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The Future of Clinical Trials: Decentralized Trial Considerations

Jan 30, 2023 | White Paper

Decentralized Clinical Trials (DCT) are here to stay! In 2007, the FDA and Duke University partnered to develop and drive the adoption of practices for increased quality and efficiency of clinical trials and formed Clinical Trials Transformation Initiative (CTTI)....

European Union Clinical Trials Regulation: Mandatory Deadline Approaching

Dec 20, 2022 | News

Since 2004, clinical trials in the EU have been controlled by the European Union Clinical Trials Directive (EU-CTD). The directive was an attempt to standardize rules and enhance patient protections in clinical trials; however, its real-life implementation created...

Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December

Dec 12, 2022 | News

Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December In Part 2 of this series, we discussed FDA’s first proposed rule, “Protection of Human Subjects and Institutional...

International Group ICH Offers Detailed Protocol Template For Clinical Trials

Nov 7, 2022 | News

In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design principles and approaches used to develop relevant documents for clinical...

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