Astrum

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Real-World Evidence (RWE),
Late-Phase & HEOR Services

Real-World Evidence (RWE)

From Approval to Real-World Impact: Generating Evidence That Truly Matters

Across Europe, there is a growing recognition that real-world data and real-world evidence strengthen benefit–risk understanding and help ensure that therapies deliver value long after approval. Once a product enters routine clinical practice, sponsors must demonstrate sustained safety, effectiveness and patient-centred outcomes — not only to regulators, but to clinicians, payers and health systems.

At Astrum, we design and deliver late-phase and real-world evidence programmes that bridge this gap. Our integrated approach — spanning primary data research, secondary analytics and hybrid, multi-source evidence — provides the decision-grade insights needed to support access, optimise value communication and understand how treatments perform in real life.
Below is our full RWE, HEOR and evidence ecosystem.

Astrum RWE & Evidence Services

Secondary Data Research

Primary Data Research

  • Astrum designs and delivers high-quality non-interventional studies that generate real-world evidence directly from routine clinical practice.
  • Our siteless, digital PRO solutions capture the patient voice at scale and in real time.
  • PASS and PAES programmes are executed in full alignment with ENCePP guidance and GVP Module VIII, providing regulatory-grade safety and benefit–risk insights.

Registries & Patient Insights

  • We build robust disease and product registries with seamless interoperability to EHRs and patient-facing digital tools, supporting long-term follow-up in real-world settings.
  • Our qualitative research explores lived experiences, motivations and barriers across the patient journey.
  • Ecological studies provide rapid, cost-efficient insights when patient-level data is unavailable or restricted.

Secondary Data RWE & Analytics

  • Astrum analyses real-world data from EHRs, claims, registries and federated data networks to answer clinical, safety and market access questions.
  • Our Delphi panels and structured consensus approaches align experts on pathways, standards and outcomes where empirical evidence is limited.
  • Advanced NLP capabilities unlock unstructured clinical text to identify cohorts and generate evidence at scale.

Evidence Synthesis

  • We conduct gold-standard systematic literature reviews and meta-analyses to build transparent and defensible evidence foundations for clinical, regulatory and HEOR decision-making.
  • Data validation studies assess the completeness, integrity and accuracy of secondary data sources, ensuring methodological robustness.
  • Outputs support HTA submissions, payer dossiers, publications and portfolio strategy.

HEOR & Market Access Evidence

  • Astrum develops economic models grounded in real-world practice, integrating clinical trial data, RWE and patient-reported outcomes.
  • Our cost-effectiveness, cost-utility and budget impact analyses guide pricing, reimbursement and payer negotiations.
  • We support national and regional HTA requirements with clear, value-based evidence.

Hybrid & Multi-Source Evidence

  • We integrate clinical trial data, real-world evidence, PROs and HEOR into unified evidence packages that support development, access and commercialisation strategies.
  • Risk minimisation effectiveness studies evaluate how RMMs perform in everyday clinical practice, supported by chart reviews, surveys and RWD analytics.
  • This holistic approach strengthens benefit–risk understanding and supports ongoing dialogue with regulators.
Speak with our RWE team

Why Astrum​

  • Strong European presence – Reliable experience running late-phase and real-world studies across several European countries.
  • Practical, integrated data solutions – Simple and effective tools for remote data collection, RWE projects and patient-reported outcomes.
  • Solid methodological know-how – Experienced team in observational study design, evidence reviews and health-economic evaluations.
  • Flexible ways of working – We can manage full programmes or support only the parts you need, such as data management, monitoring or safety reporting.

Astrum offers the people, tools and processes needed to generate trustworthy late-phase and real-world evidence-helping treatments show their value in everyday practice.