An eagerly-anticipated group has been set up in the EU to hold balanced discussions with multiple stakeholders on how to solve clinical trial-related issues.
A much-awaited advisory group tasked with resolving clinical trial-related issues in the EU that sponsors, regulators and other stakeholders might face is up and running, following the appointment of the group’s second co-chair.
Denis Lacombe, chief executive officer of the European Organisation for Research and Treatment of Cancer (EORTC), was appointed as the...
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
