Applied Clinical Trials-12-01-2019

The shift from paper to cloud-based regulatory information management systems (RIMS) to address operations challenges.

A compilation of recently released news briefs that pertain to the clinical trials industry.

How one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.

A new era for clinical trials supply compliance in the EU is almost here.

The long-running SEND initiative has fostered new FDA-industry partnerships, opening the door to dramatic changes in toxicology data analysis.

Recruitment study tests the use of a ride-sharing service.

Click the title above to open the Applied Clinical Trials December 2019 issue in an interactive PDF format.

Some thoughts around the industry continuing to grapple with the high price tag associated with drug development costs.

Outlining the nation’s key changes and current requirements in processing investigational and new drug applications.

Why and how FDA is funding a digital biomarkers study that centers on quality of life for patients with heart failure.

A view of the notable policy strategies advanced in 2019 to boost drug development and review.

Peter O’Donnell explores where the EU stands today in R&D pursuits for new antibacterial therapies.

The regulatory path for virtual studies is nebulous and potentially difficult to navigate-finding a way forward requires a thorough understanding of the terrain and how to apply existing legal frameworks.

Examining the unique aspects involved in preparing and submitting marketing applications for proposed treatments for rare disease.

Higher screen failure and patient dropout rates are raising the imperative to pilot and implement new study conduct models in trial recruitment and retention.