Service Areas
Data Management
- Electronic data capture (EDC)
- Case report form design
- Database design and programming (SDTM/CDISC-Compatible)
- CRF/Query/Resolution tracking
- Comprehensive data cleaning
- Laboratory value loads
- Medical coding (MedDRA, WHO Drug)
- Database QC/lock/freeze
- 3rd party data reconciliation
- Data reporting
- Integration of different data sources
Biostatistics
- Study design, Statistical analysis plans
- Randomization schedules
- Programming/validation of TLFs and derived datasets for clinical study reports
- Statistical consulting
- Planning and implementing interim analyses, PK/PD Modeling-Analysis
- IND annual reports
- IB Support, DSMB support, Publication support
- Integrated summary of safety/integrated summary of efficacy (ISS/ISE)
- CDISC mapping
- Regulatory requests
Medical Writer
- Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.
- Represents medical writing in cross-functional teams.
- Demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines.
- Writing Project development plan, Protocol/synopsis, and CTD.