Management of the EAP
Once the ATU launched, Pharma Blue can handle the following activities:
- Eligibility check of proposed patients
- Assignment of a patient identifier to each participant
- Handling of pharmacist orders
- Order validation and transmission to the distributor
- Handling the forms and recording information in the database (data entry) (once ATU PTU agreed with ANSM)
- Follow up (calls or emails) to retrieve the forms from the pharmacists/physicians
- Create patient case folder & archiving
- Generate the ATU reports and file them to the relevant stakeholders.
