Perspectives
perspectives
February 13th, 2025
Helping European Drug Development Companies Succeed in the US Market
perspectives
November 12th, 2024
REMS Logic Modeling: Applying FDA Guidance from November 2024 CDER Webinar
perspectives
September 30th, 2024
The Future of Data Management and Biostatistics: Trends and Technologies Shaping the Industry
perspectives
September 11th, 2024
From Historical Precedent to Modern Approvals: Lessons Learned on OTC Drug Products for FDA OMORs
perspectives
July 30th, 2024
The Critical Role of Quality Control (QC) – Medical Writing and Beyond
perspectives
July 23rd, 2024
PSI 2024 Ignited Conversations on External Data Sources, Requirements for Estimands, and Bayesian Methodology for Statisticians in Pharma
perspectives
July 16th, 2024
Key Steps to Successful CMC Authoring of IND and IMPD Submissions
perspectives
July 9th, 2024
Managing RTOR Submissions: How to Run a Successful Race from the Top Line Starting Line
perspectives
July 2nd, 2024
Part 1: RWD Noninterventional Study Design and FDA Engagement Opportunity for Early Stage Oncology
perspectives
June 21st, 2024
Peer-Reviewed Journal Articles: The Crucial Role of Publication in the Pharmaceutical Industry
perspectives
June 14th, 2024
A Structured Approach to Benefit-Risk Assessment Throughout Product Development in the Pharmaceutical Industry
perspectives
June 6th, 2024
Datacise and Diversity in Patient Enrollment: Combining Geospatial and Demographic Data to Aid Site Selection