Review draft protocols for clarity and consistency for data collection. Identify new data that requires a new module for either entered or loaded data. Maintain and promote established Global Standards. Create timelines for study start-up activities. Facilitate meetings with project team for protocol specified assessments such as biomarkers, PK, exploratory samples to document vendor selection, timing of results and tracking requirements needed on CRF. Create CRF. Select and test derivations for study. Review database package based on final CRF and approve to move into production.