Page 111 - AI for Good Innovate for Impact

AI for Good Innovate for Impact

promote responsible AI use in clinical research. User feedback has been central to FiCRO’s
evolution. Pilot users highlighted the need for clearer cost transparency and better alignment
with therapeutic areas. In response, FiCRO implemented a weighted scoring system and
redesigned its user interface to improve matching accuracy and overall usability. 4.1-Healthcare

Additionally, learnings from medical device-specific documentation efforts (via the B company
AX Project) informed the development of class-based protocol templates aligned with regional
regulatory standards.

3 Use Case Requirements

• REQ-01: The system must support access to anonymized and structured clinical trial data
for AI model training and validation.
• REQ-02: It must include secure APIs for accessing and ranking CRO databases.
• REQ-03: The system must comply with international standards and regulations for
data protection and clinical research, including GCP, GDPR and HIPAA. This ensures
responsible data handling, ethical governance and auditability.
• REQ-04: The system must be deployed on a secure, cloud-based infrastructure capable
of supporting AI model inference, storage and real-time processing across multiple
geographic regions.
• REQ-05: The platform must provide an intuitive user interface and support seamless
integration with existing Clinical Trial Management Systems (CTMS), Electronic Data
Capture (EDC) systems and sponsor dashboards.
• REQ-06: The system must include a structured feedback mechanism to capture user
inputs and real-world data, enabling iterative improvement of AI model accuracy,
contextual relevance and explainability.

4 Sequence Diagram

MediC (Main) – Functional Sequence Diagram

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