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Labs
Providing customized, high-quality laboratory services in all stages of drug development
Overview

Comac Medical’s laboratories use state-of-the-art equipment and are GCP and GLP compliant. Our labs have responsive teams of experts which work with innovative methods to bring timely, high-quality services.

Laboratory Expertise:
Central Clinical Laboratory
  • Wide range of technologies and applications (Hematology, Clinical and Special Chemistry, Immunology, Microbiology, Biomarkers assessments)
  • Preparation of Laboratory Manuals
  • Preparation of laboratory kits and patient forms
  • Sample handling, management and storage
  • Flexible logistics services
  • Shipment Monitoring
  • Investigator support
  • Dedicated laboratory project management
  • Data export capabilities (incl. in STDM compliant format)
Bioanalytical Laboratory
  • Regulatory method development and validation (small and large molecules)
  • Expertise in different analytical techniques (LBA and LC-MS/MS)
  • Expertise in “Fit For Purpose” validation for early phase clinical studies and biomarkers
  • Association with industry advisory groups
  • GCP and GLP compliance
  • Lab data transfer (incl. SDTM format)
  • Immunogenicity analysis
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