QC2 Services

QC2 offers a wide range of audit, standard operating procedure (SOP), training, and consulting services.

GCP Audits

  • Investigator Site Audits
  • Phase I Facility and Study Audits
  • Institutional Review Board (IRB) Audits
  • Essential Documents / Trial Master File (TMF) Audits
  • Electronic Trial Master File  (eTMF) Audits
  • Clinical Study Report (CSR) Audits

GLP Audits

  • Toxicology Facility and Study Audits
  • Formulation Analysis and Bioanalysis
  • Pathology Evaluations including Contracted Reading Vendors

Bioanalytical Laboratory Audits (GCP and GLP)

  • Large and Small Molecules
  • Biomarkers

Clinical Pathology Laboratory / Central Laboratory Audits

  • Safety Panels
  • Flow Cytometry
  • Molecular Diagnostics
  • Cell-Based Assays
  • Specialty Diagnostics

Sponsor Audits, CRO Audits, and Vendor Audits

  • Clinical Operations  Audits
  • Data Management and Biostatistics Audits
  • IVRS Audits and IWRS Audits
  • Central Reading Center Audits
  • Electronic Data Capture (EDC) and Remote Data Capture (RDC) Audits
  • Site Management Organizations (SMO) Audits
  • Safety Reporting Audits

Computerized System Validation Audits

  • Data Management Systems and Electronic Data Capture (EDC)
  • Safety Databases
  • IVRS/IWRS/IXRS
  • Electronic Patient Reported Outcomes (ePRO) Tools
  • Laboratory Information Management Systems (LIMS)
  • Other Applications

cGMP Audits

  • QC Laboratory Audits
  • Investigational Product Packaging and Labeling Facility Audits
  • Depot / Distribution Audits

Standard Operating Procedures

  • SOP Gap Analysis
  • SOP Review and Revision
  • SOP Preparation

Training

  • GCP Training
  • GLP Training
  • 21 CFR Part 11 Training
  • SOP Training
  • QA Training

Consulting

  • Audit Plan Development
  • Audit Follow-Up and Review of Corrective Actions
  • Preparation for FDA Inspections and Mock FDA Inspections
  • Clinical Outcomes Assessment (COA) Consulting, including Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinRO), and Observer Reported Outcomes (ObsROs)

QC2 audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your projects, including audit plan consulting and development, audit scheduling, conduct, and reporting, and audit follow-up services (e.g., review of audit responses).  We conduct both general qualification audits and in-study audits.