Brief Introduction to the CT Regulation. Several years after enactment, the Regulation EU/536/2014 governing clinical trials with medicinal products in the EU eventually became applicable on 31 ...

UK & Ireland, experts provided insights on market trends within the clinical trial industry and advice on engagement ...

In a more challenging regulatory environment for clinical trials, optimising trial designs early makes success more likely.

A panel at OCT Europe touched upon where the European clinical trial industry is headed and the impact of technology and regulations.

That is what clinical development groups know best; they have systems in place and they're confident about the regulations that govern trials. In contrast, a MAP has different rules and regulations.

An Emergency Shortage Of Clinical Trial Investigators. The number of clinical trials increased by 118% from 2010 to 2015 and by 80% from 2015 to 2020.Yet the pool of investigators hasn’t grown ...

Such regulations do not lend themselves to the flexibility needed to enable community-based research, where patients can receive clinical trial services in many types of settings. Consistently ...

Meanwhile, the TGN 1412 debacle, which ultimately led to revisions in British guidelines for clinical trials and tightening of regulations surrounding phase 1 studies, “certainly woke people up to the ...