As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (patients and others not in ...
Rossen Mihaylov at Ramus Medical discusses the challenges faced during the preparation and conduct of clinical investigations. For both medical drugs and devices, CROs face a variety of regulatory and scientific challenges, provoking different initiatives for managing and balancing them. ...
The major objective of pharmaceutical research & development is to bring new health solutions to people who need them. Lionel Bascles and Victoria (Vicky) DiBiaso at Sanofi discuss how Sanofi has made progress each year in delivering increasingly accelerated drug ...
Clinical trials are becoming increasingly complex, particularly with broader scopes, globalisation, changing and expanding regulatory requirements and a greater number of players, such as contract research organisations (CROs), sites, laboratories and vendors. Lorie McClain at Bioclinica discusses the consequences of ...
The first-in-human trial (FIH) is an important milestone in the development of a potential new drug. Nariné Baririan at SGS discusses how going ahead with something that will, in all likelihood, fail is a waste of time and money that ...