Support Services
Protocol Writing
- Study design and feasibility assessment
- Write at Jasper/perform at another site
- Jasper or sponsor formats and templates
CRF, Data Management
- Electronic or paper CRFs
- Jasper or sponsor formats
- Database creation and warehousing
- Secure website for access to study data
- Direct-to-sponsor database entry
- Low query rate/fast resolution of data queries
PK/PD Analysis
- WinNonlin analysis software
- Experienced pharmacokineticists
- Analysis and interpretation
- Production of PK section of clinical study reports
- Study design consultation
Report Writing
- Interpretation of results
- Jasper or sponsor formats and templates
- Full report compilation
- Manuscript preparation
Cardiac Safety, QT Studies
- Continuous cardiac telemetry experience
- 32 beds on digital telemetry
- Holter monitoring capability
- Work with multiple ECG providers for ECG over-read services
- Thorough QTc design assistance
Biomarkers, Genetics, Imaging
- Genotyped volunteers
- Archived DNA/rapid Genotyping Services
- Archived DNA/rapid genotyped volunteers
- Specialized biomarker sample preparation
- Broad-based imaging modalities
- Phase 0 studies
Exploratory, Adaptive Designs
- Design modification of ongoing studies
Clinical Development Plans
- Optimization of pre-clinical activities leading to IND
- Write-from-Scratch Planning
- Feasibility assessment consultation services
- Phase I activities in Phase II/III studies
- FDA submission services
- Proof of concept/Target/Design
- FDA Critical Path Initiative alignment
