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How to Establish Effective, Scalable Drug Safety Ops Across Multiple Vendors
Effectively managing drug safety operations across multiple vendors is crucial to ensure […]
Read More....Second Time’s The Charm — Navigating NDA Submission, Plus A Resubmission Rescue Mission
The article outlines the challenges faced by a biopharmaceutical company during its […]
Read More....Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
Discover why the science that brought you to this point can only […]
Read More....Why the Regional Site Manager Is the Swiss Army Knife of Clinical Trial Monitoring
The Regional Site Manager (RSM) monitoring model enhances clinical trial oversight by […]
Read More....Modernize TMF Culture to Better Support Modern Clinical Trials
The article focuses on the need to modernize Trial Master File (TMF) […]
Read More....Great Size ≠ Great Value: How Smaller Outsourcing Partners Benefit Small And Emerging Biotechs
The article highlights the advantages of partnering with smaller outsourcing firms for […]
Read More....Natural History Studies in Gene Therapy Trials: Benefits, Timing and Execution
Natural history studies (NHS) in gene therapy trials are essential for understanding […]
Read More....Quality Control in Medical Writing: What It Means and Why It Matters
Medical writing, particularly in the context of clinical regulatory and publications documents, […]
Read More....How Sponsors and Patients Benefit from a Site-Centric Partnership
Creating a site-centric partnership between a pharmaceutical/biopharmaceutical sponsor and a clinical trial […]
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