High-quality data is the foundation of strong clinical evidence.
All data processes are designed with traceability, integrity and audit requirements in mind.
Statistical Analysis Plan (SAP)
Our biostatisticians provide sample size calculations and analysis strategies to ensure scientifically valid and fully auditable outcomes.
Interim Reporting
For long-term or safety-focused studies, interim analyses are performed to assess study progress and safety profiles.
Final Clinical (Performance) Study Report (CSR/CPSR)
We deliver ISO 14155 / ISO 20916–compliant, audit-ready final reports aligned with Notified Body expectations.
These reports serve as core inputs for the CE Technical Documentation, CER/PER and PMCF/PMPF activities.