Keyrus Biopharma is a European full-service Contract research organization (CRO) providing pharmaceutical, biotechnology, nutrition and medical device companies with a broad range of clinical research services from early- to late-stage clinical development , including project management, clinical monitoring, scientific and medical support, investigator and patient recruitment, site management, biostatistics, data management, drug safety, quality assurance, regulatory affairs, and medical writing . Our Services:

• Clinical operations : project management, feasibilitity&patient recruitment plans, monitoring, project logistic, regulatory submissions,…
• Clinical Data Management and biostatistics, Statistical Methodology expertise
• Medical Writing: Clinical Documents, Survey and Observational Reports, Scientific papers and publications, Communications (newsletter, abstract, poster),…
• Pharmacovigilance: Case management, Medical Review,, Writing narratives, PSURs ,…
• Bioinformatics: Development of tools to simplify the treatment and analysis of clinical trial data
• Regulatory affairs: Strategy (planning, consultancy, gap analysis,…), Documentation and submissions (dossier review and compilation, IMPD, IB, Module 2 eCTD, Expert report, ,…), Interaction with agencies,…