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Services

Fitzgerald Clinical Research provides a full suite of services to help our sponsors bring new drugs and devices to market, safely, on-time and on budget. Our proven track record and attention to detail facilitate the highest quality data collection possible. Our pro-active philosophy and adherence to the most rigorous scientific guidelines ensure that your study will achieve compliance.

Central to our work is the knowledge that people are in desperate need of better medical care, and that this driving force fuels the mission to uncover new medicines and medical appliances. Bringing medical breakthroughs to market is a high-risk, resource-intensive task to which we lend our supporting expertise.

From study design to implementation,  we are able to partner with sponsors to expertly conduct your research, providing effective project management from proof of concept through post-approval. We can support FDA submissions and give regulatory guidance. In addition, we are expert at managing Trial Master File documentation.

We are solution-focused and effectively deliver high-quality clinical research. Please review our services and Contact Us for a confidential review of your research.

Clinical Study Design
Protocol/Protocol Amendments
Statistical Methodology
Investigator Brochure/Updates
Package Inserts
Clinical Study Planning
Budgeting
Selection of vendors
Site Selection/Documents
Clinical Study Oversight
Development and/or Review of Study Plans and Logs
Data Management Systems Design
Data tracking
Statistical analysis review
Clinical study report
Trial Master File Set-Up
Review of all TMF Documents
FDA Support
Briefing Documents review
FDA meetings
Briefing Documents
Investigator Brochure
Annual Reports