Clinical Operations
We offer 9+ years of experience in clinical operations working through all levels from CRA to head of department in CROs, big Pharma, small Start Ups, and in Biotech companies. During this time we could gather experience with studies in national and/or international setups, all clinical phases, pharmaceuticals, biosimilars, medical devices, and in various indications, respectively.
We provide excellent operational services within clinical project management including vendor selection and contracting (based on long-term relationships) or help with subtasks such as monitoring, submission to authorities, and maintenance of the trial file.
We also offer services for general clinical operations department tasks such as SOP writing, quality control systems, training of the clinical team, training documentation, development of study forms, documents, and manuals.
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