Central lab (safety tests, biomarkers, PGX and PK tests)
Sample Collection and Sample Transportation are key issues in ensuring safety and efficacy data is available for analysis. It will be important for the CRA to review the collection and packing process for the samples at the Site Initiation Visit, discuss the importance of the site obtaining the necessary quantities required for analysis, and ensure the site knows the timeframe and method for each PK sample collection and sample shipment. Fountain recommends all samples be shipped to a central lab and dispersed to associated specialty labs on a pre-determined timeline. Simplifying processes at the site level decreases the potential for error.
FMD is able to offer central lab services by partnering with CAP certified labs. Our partners have analyzed many samples for pivotal global clinical studies and generated data for filings at the US FDA and EU EMA.
Analytical capabilities include:
• High throughput bioassays
• Routine clinical tests
• Chemistry & toxicology
• Methodology evaluation and validation
• Sample storage & management
Clinical Trial Design and Protocol Development
Medical Writing (Protocols, IB’s, Clinical Study Report, annual safety reports, etc.)