Services
- Phase 0 through Phase 3 clinical study protocols and amendments
- Write or review clinical study proposals and reports (Phase 0 through Phase 3)
- Nonclinical or clinical data summaries
- Preparation of documentation to IRBs and FDA
- Preparation of documentation for IND submission
- Preparation of IND annual reports
- Drug development experiments
- Medical devices, in-vitro and in-vivo diagnostics, and combination drug/device products
- Preparation of grants, manuscripts and various scientific proposals