Focus on Accelerating Rare Disease Therapies
Though each disease or condition is rare, their combined impact worldwide is not, affecting nearly 400 million people globally. Everyone deserves equitable access to healthcare, but those suffering from a rare disease are more likely to face misdiagnosis, treatment inequality, and isolation. As we prepare to recognize Rare Disease Day , advancing therapies for rare diseases remains central to our mission. Learn More >
Conference Presentation: Decentralized Solutions for Complex Clinical Trials
In this presentation, Shaheen Limbada, Veristat EVP of Innovation and Strategy, shares Veristat’s streamlined DCT deployment model which significantly eases the burden on patients and sites and reviews the lessons learned from a natural history study that pivoted to virtual patient visits mid-study.?
Podcast: Considerations for Developing Rare Disease Treatments?
When developing a new therapy for a rare disease, a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities. Listen to our podcast as Veristat experts share important considerations to reduce your regulatory risk along the way.?
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Case Study: Approvals for Ultra-Rare Hematologic Malignancy
Using the results of a single-arm Phase I/II study, Veristat and the sponsor company collaborated to present a strategy for demonstrating the benefits and risks of the targeted therapy in this patient population to regulatory authorities. The sponsor engaged our team for strategic consulting, statistical and programmatic support, and medical writing to plan and execute the marketing application process, eventually leading to both FDA and EMA approval.
Solution: Natural History Trials for Rare Diseases
Developing a therapy for a rare or ultra-rare disease is life changing work with unique challenge. The use of natural history (or non-interventional) data can help to inform the clinical development process. At Veristat, we have completed many full-service natural history studies. Our global team leverages lessons learned from the course of our work conducting 30+ Natural History and Observational trials.
Dates for your calendar!
28 Feb 2023 -?Executive Roundtable Meeting - Decentralized Trial Solutions for Complex Clinical Trials?|?Boston, MA -?Learn more ?
12-14 Mar 2023 - ACDM Annual Conference 2023?-?Learn more ?