Slow the Burn: How to Make Risk-Resilient Vendor Choices
Many pharmaceutical industry experts share similar principles for reducing financial risk when selecting an outsourcing...Continue reading→
What’s Wrong With My Trial? Uncovering The Root Cause Of Clinical Trial Troubles
Progress can be negatively impacted by clinical trials that hit obstacles. These challenges can be...Continue reading→
How to Establish Effective, Scalable Drug Safety Ops Across Multiple Vendors
Effectively managing drug safety operations across multiple vendors is crucial to ensure compliance with safety...Continue reading→
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 New Drug Application...Continue reading→
Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
Discover why the science that brought you to this point can only take you so...Continue reading→
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 assigning a single,...Continue reading→
Top 5 Considerations For CAR-T Trials During A Macroeconomic Downturn
Navigating CAR-T cell therapy trials during economic downturns requires strategic approaches to manage costs without...Continue reading→
Modernize TMF Culture to Better Support Modern Clinical Trials
The article focuses on the need to modernize Trial Master File (TMF) culture to better...Continue reading→
Identifying The Best People To Run A Clinical Study (And How To Hire Them)
The article emphasizes the importance of identifying and hiring top talent to run clinical studies,...Continue reading→
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 small and emerging...Continue reading→
What Big CROs Don’t Want You To Know About Staffing Scalability For Phase III Studies
The article addresses the hidden challenges of staffing scalability in Phase III studies, particularly when...Continue reading→
The Fallacy of the Corporate Memory Concept
The article challenges the concept of “corporate memory” within large CROs, arguing that while it...Continue reading→
Do You Take Comfort In Governance Agreements
The article delves into the limitations of governance agreements with large CROs, questioning their effectiveness...Continue reading→
Keys to Successful Risk Management in Clinical Trials
The article emphasizes the critical role of comprehensive risk management in clinical trials, especially as...Continue reading→
The Great Talent Misconception With Large CROs
The article examines the misconception that large contract research organizations (CROs) offer the best talent...Continue reading→
Natural History Studies in Gene Therapy Trials: Benefits, Timing and Execution
Natural history studies (NHS) in gene therapy trials are essential for understanding the progression of...Continue reading→
Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?
You wouldn’t hire a house painter to retouch fine artwork, so why would you contract...Continue reading→
A Prescription for Success: Treating Deficiencies in Employee Training and Mentoring
When rushed onboarding and inadequate training lead to costly mistakes, companies often lose more than...Continue reading→
How inSeption Unlocked the Secret to Repeatable, Scalable Low Turnover
This case study explores the evolution of a 10-year partnership and extrapolates the principles that...Continue reading→
Diverse Mentorship Models Create Multiple Paths To Employee Success
Mentorship models create multiple paths to employee success by fostering deeper, more enduring relationships than...Continue reading→
Quality Control in Medical Writing: What It Means and Why It Matters
Medical writing, particularly in the context of clinical regulatory and publications documents, necessitates applying effective...Continue reading→