Global Quality Audits

• GCP Site: audits of clinical investigator sites for compliance with the clinical protocol, ICH GCPs, and applicable country regulations
• Vendor: qualification/requalification of CROs, DM providers, Central Labs, Specialty Labs, Computer System providers
• Internal: audits of internal processes and controls to establish compliance and find process improvement opportunities
• Trial Master File: audits of electronic and paper-based TMFs to ensure on-going inspection readiness
• Document Audits: audits of protocols, amendments, and clinical study reports
• Affiliate/Local Operating Company Audits: internal audits of global affiliate (local operating company) offices.
• Program Audit Plans: comprehensive audit plans for clinical programs and use of data mining for site audit selection
• Audit Trending: trending, analysis, and process improvement recommendations of audit data

Inspection Preparation

• Inspection Readiness Plans: Sponsor and site plans
• Inspection training/Mock Inspections: interview training, inspection process training and mock inspections
• Investigator Site Preparation and support: site training, preparation, and on-site support for international audits
• Sponsor Inspection Management and Support: back room support and management for Regulatory Inspections

Quality Systems

• Gap Assessments: Quality Management gap assessments
• Controlled Document Authoring: SOPs, Working Practices, Quality Manuals
• Training Program Implementation: design and implementation of training programs tailored to company needs
• Audit Program Implementation: establishment of internal and external audit programs
• Quality Metrics: establishment and tracking of Quality Metrics

Investigations

• Investigations: into non- compliance, scientific misconduct, and fraud
• Compliance plans: thorough CAPA plans and investigation reports

Remote QA

• QA support: for companies with limited or no QA resources
• GCP Resource: on-call GCP resource
• Study Team Support: QA support for all phases of studies
• Audit Program Management: establishment of internal and external audit programs

Vendor Management

• Vendor qualification: due diligence audits to determine vendor suitability to perform contracted work
• Vendor Management: plans for oversight and tracking of vendor quality and performance
• Vendor Metrics: tracking vendor performance with established metrics