With sponsors of decentralized clinical trials increasingly getting involved in contracting third-party vendors to deliver services that are traditionally overseen by investigators, a much-awaited EU recommendation paper will explain how both parties can maintain control over their distinctive roles.
The upcoming pan-EU recommendation paper on decentralized clinical trials (DCTs) will offer guidance on the tricky subject of how sponsors and investigators can demonstrate control over their respective responsibilities in such studies.
The problem arises because in DCTs – in which certain trial activities are conducted remotely and in, or near, participants’...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
