Clinical Trial Management
Contract Development and Manufacturing
Decentralized Clinical Trials
European Medicines Agency
Hybrid Clinical Trials
In-Vitro Diagnostic Regulation
Outsourcing Clinical Trials
Rare Disease Trials
Research & Development
Research and Development
Alira Health enhances its market access services through a strategic partnership with Centivis
Alira Health, a global healthcare advisory and technology company, announced a strategic partnership with Centivis AG, a boutique market access consulting agency, specializing in digital(...)
Alira Health Strengthens Clinical Operations with the Acquisition of Sourcia
We acquired a full-service Contract Research Organization (CRO), Sourcia, that provides services for Phase I to Phase IV clinical trials with a focus on biotech, medical devices, and(...)
We Secured Breakthrough Device Designation from FDA on PEDRA Xauron Perfusion System
We are proud to announce the firm’s Regulatory practice has secured a Breakthrough Device Designation from FDA for the real-time tissue perfusion system, PEDRA Xauron Perfusion System.
Alira Health Adds CMC Services through Acquisition of Chamow & Associates
We have acquired Chamow & Associates (www.chamowassociates.com), a California-based integrated CMC advisory firm. This acquisition brings expertise in biologics manufacturing, quality(...)
Alira Health’s Ventures Portfolio Company, X-COR Therapeutics, Closes Initial $2.6M Funding Round
Alira Health congratulates X-COR Therapeutics for closing a $2.6M seed financing to continue developing its novel extracorporeal carbon dioxide removal device toward clinical trials.(...)
CMS Issues Proposed Rule to Cover ‘Breakthrough’ Medical Devices
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule this week that would give breakthrough medical devices national Medicare coverage on the same day they receive(...)
We Announce our Role as Regulatory Advisor to Liberate Medical on their Emergency Use Authorization of VentFree™
We have supported Liberate Medical, a clinical/commercial-stage medical device company, in their Emergency Use Authorization from the Federal Drug Administration (FDA) for the VentFree™(...)
Alira Health Welcomes Marie-Aude Ohresser, Vice President, Regulatory Affairs
BOSTON, USA – Alira Health (www.alirahealth.com), a leading international healthcare and life sciences advisory firm, announces the appointment of Marie-Aude Ohresser to Vice President,(...)
Latest from Alira Health
Spain Healthcare Innovation Summit 2022
We are pleased to join the Spain Healthcare Innovation Summit as sponsors and speakers. Join our speaker Manuel Vázquez Roso, Director Market Access, for the panel “El Rol de la(...)
PHUSE EU 2022
We are pleased to announce that we will be joining as sponsors and delegates PHUSE EU, an event that brings together the PHUSE global community to collaborate on hot topics guiding(...)
ISPOR EU 2022
We are excited to announce that we will be joining ISPOR EU 2022, the leading global conference for Health Economics and Outcomes Research.
Webinar: Health Economic and Outcome Research (HEOR) for Medical Technologies for the US Healthcare Systems
A well-designed Health Economics and Outcomes Research (HEOR) study is vital for generating short- and long-term effectiveness data. Attend the webinar to gain a stepwise strategic(...)
RARECast: Leveraging Technology to Empower Patients and Decentralize Clinical Trials
Technology plays a central role in the future of patient empowerment and decentralized clinical trials. Listen to the podcast to learn more.
Exclusive MedTech Webinar Series “Expanding Beyond APAC”
Join this series of webinars to learn about the strategies, challenges, and best practices of scaling beyond the Asia Pacific MedTech market.
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.
The Economics of Survival
Healthcare decision makers are already grappling with increased demand for healthcare, and highly constrained budgets. However, unless we act immediately the climate emergency will(...)
How to Choose the Right Analytical Methods
In this article, we focus on the analytical method development around your biologics. Analytical method development is an important component of biologics development and the control(...)