Applied Clinical Trials-04-01-2017

Applied Clinical Trials

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.

News
Applied Clinical Trials

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.

News
Applied Clinical Trials

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?

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

Applied Clinical Trials
Clinical Trial Insights

April 01, 2017

Examining the evolution of protocol design and collaboration executing strategies.

News
Applied Clinical Trials

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.

Applied Clinical Trials
A Closing Thought

April 01, 2017

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

Applied Clinical Trials
From the Editor

April 01, 2017

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

Applied Clinical Trials

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

Applied Clinical Trials
Feature Article

April 01, 2017

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

Applied Clinical Trials

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

Applied Clinical Trials
Feature Article

April 01, 2017

How CROs and sponsors can step up their relationship game.

Issue PDF
Applied Clinical Trials

April 01, 2017

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