Is Your Clinical Trial at Risk: When to Consider a Rescue Strategy
Clinical trials rarely unravel because of one isolated event. Many continue to progress with underlying issues that gradually impact timelines, data quality, and overall study confidence. A missed...
From Feasibility to First Patient In: Streamlining Study Start‑Up with Confidence
Clinical trial timelines are rarely lost during study conduct but are lost long before the first patient is screened. Delays in study startup often begin at country selection and feasibility where...
Building Relationships with Sites: The Hidden Driver of Faster Start-Ups
Humanized content about engagement strategies with sites and investigators. The Study Start Up (SSU) phase of clinical trials always feels very chaotic when you are in the “thick of it” with...
Turning Regulatory Complexity into Predictable Study Start-Up Execution
Regulatory complexity is unavoidable in global clinical development. The differentiator is not whether organizations face complexity, it is how effectively they operationalize it. Across Europe,...
Regulatory Readiness as a Strategic Advantage in European Study Start-Up
For years, regulatory readiness was often viewed primarily as a compliance function, an operational necessity required to move clinical studies forward. Today, that perspective is no longer...
Five Metrics That Predict CRO Success (and How to Measure Them)
Selecting a contract research organization (CRO) is one of the highest-stakes decisions a sponsor makes during drug or device development. The right partner accelerates timelines, protects data...
Quality & Compliance
Operational Excellence in Global Clinical Research: Why Culture Drives Performance
Choosing a CRO Partner: Signals That Matter Most Operational excellence is often discussed as a performance outcome. Hit timelines. Stay on budget. Improve cycle times. Reduce deviations. Those...
Benefits of Site Support
Clinical research sites are carrying more responsibility than ever before. Staffing shortages, increasing protocol complexity, administrative burden and growing regulatory expectations place heavy...
The Role of CROs in Clinical Research & Clinical Trials
Clinical trials are complex, resource-intensive, and heavily regulated endeavors that span months to years. For many pharmaceutical, biotechnology, and medical device companies, navigating this...
Pros and Cons of Working with a CRO
A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract...
What is a Clinical Evaluation Report (CER)?
If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term 'CER' or Clinical...
Regulatory Sciences
Navigating Uncertainty with the FDA LDT Rule
On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for...
Navigating the Regulatory Maze: Clinical Data for Medical Device Approval
In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...
FSP Solutions
What is the FSP Model in Clinical Research?
The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and...
Meet the Expert: Terri Levine
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...
How Important is Biostatistics?
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...