Our competences
From the right study design to operational delivery — real-world evidence from a single source.
We select the study design and data source consistently along your research question. We combine methodological rigour with our expertise in HTA procedures and patient access, so that results both withstand scientific scrutiny and are usable in regulatory and communication contexts.
Study types & designs
Observational studies on effectiveness, safety, real-world care and quality of life under everyday conditions, including patient-reported outcomes.
Studies within statutory market surveillance: post-market clinical follow-up (PMCF) for medical devices and post-authorisation safety studies (PASS) for pharmaceuticals, for the ongoing confirmation of safety and performance in everyday care.
Retrospective collection from patient records in hospitals and practices to reconstruct treatment pathways, complication rates and resource use.
Discrete choice experiments (DCE) and Analytic Hierarchy Process (AHP) to measure patient and physician preferences for benefit assessments, product positioning and dossiers.
Structured expert surveys to validate clinical assumptions, treatment pathways or model parameters.
Analyses based on German statutory health insurance (SHI) routine data on care pathways, costs, utilisation and treatment outcomes in real-world care. Depending on the research question, we establish data access via individual health insurance funds, billing centres or the Health Data Research Centre (FDZ). From more than 30 projects with SHI routine data we know the strengths and limits of each source — and choose accordingly.
Preparation of scientific publications and congress contributions as well as advice on communicating results in a recipient-oriented way to payers, clinicians and sales. We accelerate drafts with AI — reviewed and accounted for by experienced medical writers.
Delivery
We deliver the full operational scope of an NIS/RWE study, but as a modern, lean CRO: experienced senior minds plus the purposeful use of artificial intelligence. This way, you benefit equally from speed and experience.
Observational plan, statistical analysis plan (SAP) and study protocol. We define endpoints from the outset with a view to later benefit assessment and reimbursement — an advantage from our market access and HEOR work. AI-assisted templates shorten the preparation of protocol and SAP; methodological responsibility remains with senior consultants.
Notification of the NIS to BfArM or PEI, applications to ethics committees. Standard documents (patient information, informed consent, GDPR data protection concept, contracts with healthcare professionals) are prepared quickly and reliably thanks to our experience.
Set-up and programming of electronic case report forms (eCRFs) including PRO integration, also app-based. We largely automate plausibility and edit checks as well as query logic — less manual cleaning, cleaner data earlier, validated database lock with audit trail.
We base site selection on our experience with SHI routine and care data: we know where patient potential and documentation quality actually come together, instead of selecting by gut feeling.
Initiation and training of participating physicians and study teams, investigator meetings, ongoing site support across the entire recruitment and observation phase. Digital training and communication formats keep the effort for sites low.
Risk-based on-site and remote monitoring with central statistical surveillance (key risk indicators, anomaly analyses): we direct on-site visits to where they are needed, reducing travel costs and lead time. Including consent checks, source data verification, monitoring plan and visit reports.
Central study management with near real-time sponsor reporting: recruitment status, data quality KPIs and timelines available via dashboards at any time instead of only in the monthly report. Assessment and timely reporting of adverse events (AEs/SAEs) to sponsor and authorities.