in RBM. The site provides useful white papers, articles, webcasts, and more.
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Blog Posts
Along with the FDA’s first step to grant Emergency Use Authorization for the CDC to distribute a new coronavirus diagnostic, permitting qualified laboratories around the country to use the test, companies including Regeneron, Gilead, J&J and GSK announced initiatives around the coronavirus vaccine.
FDA’s new commissioner, Stephen Hahn, MD, a prominent oncologist and top official at the MD Anderson Cancer Center in Houston confirmed by the Senate in December 2019, appointed Anand Shah as deputy commissioner for medical and scientific affairs, as well as new senior advisors include Colin Rom and attorney Lowell Zeta.
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