NAEMA BIWOLE

• Clinical Data programming for AIXIAL CRO

SAS programming.

EDC: Medidata RAVE, VIEDOC

• Setup: eCRF development, annotated CRF, basic structure, edit checks, pharmacovigilance notifications, User rights.
• Setup: Development of ePROs, implementation of workflow.
• Data collection: monitoring and updating UATs, table mapping, programming of listings, reconciliation of adverses events (serious/non-serious).
• Data Review: Data review plan, Data review presentation, implementation of conventions, recoding, Database lock

• Establishment of studies setup
• Design of test and final production bases
• eCRFs review, guidelines and specifications file
• Planning and programming of listings, data transfer (Import, export and reconciliation)
• Coding WHODRUG / MEDDRA
• Project management Study monitoring and maintenance activities

• Preparation of the entry of CRFs (definition of variables, coding)
• Design of electronic CRFs.
• Database import and content verification
• Implementation of queries due to missing data, inconsistencies or outliers
• Update the database with the answers to the queries, then freeze the database for statistical analysis
• Data description and statistical analysis
• Writing of data management plans, statistical analysis and end of study report
• Use of SAS and R software

• Assistance in the design of observation notebooks (definition of variables, coding)
• Updating clinical study databases with responses to queries, then formatting the database for statistical analysis
• Data analysis: Comparison of variables
• Use of Stata and SAS software

• Writing of the descriptive analysis report
• Description of the data
• Bibliographic search
• Use of R software