Our Services
Our Services
Clinical Data Services
- Clinical SAS
- SDTM Mapping and Programming
- Experience on both Production and Validation sides
- Support for studies across all clinical trial phases
- Services include:
- Domain designing and variable mapping
- Subdomain mapping
- Review of SDTM specifications
- CDISC data standardization
- Data QC and FDA submission
- ADaM Mapping and Programming
- Experience on both Production and Validation sides
- Support across all clinical trial phases
- Services include:
- ADaM domain design and variable mapping
- Creating/reviewing ADaM specs (CDISC standards)
- Tables, Listings & Figures (TLF)
- CRF Annotation
- Macro Creation
- Annotating TLF Shells
- FDA Submission Package (Define.xml, SDRG, ADRG)
- Preparing & Analyzing ISS/ISE
- SDTM Mapping and Programming
Study Lead Activities & Experience
- Calculate budget hours using SAP, protocol, and raw data
- Resource allocation
- Study folder structure setup
- Setup organizational goals and study timelines
- Schedule weekly/monthly team meetings
- Maintain study tracker
Service Models
- FSP Model
- CRO Model
- Corporation to Corporation Model
- W2 Model