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Regulatory Requirements General Data Protection Regulation (GDPR) False Claims Act (FCA)

Gardner Law

Effective Clinical Trial Agreements: What You Need to Know

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Clinical trial agreements (CTAs) form the foundation of any clinical research initiative, establishing the legal and operational framework essential for a study's success. Crafting, reviewing, and negotiating CTAs require...more

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FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

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When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

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