News

The mutual recognition agreement between the European Union and the US FDA now covers 15 European countries, after Portugal won US recognition in mid-September.

This article will summarize the discussion on innovation that took place at this years Cambridge Health Institute’s Clinical Trial Innovation Summit.

These seven key building blocks for success are outlined to help companies develop and implement a data-and-analytics-driven approach to clinical trial feasibility.

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.

The critical need for new medicines to combat infectious diseases is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to promote innovation in this area.

This article will focus on a case study example of a collaborative effort to share investigator, site, and study information across companies, and on the single data model that underpins it.

Krista Armstrong explains the CRO's evolving role within clinical trials.

Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.

Updated employee announcements, business news, awards, and recognition in the industry today.

The workings of the European Union are notoriously complicated, with the result that misunderstanding is commonplace, even among those who might like to know more about it.

There have been a number of significant scientific and regulatory milestones driving the adoption of electronic patient-reported outcomes in clinical trials since the first screen-based ePRO solution, Minidoc, appeared in 1980.