Dawn Niccum
Meet our Executive Vice President, Quality Assurance
How To Build Effective Clinical Trial Oversight And Leadership
Sponsor-led oversight is critical in clinical trials, even when strategic input and operational tasks are...Continue reading→
High-Velocity Development: Gene Therapy Vs. Small Molecule
Gene therapy development operates at a high velocity compared to small molecule therapies, with parallel...Continue reading→
Jenny Minigh
Meet our Executive Vice President, Medical Writing
Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
Discover why the science that brought you to this point can only take you so...Continue reading→
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→