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