Services

Poulton Quality Solutions can offer a wide selection of Global Clinical QA services.  These include, but are not limited to:


GCP Auditing:

  • CRO GCP Systems
  • Internal Systems
    • Serious Breach Process
    • Pharmacovigilance Reporting Process
    • Sponsor Oversight Process
  • Investigator Site Audits
  • Laboratory
    • Local
    • Central
    • Bioanalytical
    • Specialist
  • Bioequivalence studies and services
  • Computer System Validation (CSV)
  • Interactive Response Technology (IRT) Systems
  • Electronic Data Capture (EDC) Systems
  • Electronic Patient Reported Outcomes (ePRO) Systems
  • Document Management Systems
  • QMS GAP Analyses
  • Documentation – including: Protocol, Patient Information Sheet / Informed Consent Form (PIS / ICF), Case Report Form (CRF), Investigator Brochure (IB), Clinical Study Report (CSR), Development Safety Update Report (DSUR)

GLP auditing of GLP laboratories


GMP auditing of oral solid dosage forms


Training:

  • ICH GCP
  • Clinical Trial Regulations & Guidelines
  • Inspection Preparation
  • CAPAs and Root Cause Analysis
  • Digital Quality
  • Trial Master File/Essential Documents

Inspection Training and Support:

  • Mock EMA, MHRA or FDA GCP Inspection
  • Facilitation during an Inspection
  • Assistance in Inspection response preparation

Clinical QA Consultancy

  • Project designed to suit your specific requirements