Navigating the new Clinical Trial Regulation with DIA
For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will have a dramatic impact. The aim of the change in regulation is to increase the efficiency of all trials in Europe, as well as promoting research while avoiding the duplication of clinical trials
Case Study: Cmed’s Mobile Data Management Solution
The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
Outsourcing in clinical Trial Medical Devices Europe 2018
7-8 February 2018, Munich, Germany
Outsourcing in Clinical Trials: Medical Devices Europe has now reached its fifth birthday. This event is focused on Medical devices. At this event you will learn about the new regulations, which were released this may, regarding medical devices in more detail, from speakers who are the heads in their respective fields.