General Consulting Services Assessment Services Specific to Needs Specification Creation Process/ Gap Analysis Documentation Creation Team Augmentation Adaptive Clinical Trials ? Project realization from protocol to database ? Database object creation and development ? Data validations creation and testing ? Visit schedule structure creation ? Specification creation, control and approval ? Version control and traceability of data specification and storage ? Scanning and mailing controls to verify original documentation for source data ? CDISC (SDTM Implementation) variables and domain confirmations for submission standard compliance ? Current 'Best Practices' and FDA preferences for Database Architecture and validation