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news roundup
The Senate has voted to confirm a new FDA Commissioner, Stephen Hahn, MD. Hahn comes to FDA from the MD Anderson Cancer Center in Houston, where he was chief medical officer.
Almac Clinical Technologies, a member of the Almac Group, has launched its Interactive Response Technology (IRT) platform—IXRS 3 with Exostar’s Identity and Access Management Platform. The two global companies first announced a pilot partnership in December 2016 to demonstrate a proof-of-concept for eClinical application users to benefit from Exostar’s industry-leading Single Sign-On (SSO) expediency and enhanced enhanced security.
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Managing Signals in the Modern Pharmacovigilance Landscape
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WCG ACI Clinical has launched the latest iteration of its proprietary AIMS (Adjudication Information Management System) platform, AIMS 4.1. The new version features an enhanced interface and workflow experience.
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Anti-Microbial Resistance and the Role of Vaccines
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Articles
Recently, the National People’s Congress of China approved further revision to China’s Drug Administration Law (DAL) to rationalize the infrastructure of drug administration and consolidate the remarkable outcomes obtained in recent years in China.
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AI in Action: Clinical Development AI Use Cases 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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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
Tufts CSDD and The Avoca Group recently released the results of its Benchmarks for the Vendor Qualification Process and Ken Getz, professor and deputy director of Tufts CSDD, shared at the Clinical Trials Europe event in Barcelona last month that $375 million is how much sponsors spend yearly on the request for information (RFI), new vendor qualification, and vendor requalification process for outsourced activities.
Doug Manion, CEO of Kleo explains the emergence of platform technologies in the biopharma industry, which in Kleo’s case, involves the engineering of antibodies and biologics using linear process chemistry to enhance drug effectiveness.
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