Case Study
Objective: To collect additional data requested by the FDA to support a complete BLA data package.
What has been done:

1. The project was initiated under a humanitarian program.
2. A two-week setup process was completed, which included document preparation, engagement with English-speaking doctors, obtaining authorities' permissions, and establishing a MSA.
3. Creation of a secured data transmission option for data collection occurred within one month, carried out in parallel with other preparations.
4. The device was delivered from the USA to hospitals on the battlefields in
Ukraine within one week.
5. Surgeons received training.
6. Immediate patient enrollment, given the urgency of the war situation, and due to the high number of patients in need.
7. The product's real effectiveness was tested.
8. Data management was implemented.
9. The results were transmitted to the client for further promotional activities, emphasizing that the product has been tested in war zones.
The collected data has been accepted by the FDA and will enable the Sponsor to proceed with the market authorization submission.
Case study 2
business woman during pandemic
Duration of the whole project: 6 months
Objective: To collect additional data requested by the FDA to support a complete BLA data package.
Case study 1
business woman during pandemic
Duration of the whole project: 6 months
What has been done:

1. The project began as a humanitarian aid program, during which 19 patients received treatment.
2. The subsequent project was conducted as a retrospective clinical trial.
3. Study startup, including feasibility assessment, took one month.
4. Obtaining IRB (LEC/EC) approvals also took one month.
5. Patient enrollment: 17 patients were enrolled within two weeks (out of the 19 who received treatment as part of the humanitarian aid program).
6. All data were collected according to the Sponsor's schedule within 1.5
months.
The collected data has been accepted by the FDA and will enable the Sponsor to proceed with the market authorization submission.