Our advisory and consulting practice offers business insights, advice and recommendations on the suitability, design and business impact of managed access, expanded access, compassionate use, and named patient programs for your drug and situation pre- and post-approval and as part of a comprehensive market access strategy.

Consultancy and advisory services

We help achieve your business objectives with our deep knowledge of the complex rare disease environment, global regulatory requirements, patient advocacy connections and managed access ecosystem experience.


  • Gap analyses
  • Market assessments
  • Care / compliance modeling
  • Community influencer research
  • Patient experience mapping
  • Caregiver / payor needs assessments


  • Access / supply challenges
  • Disease / treatment-specific care requirements
  • Regulatory hurdles
  • Payer dynamics
  • Clinical / community KOLs


  • Customized access and medicines management plans
  • Home care, monitoring and reporting / data strategies
  • Advocacy engagement plans
  • Reimbursement / coverage plans


  • Leveraging a full suite of RareiTi CARE services, advisors and partners around the world
  • Leveraging RareiTi DATA to gather and track meaningful data and evidence of outcomes

COVID-19 Response

The COVID-19 pandemic is having significant impact on clinical trials globally. Many trials face suspension or closure due to clinical priorities and the impact of social distancing and quarantine.

Clinical trial patients with a rare condition face great challenges; being part of a clinical trial when living with a rare condition can often be the only lifeline available, offering the chance to access novel therapies that could improve life enormously. During the pandemic, not being able to access novel therapies could have a major negative impact on health, disease progression and mortality. In addition, progress toward an approved therapy should not have to be completely stalled because of a lack of ability to collect relevant data.

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