The U.S. FDA selects Icon to validate three patient-reported outcome (PRO) instruments used to assess clinical endpoints in antibacterial drug trials.

A recent study by German researchers found that postmarketing trials funded by the industry are not effective in identifying safety issues.

Parexel has launched an expanded Managed Access Programs service to streamline patients’ access to compassionate use of investigational medical products.

CRO SynteractHCR has announced another glut of appointments after last year’s acquisition from U.S. healthcare equity firm Amulet.

The European Parliament is calling for a shake-up in legislation to make it harder for pharma companies to duck obligations on testing medicines in children.

The European Medicines Agency has started a review of medicines whose studies have been conducted at either of the two sites of Micro Therapeutic Research Labs…

The European Medicines Agency recently held a workshop with stakeholders about adaptive pathways, which also allows more real-world data into drug approvals.

Martine Dehlinger-Kremer, VP of global medical and regulatory affairs at SynteractHCR, was elected president of the European CRO Federation, which represents…

The 21st Century Cures Act has already passed both section of the Congress, but several proposed changes to the clinical research and drug approval process…

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