Our advisory practice offers business insights, advice and recommendations on the suitability, design and business impact of managed access programs for your drug and situation pre- and post-approval.
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
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.
RareiTi™ needs to collect and process personal information in order to deliver services that provide medicines and support under regulated activities. We run joint programmes with our patient’s referring physician/centres and the pharmaceutical manufacturers as part of our pharmacovigilance and drug safety obligations. We also participate in highly regulated activities that require the sharing of your data for clinical evidence purposes outside of a clinical trial.
We are committed to being transparent with you about our use of your personal information. We will always keep your data safe and secure and only use it for the purposes it was obtained. We will ensure we record the lawful grounds for the use of your data and keep you informed of any changes.
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