Quality and compliance
We operate a documented quality management system and our own quality function, and we state where we are rather than where we would like to be.
Standards
- ICH-GCP E6
- Declaration of Helsinki
- ISO 14155 for device investigations
- EMA bioequivalence guideline
- National regulations in each country
Systems and oversight
- Full SOP set approved, trained and in use
- In-house Quality Assurance Manager
- Chronicles for CTMS, EDC and eTMF
- Risk-based monitoring and co-monitoring
- Internal audits and CAPA management
Data protection
- UK and EU GDPR compliant
- Microsoft 365, data resident in Germany
- Controlled access and validated systems
- Pseudonymisation at source
- Documented transfer arrangements
How our quality system is tested
Our quality system has been tested the practical way — by vendor qualification and audit from the global and mid-size CROs we work for, each of which assessed us before contracting, and by sponsor oversight across 78 studies. We are members of EUCROF and the BioIndustry Association. Full QMS documentation is available for review in advance of any contract.