Alira Health is a healthcare advisory and technology company. The company offers services comprising research and clinical development solutions, technology-based consulting, and real-world evidence (RWE). Its in-house product development lab provides an onsite biosafety level II (BSL-2) facility with a library of clinical bacteria isolates; cell models for inflammation, migration, 3D tumour, and apoptosis; microbiology and biofilm models; expertise in wound healing and infection prevention; fluorescent and colourimetric microplate assays; preclinical animal models; and gene expression (qPCR) and immunocytochemistry. Alira Health’s regulatory pharma services and expertise cover regulatory strategy and due diligence; assistance with accelerated review program; food and drug administration (FDA) application preparation, management, and submission; and FDA meeting preparation and representation. Its clinical trial services consist of study design and protocol writing, investigator training, data management and biostatistics, trial management and clinical operations, site selection and feasibility, and subject recruitment and retention. Chemistry, manufacturing, and controls (CMC) services include manufacturing, quality, regulatory, and project management to integrate CMC packages into positive investigational new drug (IND) and biologics license application (BLA) filings. Alira Health provides a range of services and solutions for RWE such as helping clients with research protocols, data models, management, and technology solutions; clinical solutions for virtual trials and RWE; and digital therapies for prevention and care management.
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