Industries We Support
Industries We Support
Rewoso for
Pharmaceutical
and Biotech
Industry
We are your partner for real-world evidence insights.
At Rewoso, we specialize in helping pharmaceutical companies make evidence-backed decisions with confidence. Our interdisciplinary team delivers precise, actionable real-world data insights for every stage of a drug’s lifecycle—from early development through to post-marketing. Major pharmaceutical industries have profited from us in these areas:
- Real-world evidence generation in many indications
- Claims-data based analyses
- Registry-data based analyses
- International real-world evidence analytics
- Access to multiple real-world data sources
Example project – late-stage drug trial
1-minute read
For drugs in late-stage trials, we have provided multiple external control arms to show the efficacy of a new product, which had been tested in a single-arm Phase III study. The positive results, which go beyond network meta-analysis and are accepted by payers more readily, have helped our clients to argue for the efficacy of their product against a range of real-world competitors rather than only one competitor.
Case Study: External Control Arms for RCTs with RWD
Real-World Evidence to Enhance Clinical Trial Evidence
The Challenge of Comprehensive Treatment Effects. While randomized controlled trials (RCTs) are the gold standard for evaluating treatments, the health authorities increasingly require data that generalizes and captures real-world effectiveness. Particularly, later-phase trials may suffer from a limited number of comparators, sample sizes, and short follow-up periods. To overcome these issues, external control arms offer a robust and reliable treatment effect evaluation, surpassing the limitations of traditional RCTs and without the untestable assumptions of network meta-analyses.
The Approach to Broaden Treatment Effects. To empirically address critiques about RCTs, we use real-world data (RWE) to generate quantitative effects of the treatments across multiple comparators, in larger samples in actual clinical practice. How? Keeping the RCT as the gold standard we carefully select a suitable control group for the RCT from a large real-world database, aligning the RW population to the RCT population, thoroughly validating the approach, and deploying advanced methods like propensity matching, weighting, and target-trial emulation. Through this, we can provide additional comparator arms for RCTs from RWD while minimizing selection bias and controlling.
Results. This approach (published in Muros et al, 2020) resulted in a propensity-matched analysis to evaluate the efficacy of Ocrelizumab against five other comparators that were not part of the original RCT in treating relapsing multiple sclerosis. By carefully matching treated patients with untreated controls based on a multitude of factors, we were able to provide a broader impact of the drug, going beyond the treatment effects that were known from clinical trials only.
Benefits
of the Rewoso
approach
GreaterRelevance
Show the effects of treatments across diverse patients and settings by using real-world data.
Accelerated Development
Accelerate drug development timelines by leveraging existing, propensity-matched real-world cohorts.
Factual Decision-Making
Get data-driven information for important decisions and the optimization of treatment strategies.
Cost-Effective Research
Real-world studies often cost less than traditional trials by reusing existing data sources.
Beyond Network Meta-Analyses
External control arms yield individual-level comparisons, with fewer assumptions than meta-analyses.
Greater Relevance
Show the effects of treatments across diverse patients and settings by using real-world data.
Accelerated Development
Accelerate drug development timelines by leveraging existing, propensity-matched real-world cohorts.
Factual Decision-Making
Get data-driven information for important decisions and the optimization of treatment strategies.
Cost-Effective Research
Real-world studies often cost less than traditional trials by reusing existing data sources.
Beyond Network Meta-Analyses
External control arms yield individual-level comparisons, with fewer assumptions than meta-analyses.
Benefits of the Rewoso approach
Greater Relevance
Show the effects of treatments across diverse patients and settings by using real-world data.
Accelerated Development
Accelerate drug development timelines by leveraging existing, propensity-matched real-world cohorts.
Factual Decision-Making
Get data-driven information for important decisions and the optimization of treatment strategies.
Cost-Effective Research
Real-world studies often cost less than traditional trials by reusing existing data sources.
Beyond Network Meta-Analyses
External control arms yield individual-level comparisons, with fewer assumptions than meta-analyses.
Rewoso for
Medical Researchers and Academia
We support your research and registry digitalization.
At Rewoso, we collaborate with academic researchers to close evidence gaps in health sciences. Our team supports scientists throughout the evidence-generation process—from the digitalization of the data collection through complex statistics for high-impact publications. World-leading scientific institutions have partnered with in these areas:
- Digital health data collections
- Mobile applications for patient data collection
- Decision aids for the medical profession
- Highly-complex statistical analyses
- AI and machine learning analyses
- Bias correction in long-term outcome projects
- Multi-country observational projects
- Clinical-to-registry data combination
Example project – academic neurology registry
1-minute read
Collaborating with a German medical registry in neurology that holds complex longitudinal health data spanning over 10 years of observations from over 50’000 patients, we supported their data collection by developing a new digital platform. Our health-data experts have published methodologically complex research jointly with the registry, we generated multi-data-source insights, provided AI-based statistical analyses, and cooperated in real-world evidence research projects that resulted in over 20 publications during the last 7 years.
Benefits
of the Rewoso
approach
Integrated Data
Efficient collection of clinical, socioeconomic, and psychological in routine care.
Publication Support
Cutting-edge manuscript submissions based on the right methods for registry data.
Broad Outreach
Show patient needs and burdens across multiple settings and multiple countries.
Solve Bottlenecks
Solve bottlenecks in statistical capacities and research sponsoring.
Benefits of the Rewoso approach
Integrated Data
Efficient collection of clinical, socioeconomic, and psychological in routine care.
Publication Support
Cutting-edge manuscript submissions based on the right methods for registry data.
Broad Outreach
Show patient needs and burdens across multiple settings and multiple countries.
Solve Bottlenecks
Solve bottlenecks in statistical capacities and research sponsoring.
Rewoso for
Digital Health Technology
We support you from development to market access.
Our team provides digital health companies with the specific evidence-driven information that is required for success across every stage of the development process–from early development to launch and beyond. Digital health technology experts have profited from us regarding the following topics:
- Qualitative research during development
- Validated digital endpoint selection
- Evidence generation for regulatory approvals
- Data-driven support for market entry
- Marketing efforts after market entry → See DiGA manager
- Real-world evidence for pricing negotiations
- Combination of clinical trial and real-world data
- Full digital health app development
Example project - digital mental health treatment
1-minute read
To inform pricing negotiations for a digital mental health application in the German market, we delivered timely and impactful data-driven evidence. Using a data-fusion approach, we combined patient data from a medical registry with application usage data to robustly and broadly demonstrate the efficacy, usage patterns, and user engagement with the digital health app in clinical practice. These new results provided crucial evidence that complemented the company’s Phase III trial results, strengthening their market entry strategy, and supporting their pricing objectives.
Benefits
of the Rewoso
approach
Efficient Development
Accelerate development timelines with data-driven insights exactly when needed.
Rapid Evidence
Argue for the positive effects of digital health technology on the health system.
Broader Relevance
Robust and relevant evidence in representative settings from real-world data.
Marketing Access
Unique marketing through our digital-health comparison platform → See DiGA manager
Benefits of the Rewoso approach
Efficient Development
Accelerate development timelines with data-driven insights exactly when needed.
Rapid Evidence
Argue for the positive effects of digital health technology on the health system.
Broader Relevance
Robust and relevant evidence in representative settings from real-world data.
Marketing Access
Unique marketing through our digital-health comparison platform → See DiGA manager
