Applied Clinical Trials-04-01-2017

April 01, 2017

The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.

April 01, 2017

The European Forum for Good Clinical Practice to examine the impact of current regulations and areas such as big data and quality management on so-called complex studies.

April 01, 2017

Is the much anticipated Europe action plan on personalized medicines, unveiled recently by an EU-sponsored international consortium, worth paying a close eye on?

April 01, 2017

Application review will require closer cooperation between ethics committees and competent authorities in several areas.

April 01, 2017

Examining the evolution of protocol design and collaboration executing strategies.

April 01, 2017

The implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.

April 01, 2017

The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.

April 01, 2017

Why following one consistent playbook for trial management should be at the core of outsourcing partnerships in drug development.

April 01, 2017

How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.

April 01, 2017

Examining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.

April 01, 2017

Outlining current regulatory issues and views surrounding expanded access to investigational products in the U.S.

April 01, 2017

How CROs and sponsors can step up their relationship game.

April 01, 2017

Click the title above to open the Applied Clinical Trials April/May 2017 issue in an interactive PDF format.