Quality and Compliance
Documented quality management system aligned to GCP and inspection readiness expectations.
Due diligence ready
Qualification package available upon request, sample deliverables, QMS overview, insurance attestation, escalation framework summary.
QMS overview
- SOP based operational governance
- Document control
- Training and role qualification
- Deviations, issues, CAPA
- Vendor governance
GCP alignment
Aligned with ICH GCP principles and sponsor requirements, implemented through controlled procedures and documented oversight.
Inspection readiness support
- Readiness checklists
- Audit support collaboration
- TMF inspection readiness guidance
Controlled document catalog summary
Document types are listed publicly. Documents are provided upon request during sponsor qualification.
- Medical review and safety governance SOPs
- Study oversight and escalation SOPs
- Vendor governance SOPs
- Issue management and CAPA SOPs
- Document control procedures
- Training and qualification records process
Documentation available upon request during sponsor qualification.
Professional standards and insurance attestation
Professional liability and errors and omissions coverage maintained. Certificates available upon request during contracting.
Due diligence
Qualification package available on request, sample deliverables available, insurance attestation available, QMS overview available, escalation framework summary available.