In the News
Holding out hope
Stephen Peroutka talks about the challenges related to assessing and evaluating depression.
Applying for an EU marketing authorisation: A pharmacovigilance perspective
David Hillman and Clare Ryder outline the pharmacovigilance activities that a prospective marketing authorization holder will need to accomplish in advance of and throughout the application process.
FDA’s oncology clinical trial makeover
Pat Mann, Kirsten Messmer and Luis Arthur Pelloso provide an overview of new FDA guidances related to oncology drug development.
Wearables In clinical trials
Rob Petrie comments on some of the keys to the successful use of wearables in clinical trials.
Regulatory intelligence communication for business impact
Kirsten Messmer and Charity-Anne Schuller discuss how to maximize regulatory intelligence and offer best practices recommendations.
The CMC section of an EU IMPD: Considerations for US sponsors
John Watkins discusses investigational medicinal product dossier requirements for US sponsors planning to submit clinical trial applications in EU member states.
Understanding Leaching from Stoppers into Lyophilized Drugs
Steven Zdravkovic examines options for extractable and leachable studies to evaluate leaching from primary packaging into lyophilized drugs.
PPD signs exclusive agreement with China-based AI company
Niklas Morton explains how the new collaboration will help pharma companies create better optimized protocols that will prove to be more attractive to sites and investigators because they are tailored to their patient population.
PPD inks deal with China’s HLT to create data science-driven research solutions
The partnership will focus on data-driven feasibility, patient recruitment and real-world evidence offerings for both global and China-based pharma and biotech companies.
