Clinical Study Design

Fitzgerald Clinical Research knows that the quality of design in a clinical research study can make or break its future success. We will help you develop novel methods to accelerate the conduct of your studies adhering to globally consistent quality standards for patient safety and regulatory guidelines. Strategic analysis and decision-making are vital in drug and device development.

In today’s regulatory climate, agencies demand efficient methodologies to improve the quality of data. At FRC, we’re poised to meet this paradigm shift through Risk-Based Monitoring (RBM). We’ll evaluate each study holistically to ensure the right organizational structure is deployed to support central and on-site monitoring.

When you work with FRC, you will have a single point of contact to define study objectives and create concrete measurements based on your unique needs. Our customized, data-driven approach is designed to meet your start-up process requirements.

We can design clinical development plans with proactive solutions to regulatory issues with achievable timelines. Our dedicated specialists will map the customer and patient journey to develop user-centric programs with informative, up-to-date data.

Talk to us about your needs.

Clinical Study Design Services
Protocol/Protocol Amendments
Statistical Methodology
Investigator Brochure/Updates
Package Inserts