1. Scientific and Strategic consulting. • Analysis of scientific gaps arising from pivotal clinical studies, clinical guidelines and real-world clinical practice. • Gap Assessment & Evidence Mapping, with systematic mapping of the needs and opportunities for further evidence generation. • Development of a comprehensive RWE strategy aligned with the objectives of the product's Life Cycle Management.
2. Study Protocol Development.: • Determination of the appropriate statistical methodology, based on study objectives. • Development of the clinical and scientific sections of the protocol, supported by relevant scientific literature. • Development of the administrative/ procedural sections of the protocol. • Development of the statistical sections of the protocol including estimation of the sample size. • Design and formatting the Case Report Form (CRF). • Informed Consent Form (ICF) design and formatting
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. SPECIFICATIONS: e-CRF clinical platform is based on Oracle’s RDBMS. Entire infrastructure is securely hosted in Oracle's Cloud Infrastructure - OCI (servers are located in the European Union - Frankfurt/DE).
The service is fully compliant with international standards and guidelines related to the organization and management of clinical studies such as: • FDA, Guidance for Industry “Computerized Systems Used in Clinical Investigations”, May 2007 • FDA, 21 CFR Part 11, "Electronic Records; Electronic Signatures; Final Rule." March 20, 1997. • FDA, Part 11, Electronic Records; Electronic Signatures — Scope and Application, 2003. • ICH E6 Good Clinical Practice: Consolidated Guidance • GDPR General Data Protection Regulation, EU 2016/679 • EMA/INS/GCP/112288/2023: Guideline on computerized systems and electronic data in clinical trials
4. Development of the Statistical Analysis Plan (SAP).
5. Development of all Study Monitoring documents / forms: Monitoring plan, Initialization Visit report, Interim Monitoring Visit Report / Telephone Contact Report, Close-out Visit Report, Patients questionnaires, etc.
6. Development of the tripartite/quadruple contracts
7. Study Monitoring and Site Management: • Investigator Site Files set-up and placement of essential documents / maintenance and update throughout the whole conduct of the study • Trial Master File set-up and placement of essential documents / maintenance and update throughout the whole conduct of the study • Submissions to Hospital Ethics Committees • Receipt of approved Study/ Site Agreement template, submissions to the relevant financial and administrative bodies and follow up with all parties until approvals granted / their full execution. • Monitoring of the agreement execution process. • Initiation Visits, Interim Monitoring Visits / Telephone Contacts, Close-out Visits.
8. Project Management and Statistical Reporting. Keeping the Sponsor informed about the progress of the study is one of the Company's main objectives. For this reason, statistical methods are not only used for the sample size calculation and the development of the Statistical Analysis Plan (SAP), but also during the monitoring process, providing the Sponsor with clear and comprehensive oversight of study progress: DIAMOND Study: Recruitment Rate/Number of Patients. 15/01/2026 - 30/05/2026 (and linear prediction for number of patients on 1st Visit). DIAMOND Study: GANTT CHART / Timetable for the implementation of the Tasks.
9. Statistical analysis, development of the corresponding report (SAR) and presentation of the results.
DIAMOND Study: Survival curves. Time to disease exacerbation, by age group.
10. Development of the final Clinical Study Report (CSR). 11. Medical writing and Scientific Publication Support • Phase 1: Preparation & Target Journal Selection • Phase 2: Manuscript Drafting (The Inside-Out Method) • Phase 3: Internal Review & Revision • Phase 4: Manuscript Submission & Peer Review • Phase 5: Production & Publication 12. Regulatory Compliance with applicable national and international regulations, guidelines, and standards.
