How Do Regulatory Intelligence and Operations Envision Technology?
The shift from paper to cloud-based regulatory information management systems (RIMS) to address operations challenges.
News Notes
A compilation of recently released news briefs that pertain to the clinical trials industry.
Next-Generation Focus in Immuno-Oncology
How one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.
Labeling Challenges From EU Annex VI
A new era for clinical trials supply compliance in the EU is almost here.
Unleashing New Insights from Toxicology Studies
The long-running SEND initiative has fostered new FDA-industry partnerships, opening the door to dramatic changes in toxicology data analysis.
Overcoming Transportation Barriers to Trial Participation
Recruitment study tests the use of a ride-sharing service.
Applied Clinical Trials, December 2019 Issue (PDF)
Click the title above to open the Applied Clinical Trials December 2019 issue in an interactive PDF format.
It Costs What to Do That?
Some thoughts around the industry continuing to grapple with the high price tag associated with drug development costs.
Updates on Drug and Device Regulatory Reform in China
Outlining the nation’s key changes and current requirements in processing investigational and new drug applications.
Beyond Hard Outcomes: The Next Era in Heart Failure R&D
Why and how FDA is funding a digital biomarkers study that centers on quality of life for patients with heart failure.
Novel Strategies Advanced in 2019 to Inform Drug Development and Review
A view of the notable policy strategies advanced in 2019 to boost drug development and review.
How to Boost Research for New Antibiotics—And How Not To
Peter O’Donnell explores where the EU stands today in R&D pursuits for new antibacterial therapies.
Virtual Clinical Studies: Finding a Path to Execution
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.
Submission Considerations for Orphan Product Programs
Examining the unique aspects involved in preparing and submitting marketing applications for proposed treatments for rare disease.
Can Recruitment and Retention Get Any Worse?
Higher screen failure and patient dropout rates are raising the imperative to pilot and implement new study conduct models in trial recruitment and retention.
