
The latest version of the Prescription Drug User Fee Act has sponsors and FDA officials pressing for Congressional action regarding the program’s provisions accelerating the drug development and application review processes.

The latest version of the Prescription Drug User Fee Act has sponsors and FDA officials pressing for Congressional action regarding the program’s provisions accelerating the drug development and application review processes.


Veeva Systems announced the future release of Veeva Vault Submissions Publishing, a cloud application that incorporates publishing capabilities within Veeva Vault RIM to speed regulatory submission delivery.


Montrium announced the release of the Regulatory Navigator, an interactive intelligence dashboard integrated into the company’s RegDocs Connect, a Regulatory EDMS solution.

The war on cancer has seen significant strides made in the search for a cure, however, recent data suggests that the work is far from over.

When designing and using an electronic informed consent form, there are many factors that should be considered when applying to clinical research.



Almac Group has announced the launch of their temperature management software TempEZ, the first offering from Almac’s “Next Generation Temperature Management Portfolio”.

PAREXEL has announced the acquisition of The Medical Affairs Company, a provider of outsourced medical affairs services to the pharma, biotech and medical device industries.

The temptation to use uncontrolled, early, small studies to support further development of products may prove problematic for emerging biopharma companies.


OmniComm Systems and MediStat have collaborated to expand their life sciences market presence in Israel.


Study finds that financial links between researchers and drug manufacturers are independently associated with positive trial results.

Q&A explores the evolution and challenges of new technology implementation in clinical trials.

Recent studies may help break down barriers to implementing patient-centric initiatives.

Reaching the point of seamless integration of patient-care options won't be easy, but you can visualize how to get there through the prism of the "Clinical Trial of Tomorrow/"

A how-to guide for clinical trial managers in implementing patient-centric approaches using today’s clinical study model.

How the adoption of electronic clinical outcome assessment in trials can drive increased communication and patient reporting of events.

A look at the unique compliance and patient safety hurdles-and subsequent interventions-for resource-limited trial sites with no prior experience.

Highlighting the six broad technology themes poised to transform future R&D.

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


iCardiac Technologies has announced the launch of its Direct-to-Subject Pre-Coaching video tool.

The European Union effort to forge more cooperation among its national and regional HTA bodies is still a work in progress, as the process has produced varying views on the subject.

As part of its collaboration on type 2 diabetes with the University of Oxford in the U.K., Novo Nordisk is investing 1 billion Danish kroner over the next 10 years in a new research center.


PPD has announced the opening of a new clinical research unit for conducting Phase I and early development research in Las Vegas, Nevada.