Differentiator, Services, and Indication Expertise

  Ability to communicate complex statistical concepts in a consumable fashion.

1. FDA meeting preparation and attendance (CDER and CDRH)
2. Program strategy, accounting for safety and efficacy requirements.
3. Protocol Study Design Strategy Development:
   1. Endpoint Determination
   2. Sample Size and Power
   3. Multiple Endpoints/Accounting for Multiplicity
   4. Adaptive Designs
   5. Interim Analyses
4. Documentation Development / Review:
   1. Protocol
   2. Randomization Plan
   3. Statistical Analysis Plan
   4. Table, Listing, and Figure (TLF) Shells
   5. Case Report Forms (Review Only).
5. Data Monitoring Committee Board Member, Documentation Development / Review
6. Outcome (TLFs) and Clinical Study Report Review and Input
7. Adhoc and Posthoc Analyses
8. Integrated Summaries of Safety (ISS) and Efficacy (ISE) Strategy
9. Formal TLF development through recommended CROs.
10. Data Package (SDTM/ADaM Versions and IG) Review and Development through recommended CROs.
11. Advisory Committee Defense 

1. Glaucoma / Ocular Hypertension (including Neuroprotection)
2. Dry Eye
3. nAMD, DME, RVO
4. Dry AMD / GA 
5. Keratoconus 
6. Ocular Allergy, Bacterial Conjunctivitis 
7. Post-Op Inflammation & Pain, Anterior and Posterior Uveitis 
8. Blepharitis, Demodex Blepharitis
9. Presbyopia, Myopia
10. Persistent Corneal Epithelial Defect