The Pre-IND to Market Approval Roadmap in the U.S.
Understanding the clinical, preclinical, and technical development requirements is crucial when designing an early development pathway.
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know
Given that the regulation is likely to change considerably, drug developers may need to revisit their development strategy. In the meantime, building a strategy around these evergreen(...)
2022 Recap: Your Favorite Alira Health Publications
In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)
Webinar Replay: Partnering with Patients to Streamline Trial Operations: Protocol to Regulatory Submission in 60 days
Learn how patients and patient advocacy organizations can be directly enabled as powerful partners to facilitate all stages of DCT deployment, from protocol design, recruitment, engagement(...)
External Control Arms: The Way to Go?
The growing implementation of Single Arm Trials (SATs) with External Control Arms (ECAs) has been the subject of heated debate across Europe.
Debate Sobre los IPT en Oncología
We are pleased to announce our next event, “Debate Sobre los IPT en Oncología,” focusing on price and reimbursement (P&R) of vital oncology and oncohematology therapies.
The MedTech Conference 2022
We are pleased to share that we will be joining the MedTech Conference 2022 as sponsors and speakers! This year’s edition will have more than 100 sessions focusing on today’s hot topics.