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
