Science Driven CRO

Science Driven CRO

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Medical Affairs

Medical Affairs

The Research Physician is a key member of any drug development team and forms the backbone for all medical and scientific aspects of clinical research projects. We provide scientific and medical input to all aspects of clinical studies and development programs from concept to conclusion.

Europital’s Medical Monitors form a scientific driving force behind all study phases with 24/7 medical guidance provided to investigational sites and the various study teams to ensure patient safety and scientific integrity of the study. Our Research Physicians perform expert medical review of clinical and safety study documents, the accumulated data and associated reports to ensure the quality of the study, the robustness of the data and the scientific value of the conclusions.

Role of the Medics

Physician-to-Physician scientific interactions are essential to establish a reliable partnership between Investigators and Sponsors. Europital medical liaisons ensure continuous site engagement via scientific interactions with investigators and site staff that facilitate essential knowledge transfer and resolving of potential obstacles that might impact the study.

  • Medical Expertise from concept to conclusion
  • 24/7 Medical Monitoring
  • Medical Review of documents and data
  • Medical Liaison and site engagement
  • Medical and Scientific Training

Scientific and Medical Guidance

IGMS Question Flow
1.Investigational site requests guidance4.Monitor requests guidance from Responsible TeamA.Answer found in existing project-specific knowledge base
2.Monitor consults project-specific knowledge base5.Digital round-table team deliberates to establish guidanceB.Answer provides to monitor & knowledge base is updated
3.Monitor searches established answer & guidance documentsC.Monitor provides requested guidance to site

Interactive Guidance Management System (IGMS)

An important service of Medical Affairs is providing scientific and medical guidance. Through an intuitive interface, our Interactive Guidance Management System (IGMS) PenThu® enables responsible physicians and study leads the means to smoothly provide medical and scientific guidance to the wider study teams across multiple projects with minimal effort, saving; time, energy and resources. Medical questions and guidance requests are automatically processed and managed in the IGMS via its interactive dashboard in a digital roundtable environment. The delivered guidance is automatically and instantly made available for the entire team via both online search and a formatted, downloadable Q&A Log.

Our IGMS provides start-to-finish guidance data capture with powerful tools for creating a project-specific knowledge base, in addition to full documentation of guidance processing, issue handling and decision making. With the integrated metrics, analytics and KPIs, the IGMS facilitates issue resolution, informated decision making and CAPA.

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