Phase II


Milestones and Milestone Events - Phase IIa

1. Engage CRO
2. Define Investigators
3. Draft and finalise protocol for Clinical Trial
4. Draft and finalise Investigative Brochure (IB)
5. Engage Clinical Trial Suppliers
6. Protocol for clinical trial submitted to Ethics Committee
7. Ethical Committee approval
8. Investigator meeting with CRO
9. Deliver clinical supplies to Investigator sites
10. Patient recruitment and randomisation
11. Dispatch biological samples to central laboratory throughout investigation for:
Plasma samples (PK)
Bone biomarkers
12. Collate bone mineral density data, clinical chemistry and study specific data
13. Close out investigator sites
14. Bio-statistic analysis and reporting
15. Clinical report
16. Complete Trial Master File (TMF)
Phase II