1. Consulting services regarding the scientific concept.

2. Complete design of the study protocol:
• Determination of the appropriate statistical study design, depending on study objectives.
• Development of the clinical section of the protocol, including literature support.
• Development of the administrative/ procedural sections of the protocol.
• Development of the statistical sections of the protocol and estimation of the sample size.
• Design and formatting the paper CRF.

3. Design and development of the electronic CRF (cloud e-CRF). It is a 21 CFR Part 11 compliant flexible clinical data collection and data management system. The system is validated by applying an ISPE GAMP5 GxP validation process and is also compliant with all FDA and EMA requirements.

4. Development of the Statistical Analysis Plan (SAP).

5. Development of any other Study document / form, such as monitoring plan, statistical monitoring report, questionnaires, etc.

6. Designing and consulting the monitoring process.

7. Statistical analysis, development of the corresponding report (SAR) and presentation of the results.

8. Development of the final Clinical Study Report (CSR).