CRO Products and Services

Quality Assurance

Investigative Sites Audit

  • We verify that the protocol is performed according to Good Clinical Practices (GCP) and International Commission
    on Harmonization (ICH) standards and the sponsor's or CRO-'s Standard Operating Procedures (SOPs).
  • Review the informed consent content and process
  • Review records and procedures concerning interactions with the IRB.
  • Review records and procedures concerning drug accountability
  • Inspect study-required facilities and equipment
  • We verify that the data collected in a representative sample of Case Report Forms (CRF-s) are supported by
    source documents.
  • Assess compliance with internal SOPs
  • Study documentation audit
  • Verify that the protocol is performed according to
    GCP and ICH standards.
  • Review records and procedures for site visits
  • Review study file documentation
  • Ensure internal systems used in the conduct of clinical
    trials are correct, including SOPs for Adverse
    Experience (AE) reporting, supplies distribution,
    and data handling.
  • Assess compliance with internal SOPs
  • Compare study report versus the protocol, CRF-s,
    and database.
  • Ensure internal consistency in reports
  • Preparation for regulatory inspection

    Covering:

    o Trial master file audits        o System audits         o Site audits
    o Central laboratory audits    o Data base audits     o Final clinical report audits