CLINICAL STUDY SETUP

We can help you with paper or electronic study setup activities with the initial setup of studies and ongoing support including

• Annotated CRF/e-CRFs
• Data management plans and CRF/eCRF completion guidelines
• Data specifications documents
• Procedure specifications (e.g., edit checks)
• Validation and derivation procedures
• Data extract views
• Test data preparation and testing

Our Data management experts have extensive study build experience using Oracle clinical / RDC / TMS and Medidata RAVE.