Unser Service beinhaltet:
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Studiendesign, inkl. Literaturrecherche
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Studienvorbereitung
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Risikobasierte Planung und Überwachung der Prozesse in allen Projektphasen
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Erstellung Leistungsstudienplan, Auswahl geeigneter Prüfzentren
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Statistische Beratung, inkl. Fallzahlplanung
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Anfertigung von Prüfarztverträgen, Erstellen von Case Report Forms (CRFs), Patienteninformationen und Einverständniserklärungen
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Zusammenstellung der Dokumentation, Antragstellung und Einreichung bei den zuständigen nationalen und internationalen Behörden und Ethikkommissionen
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Cross-funktionale Koordination des Studienteams
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Organisation von wissenschaftlicher Beratung
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Anfertigung des Studienberichts
Study Management
Our experienced study managers design, plan and coordinate according to your requirements to ensure the success of analytical and clinical performance studies
Biostatistics
Expert biostatistics consultation including statistical analysis planning, case number calculation, data analysis, and reporting.
Study Monitoring
Our team of Clinical Research Associates manages study sites and documentation for full compliance (monitoring plan, TMF, SAV, SIV, SDV, COV).
Data Management
Complete data management including data management plan, eCRF set-up and management, and database management.
Regulatory Support
We take care of study related submissions to ethics committees/institutional review boards and national competent authorities, as well as technical meetings, e.g., with notified bodies (EU), BfArM/PEI (Germany), FDA (Pre-Sub).
IVDR Readiness Consultation
Classification of products and IVDR gap analysis of technical documentation. Project management coordinating development partners and the liaison with regulatory authorities.
