Efficient Solutions
A Clinical Partner Case Study of Expedited Clinical Trial Timelines
Key Highlights
- Phase I, single center, pharmacokinetic, pharmacodynamic, and safety evaluation study
- PK study with tight timeline requirements
- Approximately 19 weeks total from protocol development through final Clinical Study Report (CSR):
- Protocol developed and finalized in less than 4 weeks over holiday season (mid-December to early January)
- Complete EDC database released in 4 weeks from project initiation (just over 2 weeks from receipt of final protocol)
- FPFV to LPLV in approximately in 3 weeks
- LPLV to Database Lock in 1 week
- Database Lock to Top-line analysis delivery in 1 week
- Database Lock to Final analysis delivery (including PK results) in 2 weeks
- CSR finalized within 6 weeks of Final analysis delivery
* Durations listed above are approximate
Please note that this case study does not reflect SDC’s standard timelines for projects. However, it accurately reflects the team’s efforts for this particular project.