Clinical Research Solutions
Meet the Expert: Philip Simonson
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
Value of Intentional Bias in GxP Vendor Audits
Discovering intentional bias in GxP Vendor audits: weighing its advantages, drawbacks, and strategies for effective mitigation. While the prevailing view suggests that GxP auditors should not be...
Clinical Research Solutions
Meet the Expert: Clarence Young
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
Clinical Research Solutions
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
Clinical Research Solutions
Meet the Expert: Brian Wellins
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
FDA Proposes Significant Changes to LDT Regulation
On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result...
Clinical Research Solutions
FDA Finalizes the Breakthrough Devices Program Guidance and Reinforces Innovative Medical Device Manufacturers that Help to Address Health Inequities
The FDA's Breakthrough Devices Program is intended to expedite the development of innovative technologies for patients with life-threatening or irreversibly debilitating diseases or conditions. The...
Clinical Research Solutions
Meet the Expert: Immaculich Rani
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
Single Arm Trials: How to Make the Future Brighter
Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...