Nicole Spelier-Claessens

Clinfidence emphasizes the importance of data management in clinical trials. We offer clinical data management services, thereby following the relevant laws and regulations (e.g. ICH GCP and 21CFR Part 11). Clinfidence has extensive experience in helping companies and researchers with clinical data management processes of phase I-IV studies across different therapeutic areas. We deliver our services in several widely accepted electronic data capture systems. SERVICES ♣ Development of Data Management Plan ♣ eCRF/ePRO Design and Setup ♣ Development of Data Validation Plan ♣ User Acceptance Testing of eCRF/ePRO and Data Validation Checks ♣ eCRF/ePRO Training for Users ♣ Review and Maintain User Access to eCRF ♣ Integration of Electronic Data from Central Lab in the eCRF ♣ Continuous Data Review, Including Review of Resolved Queries) ♣ Coding of Medical Terminology (Adverse Events, Medical History, Medications) ♣ Generation of Status Reports ♣ Serious Adverse Event Reconciliation between eCRF and Safety Database ♣ Database Lock ♣ Data Exports Clinfidence can assist researchers in data management activities of their Investigator Initiated Trials. Clinfidence helps the researcher in the generation and execution of the Data Management Plan (DMP), which describes the data management activities in the context of the Investigator Initiated Trial.