Perspectives
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
perspectives
May 29th, 2024
Confined Deferrals in Clinical Trial Applications: Anticipating the Revised EU CTR Transparency Rules
perspectives
May 21st, 2024
Psychedelics and Regulatory Considerations Part II: A Shift in Lexicon and Implications of “Nonmedical Use” On Labelling
perspectives
May 10th, 2024
Psychedelics in Drug Development and Regulatory Considerations Part I: Benefit-Risk
perspectives
April 29th, 2024
Validation of Clinical Dashboards for Decision Making