Clinical and Medical Affairs
Real-world evidence.
Strategic generation of real-world evidence (RWE) and real-world data (RWD). We design methodologically sound observational and registry studies for HTA submissions, label extensions, and post-market requirements.
Is RCT data alone still sufficient for payers?
Randomized controlled trials (RCTs) demonstrate efficacy, but HTA agencies are increasingly demanding evidence of effectiveness in real-world clinical practice. The lack of valid real-world evidence (RWE) designs is currently systematically hindering reimbursement success:
- The evidence gap in HTA. How do you bridge the gap between highly selected RCT populations and the more complex, multimorbid patients encountered in real-world clinical practice for G-BA and NICE?
- Post-market signals. How do you establish an early warning system that identifies unforeseen post-market safety signals in a timely manner before regulators enforce label restrictions?
- Label extensions without Phase 3 trials. When and how can high-quality real-world data (RWD) be used to obtain label extensions for rare subpopulations without conducting expensive new Phase 3 trials?
From a pragmatic registry strategy to publication: We implement methodologically sound RWE designs that are not dismissed as “low-quality evidence.”
Our RWE Services.
We combine rigorous epidemiological analysis with strategic market access to generate data that is truly accepted by regulatory authorities, health insurers, and physicians.
Pharmaceuticals: Registry and Observational Studies
End-to-end design of disease registries, non-interventional studies (NIS), and pragmatic clinical trials (PCTs) to collect robust long-term data on efficacy and safety.
MedTech & IVD: PMCF & PMPF under the MDR/IVDR
Strategic planning and implementation of Post-Market Clinical Follow-Up (PMCF) for medical devices and Post-Market Performance Follow-Up (PMPF) for in vitro diagnostic devices to ensure CE certification.
HTA-compatible data strategy
Ensuring that RWE endpoints are precisely aligned with the requirements of HTA authorities (G-BA post-marketing data collection, NICE RWE Framework) in order to minimize reimbursement discounts.
Claims Data & Retrospective Analyses
Analysis of secondary data sources such as electronic health records (EHR) and claims data to support treatment pathways, the burden of illness, and outcomes-based agreements.
Frequently Asked Questions About Real-World Evidence.
Does the G-BA accept real-world evidence?
Yes, but under very strict methodological requirements. Particularly in the case of orphan drugs or Advanced Therapy Medicinal Products (ATMPs), the G-BA is increasingly requiring post-marketing data collection to systematically address initial gaps in the evidence from clinical trials. Real-world evidence must meet the highest quality standards in this context.
What is the difference between RWD and RWE?
Real-world data (RWD) refers to raw data from everyday clinical practice (e.g., patient records, billing data, wearables). Real-world evidence (RWE) is the clinical evidence derived from a structured, methodological analysis of this raw data. RWD only becomes usable RWE through the right study design.
Can RWE data completely replace an RCT?
Generally, this does not apply to the initial approval of blockbuster drugs. However, for label extensions in rare indications or as synthetic control arms in single-arm studies, RWE data is increasingly being accepted by the FDA and EMA as a primary source of evidence.
At what point should RWE be integrated into the strategy?
Ideally, this should be done in Phase 2. If you don’t realize until after the launch that registry data for the HTA extension is missing, you’ll lose critical months. A proactive RWE strategy starts early and uses initial observational cohorts as early as Phase 3 to demonstrate the “burden of disease” to payers.
Additional market access expertise.
Fill in the gaps in your evidence.
Please describe your current RCT situation to us. We’ll assess, with no obligation, which RWE design will most effectively convince payers and regulators.