Services
Services
End-to-end execution of your real-world evidence study. 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
- Curated site networks in DE/AT and Wave-1 countries.
Execution
- EDC & data management
- Validated platforms, edit checks, source data verification.
- Site identification & onboarding
- Joint work with MSL teams, contracting and remuneration.
- Monitoring
- Risk-based, remote and on-site, GCP-aligned.
- Pharmacovigilance
- Case processing, SUSAR reporting, sponsor safety-DB interfaces.
- 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, EU-CTR, local specifics.
- Data protection / GDPR
- DPIAs, processor agreements, pseudonymisation.
- Quality management
- SOP framework, CAPA, audit preparation.
- Vendor qualification
- Qualification questionnaires, audit support, sub-contracting.