Clinfidence BV
Hanneke Lankheet-Buiel is a seasoned professional in data management with extensive experience in both academic and industry settings. Currently serving as a Senior Data Manager at Clinfidence BV since September 2022, Hanneke has held significant roles at Danone Nutricia Research from 2006, including Team Leader Data Management and Senior Data Manager. Prior positions include teaching as a Guest Teacher at Rotterdam University of Applied Sciences, and working as a Data Manager at Nutricia and VTVC. Hanneke began a research career as a Research Scholar at ICRISAT/Wageningen University and as a Researcher at the Instituut voor Plantenziektekunde. Educational qualifications include a PhD in Plant Breeding and an MS in Plant Breeding, both from Wageningen University & Research.
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Clinfidence BV
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.