Pharmaceutical Executive December 17, 2024
Mike Hollan

Regulatory, technological, and other factors are set to have a significant impact in the coming year.

The clinical trial landscape is on the brink of transformation in 2025, driven by groundbreaking shifts in regulation, technology, and collaboration. The convergence of new industry guidelines, increasing operational complexity, and the pressing need for innovation is reshaping how the industry approaches biospecimen management, compliance, and tech adoption.

Among the most significant changes is the European Union’s leadership in implementing the ICH E6(R3) guidelines. These updates emphasize data integrity and traceability, setting new benchmarks for quality that reflect the increasing complexity of protocols while signaling a growing need for industry collaboration. Going into the new year, we now find ourselves with an incredibly unique...

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