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Insight

Retrospective multicenter study for reimbursement

Country-specific real-world evidence to support payer dialogue and reimbursement dossiers, with results in months rather than years.

Real-World Evidence
Key takeaways
  • Non-interventional study on routinely collected data from expert centers — one lighter, faster ethics submission.
  • Timelines are aligned to dossier submission dates.
  • Participating clinicians are engaged as investigators and co-authors.

The set-up

A non-interventional study built on routinely collected data from expert centers. Research from day one, with protocol and ethics approval up front, but a lighter and faster submission than an interventional trial.

The study characterizes treatment patterns, disease burden and the care pathway, including diagnostic and referral delays, and identifies the subpopulations most likely to benefit.

What the sponsor gets

Country-specific real-world evidence for payer dialogue and reimbursement dossiers, health-economic inputs such as cost-of-illness for HTA negotiations, and a publication pipeline with participating clinicians as co-authors.

What every project includes

An ePRO patient app, a sponsor dashboard covering per-site inclusions and adherence with CRM integration, eConsent, the Trusted Third Party privacy framework, hospital EHR integration, and KOL steering with a publication pipeline.

What is collected

From the patient and prescriber: validated PROMs and quality-of-life scores, daily symptoms and side effects, medication intake and adherence, prescription and usage data, and wearable or sensor data.

From the hospital record: demographics and comorbidities, biomarkers and blood tests, clinical scores, treatment history and real-world effectiveness.

Common questions

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