Information Technology Services

Our team of IT experts can help your company select, implement and validate computerized systems for GXP compliance. We can:

  • Audit your IVRS vendors
  • Provide software validation support
  • Create a validation project plan
  • Create a User Acceptance Test (UAT) protocol
  • Test cases to verify the elements of the system requirements
  • Create a Traceability Matrix linking test cases to specifications
  • Create a Validation Summary Report
  • Provide a Certificate of Release for production use
  • Analyze data during and after your clinical trial

IVRS

Our IVRS auditors have extensive computer system, IVR systems, and validation experience. They can review and assess your IVR contractor for adequate experience and sophistication in handling distribution of Clinical Trial Materials. Assessment will include:

  • IVR set-up procedures
  • IVR specifications (including complex designs)
  • IVR UAT and Change Management
  • Drug supply management planning and optimization:
    • Kit designs
    • Depot/sub-depot stocks (buffer stock and resupply levels)
    • Site stocks (buffer stock and resupply levels)
    • Accountability/returns
      • IVR Vendor Management
        • To include vendor audit(s), if required
      • Code break procedures
      • Study close-out procedures
  • Industry standard best practices with recommendations to improve procedures


CROs housing database and electronic Trial Master File (TMF)

Our auditors can assess your CROs for the following in addition to other protocol specific items:

  • CRO housing database and performing statistical analysis of study data
    • Review of Quality System
    • Review of training records and staff qualifications
    • Review of database setup and validation procedures and documentation
    • Review of data management procedures
    • Review of statistical analysis procedures
    • Data center facility tour
    • Review of IT procedures
  • CRO housing electronic TMF
    • Review of Quality System
    • Review of training records and staff qualifications
    • Review of system and validation documentation for eTMF
    • Review of eTMF setup, management and archiving procedures
    • Data center and document storage facility tour
    • Review of IT procedures

Address :

6 Jacobs Lane
Scotch Plains, New Jersey 07076