 | Draft clinical portions of IND |
| Identify primary efficacy endpoints for regulatory approval |
| Write clinical study protocols |
| Construct Case Report Forms and other study specific documents |
| Identify experienced investigators |
| Place studies and negotiate investigator/CRO contracts |
| Provide medical monitoring |
| Review all study data (TLGs) for format and accuracy |
| Prepare clinical study report |
| Draft clinical portions of NDA |
| Draft manuscripts for publication |
