Consulting Services

CGI has extensive expertise in implementing pharmacogenomics and biorepositories for clinical trials. Our team has implemented GLP and CLIA studies for biotech and pharma companies and has been involved in writing voluntary genomic data submissions and clinical protocols. Clients can benefit from 10 years of experience at the cutting edge of PGx testing by working with CGI experts to plan new studies, troubleshoot assays or study designs, interpret data, etc. Clients frequently ask for guidance in the following areas:

  • Pharmacogenomics Implementation
  • Clinical Trial Design
  • Informed Consent Assay Development
  • Assay Development
  • Technologies for Pharmacogenomics
  • GLP/GCP/CLIA/ISBER regulations
  • Quality Systems
  • Regulatory Compliance
  • Sample Shipment
  • Sample Logistics
  • Sample Handling and Storage


Advantage of Using CGI’s Consulting Capabilities

  • Expertise in developing validated pharmacogenomic assays to support all phases of clinical trials
  • Extensive experience with regulatory agencies in the U.S., E.U., and Japan
  • Seamless integration with CRO partners
  • Recognized thought leaders with extensive domain expertise
  • Solid history of successful engagements with top pharma and biotech companies