Services
Services
End-to-end support for real-world evidence, non-interventional studies, registries and post-authorisation research. Modular or full-service.
Study design
- Synopsis & protocol writing
- Senior-clinician-led, methodically rigorous, regulatory-aware.
- Endpoint & PRO strategy
- Validated instruments, patient-reported outcomes, subgroup logic.
- Statistical Analysis Plan
- Pre-specification of primary, sensitivity and subgroup analyses.
- Feasibility & site survey
- Feasibility concepts and structured site surveys in Germany, Austria and selected European countries.
Execution
- EDC & data management
- EDC concepts, validated platform environments where applicable, edit checks, query workflows and data-cleaning coordination.
- Site identification & onboarding
- Joint work with MSL teams, contracting and remuneration.
- Monitoring
- Risk-based remote and on-site oversight tailored to the study type, documentation requirements and sponsor expectations.
- Pharmacovigilance
- SAE/ADR/ICSR workflows, reconciliation procedures, sponsor safety-database interfaces and safety reporting support; SUSAR-related processes where applicable.
- Project management
- Single point of contact, sponsor reviews, steering-committee service.
Analysis & science
- Biostatistics
- Survival models, mixed models, propensity-score methods.
- Epidemiology
- Incidence/prevalence, health-services research, outcomes research.
- Medical writing
- Study reports, manuscripts, congress abstracts, lay summaries.
- Publication planning
- Strategic support from submission to peer-review response.
Regulatory & quality
- Regulatory submission
- Ethics committees, authorities and local notification or submission requirements; EU-CTR-related processes where applicable.
- Data protection / GDPR
- DPIAs, processor agreements, pseudonymisation.
- Quality management
- Documented SOP framework, training records, CAPA concepts and audit-preparation support.
- Vendor qualification
- Vendor-qualification questionnaires, sponsor documentation, audit support and project-specific subcontracting structures.