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SERVICES

Clinical Research Management and Consulting

  • Overall study management, including planning and design

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  • Preparation of Study Protocols, Informed Consent Forms (ICF), Investigator Brochures (IB), Case Report Forms (CRF)

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  • Handling of Study Agreement

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  • Preparation of Final Clinical Study Reports and Clinical Evaluation Reports (CER)

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  • Monitoring (CRA) visits

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  • Medical Monitoring (MD)

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  • Set-up of clinical departments

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  • Development of clinical SOPs (Standard Operating Procedures)

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  • Preparation and management of essential study documents

Clinical Quality Assurance (CQA) Audit of Clinical Trials

  • In-house audits

    • Sponsor/Monitor audits

    • Investigator file audits

    • Informed consent audits

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  • Site Audits

    • Auditing of Case report forms and source documents

    • Auditing of Informed consent forms

    • Auditing facilities and equipment

    • Auditing site personnel qualification and training

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  • Audits of study reports

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  • Communication of audit findings by oral and written reports

Scientific Medical Writing

  • Manuscripts for peer-reviewed journals

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  • Clinical study reports

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  • Clinical summaries and overviews

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  • Safety narratives and periodic safety update reports (PSURs)

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  • Presentation of scientific data

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  • Literature review and analysis

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  • Academic works, including M.Sc. / Ph.D. thesis

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