qc2 provides the following services:
GCP, GLP, and BioAnalytical Audits
• Investigative Sites (In-Study or Pre-FDA Inspection)
• Phase I Units and PK/PD Studies
• Institutional Review Boards
• Clinical Trial Files - Essential Documents
• Clinical Trial Data Listings
• Clinical Trial Reports, ISSs, and ISEs
• Toxicology Laboratories and Studies
• BioAnalytical Laboratories, Method Validation, and Assays
Sponsor, CRO, and Vendor Audits (Qualification or In-Study)
• Computer System Validation and 21 CFR Part 11 Compliance
• Electronic Data Capture
• Data Management Systems and Biostatistics
• Clinical Operations and Project Management Systems
• Medical Writing
• Regulatory Affairs
• Safety Systems and Medical Monitoring
• Interactive Voice Response Systems
• Central Reading Facilities (ECG, Radiology, etc.)
• Clinical Pathology Laboratories and Esoteric Testing
• Investigational Product Packaging, Labeling, and Distribution
• Due Diligence Audits
Standard Operating Procedures
• Gap Analysis of Existing SOPs
• Revision of Existing SOPs
• Preparation of New SOPS
Training and Customized Workshops
• GCPs and GLPs
• Standard Operating Procedures
• Quality Assurance
Consulting
• Audit Plan Development
• Audit Follow-Up and Review of Corrective Actions
• Preparation for FDA Inspections, and Mock FDA Audits
List of Services
