Consultancy: General
Consultancy: Elaboration and revision of SOPs
Consultancy: Planning, organisation and training in new SOPs
Consultancy: Preparation and audit attendance
Consultancy: Preparation of responses to audits
Consultancy: Capacity building of research centres
Consultancy: GCP
Quality Control: Update and review of study records
Quality Control: Accompaniment on monitoring visits
Quality Control: Development of protocols, CRFs and informed consent
Quality Control: Data management
Quality Assurance: GCP audits
Quality Assurance: Systems audits
Quality Assurance: Process audits
Quality Assurance: Clinical trial audits
Quality Assurance: Pharmacovigilance audits
Preparation of Inspections: Coordination of preparatory process
Preparation of Inspections: Review of study records
Preparation of Inspections: Preparatory audits at research centre
Preparation of Inspections: Training of research centre team
Preparation of Inspections: Training of monitors and project managers
Preparation of Inspections: Post-inspection follow-up