Clinical Trials

iSpeak Blog
The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the...
InTouch
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
Features
The digital revolution is driving change across all industries. With its ability to increase transparency and trust between parties, the recent innovation called blockchain has the potential to significantly disrupt the clinical trials industry.
Training
This online training session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive...
Guidance Docs
The Introductory US Clinical Trial Materials Training Guide has been created to familiarize new investigational trial materials professionals by pulling together the terms and related information they need to be successful in their field.
Training
In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging....
Technical
One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal.3...