Services

Investigator Site Audits

• Routine Investigator Site Audits (Phase I to IV)
• Targeted Investigator Site Audits (Phase I to IV)
• For cause Investigator Site Audits (Phase I to IV)

System Audits

• System audits of sponsor/CRO/Phase I

Mock inspections

• Inspection preparation and training (investigator site/CRO/sponsor)
• Mock inspections
• Inspection facilitation

Vendor system audits

• Interactive Response Technology (IRT)
• Central ECG reading SP
• Call centres
• Data Management
• Database
• Biostatistics
• Regulatory
• Trial Master File (TMF)
• Clinical Trial Supply (CTS) compliance with Good Distribution Practice (GDP)
• Translation Services
• Clinical Manufacturing Organization (CMO) compliance with Good Manufacturing Practice for Investigational Medicinal Product (GMP for IMP)
• Archives

Document Audits

• Study Protocols
• Case Report Forms (CRFs)
• Informed Consent Forms (ICFs)/Patient Information Sheets (PISs)
• Investigator Brochures (IBs)
• Clinical Study Reports (CSRs)
• Summary of Clinical Efficacy (SCE)
• Summary of Clinical Safety (SCS)

Quality Management System (QMS)

• Review of existing QMS
• Gap analysis
• Developing a new QMS (writing company policies, standard operating procedures, work instructions, etc.)
• Corrective and Preventative Action Plan (CAPA)/Effectiveness Check (EC) review

PV system and process audits (Pre & Post marketing audits)

• Pharmacovigilance System Master File (PSMF)
• Qualified Person for PV (QPPV)/Local Responsible Person
• Global Safety Database
• Case Management (SUSAR/ICSR)
• Aggregate Reporting (PSUR/DSUR)
• Risk management
• Signal management
• Medical coding
• Product labelling
• Regulatory Intelligence
• Post authorisation safety studies (PASS)
• Patient Support Program/Non-Interventional Program
• Quality management system
• Vendor management and Marketing Authorisation Holder (MAH) oversight
• Audit strategy planning and management

Third party audits

• Commercial partners
  • Marketing partners
  • Distributors
  • Licence partners
• Service providers/vendors
  • PV
  • Medical Information
  • Call Centres
  • Market Research Programs
  • Patient Support Programs
  • Pregnancy Prevention Programs
  • Compassionate Use Programs

Consultancy

• Risk based audit planning
• Audit program management
• Inspection Readiness training
• Mock inspection
• GAP analysis
• CAPA/EC management

Non-clinical laboratory audit of animal or non-animal facilities

• Facility audits
• Study audits
• Critical or in-process phase inspections
• Protocol audits
• Data audits
• Report audits
• Procedure/process audits
• Bioanalytical laboratory audits
• Mock inspections
• Document reviews
• Archive audits
• Qualification or requalification audits
• Subcontractor and vendor audits
• GLP GAP analysis

Audits of clinical and bioanalytical laboratories that process human samples for safety, biomarkers, other speciality analysis, etc.

• Facility audits
• Study audits
• Protocol audits
• Data audits
• Report audits
• Procedure/process audits
• Mock inspections
• Document reviews
• Archive audits
• Qualification or requalification audits
• Subcontractor and vendor audits
• GCLP GAP analysis

Computer system validation audit

• System specific computer system validation audits
  • Data centres
  • Back and data recovery
  • Business Continuity and disaster recovery
  • IT security
• 21 CFR compliance GAP analysis
• Computerised System Development Life Cycle (SDLC) process audits
• All aspects of system and application planning and development processes and change control
• CSC GAP analysis

• Investigator Site Assessment
• Vendor assessments
• Mock inspections
• SOP development
• QMS consultancy