Quality & compliance

Quality & compliance

We work to the standards our sponsors expect from us – and audit us against.

ICH-GCP E6(R3)

Full application of Good Clinical Practice in NIS and registry settings, where applicable.

GVP / pharmacovigilance

Good Pharmacovigilance Practices modules, trained case-processing functions.

EU-GDPR / BDSG

DPIAs, processor agreements, documented pseudonymisation.

ISO-aligned QMS

SOP hierarchy, training and change-control system, annual management reviews.

Sponsor audits

Audit-ready to sponsor specifications. Full qualification documentation on request.

Vendor qualification

Full qualification dossiers provided within 5 working days.