Regulatory compliance: how CROs keep clinical trials aligned with regulations

by Sermes CRO

What happens when a clinical trial fails to comply with regulations? Fines, delays, and loss of credibility are just the tip of the iceberg. In a sector where patient safety and scientific integrity a...

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Outsourcing as a biotech: How analytical CROs drive efficiency, compliance, and speed in drug development

by AMSbiopharma

Outsourcing analytical development, more than a cost-saving mechanism, has become a strategic lever that shapes data quality, regulatory confidence, and development speed. When aligned correctly, anal...

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Successful Rescue and Accelerated Restart of a Clinical Trial for NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

by Pivotal

A multi‑country oncology study regained momentum through structured transition planning, seamless cross‑functional collaboration and decisive operational oversight, regulatory recovery, and discip...

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Nueva guía de la EMA para la gestión de ensayos clínicos en emergencias sanitarias

by Sermes CRO

Las crisis no deben paralizar la investigación, pero tampoco justificar atajos que pongan en riesgo a los participantes o la validez de los resultados. Este es el leit motiv de la nueva guía de la E...

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Navigating EU-UK Dual-Track Clinical Trial Regulation in Parallel

by Pivotal

How sponsors can leverage both the EU Clinical Trials Regulation and UK’s reformed framework to achieve cost efficiencies, faster timelines, and stronger regulatory positioning.

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Impact of financial compensation on patient recruitment and retention in clinical trials

by Sermes CRO

In the day-to-day conduct of clinical trials, one of the factors that most strongly affects patient recruitment and retention is not the scientific design of the protocol, but rather the indirect fina...

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