CRAs Must Evolve Alongside Oncology Therapeutics
Clinical Research Associates (CRAs) must adapt to the evolving demands of oncology therapeutics, which require...Continue reading→
Crissy Reynolds
Meet our Senior Director, Regulatory Operations
Raul P. Lima
Meet our Executive Vice President, Clinical Operations
Karin Rezzonico
Meet our Senior Director, Quality Assurance & Compliance
Our message to CMOs
For over 12 years, we’ve stood alongside the Chief Medical Officer Summit 360°, championing the...Continue reading→
FDA Update on ICH E6, E8, QbD and RBM in Clinical Trials
Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) approaches in clinical trials enhances efficiency...Continue reading→
Revolutionizing Clinical Trials: The Power And Potential Of Risk-Based Monitoring
The article explores the benefits and misconceptions of risk-based monitoring (RBM) in clinical trials, emphasizing...Continue reading→
How Sponsors and Patients Benefit From a Site-Centric Partnership
Site-centric partnerships between sponsors and clinical trial sites can significantly enhance patient and personnel support,...Continue reading→
Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?
Evaluating the suitability of multitherapeutic contract research organizations (CROs) for clinical trials is crucial, as...Continue reading→
Successful Regulatory Submission Via the Trifecta of Awesomeness
The article discusses the key elements that lead to a successful regulatory submission: strategic planning,...Continue reading→
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→