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Redefining clinical trials: Adopting AI for speed, volume and diversity

IBM Big Data Hub

The FDA, in its May 2023 draft guidance, backed the adoption of DCTs across drugs, biologics and medical devices , highlighting their merits such as enhanced patient convenience, diminished caregiver burden, broader access to varied demographics, amplified trial productivity, and support for research on rare or mobility-restricted patient groups.

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EU: NIS2 enters into force

DLA Piper Privacy Matters

On 16 January 2023, the Directive on measures for a high common level of cybersecurity across the Union (“ NIS2 ”) entered into force. Management bodies of essential and important entities will have to approve these cybersecurity risk management measures, supervise their implementation and be liable for non-compliance by the entity.