We work to the standards our sponsors expect from us – and audit us against.
3P Consulting GmbH works with a documented quality-management framework tailored to non-interventional studies, registries, post-authorisation research and scientific real-world evidence projects. Project-specific SOPs, templates, training records and quality documents can be provided as required.
For non-interventional studies, registries and observational research, relevant GCP principles are applied in a risk-based and project-appropriate manner, taking into account the applicable regulatory framework, sponsor requirements and the observational nature of the study.
Safety processes are defined project-specifically and may include SAE/ADR/ICSR workflows, reconciliation procedures, sponsor safety-database interfaces and safety reporting support. SUSAR-related processes are addressed where applicable to the study type and regulatory framework.
Projects are designed with EU-GDPR-compliant data-protection concepts, role-based access, pseudonymised study data where applicable and documented data flows between sites, service providers and sponsors.
Vendor-qualification documentation, quality overviews, data-protection information and project-specific evidence packages can be provided on request and adapted to the sponsor’s qualification process.
Sponsor-facing quality documentation can be prepared and maintained in line with project requirements, qualification questionnaires and audit requests.