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What Is the FDA’s Clinical Trial Export Halt? Consent, Cell Use and Cross-Border Risks

XTalks

The FDA has paused new clinical trials that involve exporting Americans’ living cells to laboratories in countries deemed hostile, including China.

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Clinical Trial Outsourcing with Anca Copaescu

Clinical Trial Podcast

Anca and her team are helping biopharmaceutical companies plan and budget clinical trials, select and manage clinical trial suppliers, and contracts using software applications. Prior to her work at Strategikon, Anca served as the Sr.

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Modernizing Pharmacovigilance Outsourcing

XTalks

Companies outsource to gain access to specialized expertise and technology, scale pharmacovigilance (PV) activities, and reduce costs. However, the efficiency and effectiveness of externalized safety activities are below expectations for many biotech and pharma companies.

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Private equity firms play ‘pass the Parexel’ with $8.5bn handover deal

pharmaphorum

Four years after being taken private, Parexel has been sold again, with Goldman Sachs’ private equity arm and EQT paying $8.5 billion to claim ownership of the contract research organisation. billion.