CONSULTING

Advisory role across DM and database programming activities/approaches, document preparation/review, EDC selection

eCRF review against CDISC standards, eCRF design, CDISC compliant library design/review

Review of documentation and databases, SOP and template development/review.

Manage and drive database builds and cleaning activities, prepare timelines and ensure deliverables on time/budget, conduit between client and vendor(s)

Cost up DM and database programming activities

Statistical consultation, PK advice, sample size calculations, SDTM/ADaM programming