L3 is a proven CRO

We have decades of clinical expertise and experience in IVD and medical devices to help guide strategy and efficiently manage clinical programs. You may need full support or help with just a portion of your clinical study. L3 can accommodate your clinical research needs.

CRO services

L3 executes FDA and ICH compliant clinical trials to support 510(k), de novo 510(k), dual 510(k) and CLIA waiver by application and PMA submissions. Our contract research organization (CRO) experience and specialization uniquely positions L3 to provide high-quality clinical services using a streamlined approach and at competitive industry rates. 

Study preparation:

• Clinical Trial Strategy
• Study Protocol Development
• Trial Master File Development
• Site Identification, Qualification & Selection
• Contracts & Budgets
• IRB Preparation & Submission 
• Statistical Planning
• Data Management Development

Study enrollment:

• Site Initiation & Training
• Clinical Trial Management
• Clinical Data Monitoring
• Site Management
• Trial Master File Management
• Invoicing / Billing
• Data management (including electronic data capture (EDC))

Study completion:

• Statistical analysis
• Site Closeout
• Clinical Study Report

Why work with L3? 

• Experts in IVD and medical devices
• Specialized study resources and services
• Strong network of clinical researchers and sites
• Efficient and cost-effective clinical trial management
• Senior team support throughout your project