Big data will never be an option for rare disease research. By definition, rare diseases affect around 620 people per million. Ultra-rare diseases may affect as few as 1 in a million. When you have a tiny population, scattered across the globe, how can you hope to find enough clinical trial participants to demonstrate efficacy…Read More
Our advisory practice offers business advice and recommendations on the suitability, design and business impact of Managed Access programs for patients with rare diseases.
We deliver customized global Managed Access Programs designed to meet complex challenges for patients with a rare disease at the point of care.
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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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