Data collection instruments (CRFs) design, electronic data capture (EDC) system selection and database design
Randomization implementation
Statistical analysis plan (SAP) development and review
Specialized software development
Study staff training
Review, monitoring, and quality assurance processes for data quality and validation
Data safety monitoring board (DSMB) organization and support
Planned interim analyses implementation and accrual modeling
Final analysis implementation using the OCTDI-validated software library and statistical report generation
Clinical study report (CSR) production
Manuscript and abstract preparation
Creation of datasets and documentation for sharing
Assistance with compliance and interactions with IRB, regulatory agencies and funding agencies
Training and Mentoring
Workshops: OCTDI personnel and associated scientists provide online workshops designed to turn new and established researchers within academia and industry into more educated consumers of clinical trial methodology.
Mentoring: The OCTDI is a training ground where mentees can gain firsthand experience and training in best practices.