L3 Clinical Trials CRO (L3), a division of L3 Healthcare, is a comprehensive Clinical Research Organization (CRO) focused on in vitro diagnostics (IVD) and medical device technologies. L3 has extensive experience in IVD and medical device clinical research, including point of care (POC) test devices, lab instrumentation and medical devices in cardiovascular care, oncology, infectious diseases and other diseases. L3 services support an entire clinical trial program from study concept to data analysis:
● Clinical Trial and Regulatory Strategy
● Market Research
● Study Protocol Development
● Statistical Analysis Plans
● Site Selection and Qualification
● Site Implementation and Training
● Clinical Trial Management
● Clinical Operations Oversight
● Data Management
● Regulatory Review and Filing
● Human Factors Testing
● CLIA Waiver
● FDA Submission and CE Technical Filing
● Publication Strategy and Implementation