FGK Clinical Research GmbH is a contract research organization (CRO) that provides clinical development and consulting services to pharmaceutical, biotechnology, and medical device companies. The company’s consulting department offers biostatistical support for drug and medical device development, sample size calculations, adaptive designs, and clinical trial modelling. FGK’s representative service facilitates the regulatory submission of clinical trials and represents clients in a range of application processes such as marketing authorization and orphan drug designation. Its Regulatory Affairs department communicates with competent authorities, ethics committees, local authorities, and insurance companies; develops protocols, informed consent forms, drug labeling, and other study documents; submits application dossiers, updated information, expedited and periodic safety reports to competent authorities and ethics committees; and maintains records of all regulatory steps, particular correspondence, and applicable documentation. Through its medical writing service, FGK writes regulatory documents covering study protocols and study reports, investigator’s brochures, subject information and consent forms, investigational medicinal product dossiers, summaries for submission dossiers, briefing booklets, publication manuscripts, conference posters, and presentations. The company’s pharmacovigilance department monitors studies related to the safety of medicinal products and reports applicable events to regulatory authorities and ethics committees and compiles safety reports. Its quality assurance department carries out investigator site audits, database audits, systems audits, and vendor evaluations.
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