R-005-003 Work Leave Coordination - Jordi Barrachina
Leave start date: 2026-04-15
Gantt chart
Ongoing projects
Sant Pau study
Description: Clinical study being conducted in collaboration with Hospital de Sant Pau.
Role and responsibilities: Clinical oversight and coordination of the study documentation and communication with the site.
Current status: Patient recruitment was successfully completed in March 2026 with a target enrollment of 140 patients. The next steps involve a meeting with the Principal Investigator (PI) and the site monitoring team in April 2026, followed by a six-month monitoring phase leading to the study close-out in September 2026.
Expected milestones: Study completion meeting in April 2026. The site may raise queries during this period, which are typically operational in nature.
Contingency guidance: Alfonso Medela is designated to attend the meeting in April. If the hospital contacts us with questions—typically regarding data clarification or protocol interpretation—these queries should be escalated to the project lead.
Interim owner: To be assigned by direct manager.
EASI study Granada
Description: Clinical Multi-Reader Multi-Case (MRMC) study being conducted in collaboration with Hospital Virgen de las Nieves in Granada.
Role and responsibilities: Clinical oversight, ensuring correct study execution, coordinating study documentation, and managing communication with the site.
Current status: The contract with the hospital was signed in March/April 2026. The Site Initiation Visit (SIV) with the investigators will be held in April 2026. The upcoming phases include developing the annotation platform for study images, conducting the SIV (which includes platform training), monitoring the study throughout its duration, and finally holding the study completion and close-out meetings, which are expected in June or July 2026.
Expected milestones: Developing the annotation platform and conducting the Site Initiation Visit (SIV) and platform training in April 2026. The study will then enter a monitoring phase leading to completion and close-out meetings in June/July 2026. The site may occasionally raise operational queries during this period.
Contingency guidance: Alfonso Medela should be designated to attend the SIV in April, as he is the most up-to-speed on the study. If the hospital contacts us with questions—typically regarding data clarification or protocol interpretation—these queries should be escalated to the project lead.
Interim owner: To be assigned by direct manager.
Clinical study Vall d'Hebron
Description: Clinical study conducted in collaboration with Hospital Vall d'Hebron in Barcelona. The Principal Investigator (PI) is Dr. Álvaro Gómez Tomás.
Role and responsibilities: Clinical oversight, ensuring correct study execution, coordinating study documentation, and managing communication with the site.
Current status: The clinical trial agreement with the hospital is pending signature (anticipated in April/May 2026). Following the contract execution, a Site Initiation Visit (SIV) alongside a training session on the annotation platform for primary care practitioners is scheduled for May/June 2026. This will be followed by a monitoring phase throughout the study's duration, culminating in study completion and close-out meetings projected for November/December 2026.
Expected milestones: The immediate next steps include finalizing the contract signature with the hospital and research team. This will be followed by the SIV and platform training for investigators and primary care practitioners. Subsequent milestones include the active monitoring phase and the study close-out meeting in December 2026. Operational queries from the site are expected during this timeframe.
Contingency guidance: A designated coordinator should be appointed to oversee and finalize the contract execution with the research institute. For clinical inquiries from the hospital—typically regarding data clarification or protocol interpretation—these inquiries must be escalated to the project lead.
Interim owner: To be assigned by direct manager.
BSI clinical responses
Description: Preparation and submission of responses to BSI regarding the clinical evaluation section of the technical documentation.
- Key Documents:
R-TF-015-001 Clinical Evaluation PlanR-TF-015-003 Clinical Evaluation ReportR-TF-015-011 State of the Art Legit.Health Plus
Role and responsibilities: Drafting and reviewing the clinical responses to BSI's questions on the clinical evidence.
Current status: We are currently awaiting BSI's reply following their detection of non-conformities (NCs) that require resolution.
Expected milestones: The first round of NCs is expected from BSI in late March 2026. We will have a 15-day window to provide a response, aiming for submission by mid-April 2026.
Contingency guidance: If BSI responds with non-conformities during the absence, Saray or Taig can handle the initial review by consulting the existing documentation folder and coordinating with Brendan. Jordi Barrachina will remain available for ad-hoc consultation in case of critical clinical blockers or the need for complex NC interpretation.
Interim owner: To be assigned by direct manager.
FDA pre-submission
Description: Preparation of the FDA pre-submission (pre-sub) documentation for regulatory clearance in the United States.
Role and responsibilities: Drafting the clinical strategy for the pre-submission document and coordinating with Brendan on the regulatory strategy.
Current status: The clinical strategy document has been drafted, and the pre-submission is currently in preparation.
Expected milestones: The pre-submission should be finalized and submitted in May 2026. Once submitted, FDA feedback is expected approximately 30 days later. Upon receiving feedback, the response should be reviewed internally and discussed with Brendan.
Contingency guidance: If the pre-submission needs final review or if FDA responds during the absence, Taig can review the document and coordinate with Brendan on the response strategy.
Interim owner: To be assigned by direct manager.
Coordination of scientific manuscripts
Description: Coordination and review of scientific manuscripts related to technical and clinical validation studies, ensuring alignment with the overall clinical strategy and regulatory requirements.
Role and responsibilities: Supervision of and coordination with manuscript authors. This involves conducting monthly meetings to review progress, providing feedback on content to ensure scientific rigor and alignment with our clinical strategy, prioritizing manuscripts based on regulatory needs, and addressing any content gaps.
Current status: The most recent manuscript, authored by Ignacio, has been published under the title: "Enhanced Diagnosis of Generalised Pustular Psoriasis: Multi-Reader Multi-Case Evaluation of the Legit.Health Device as a Diagnosis Support Tool". Two additional manuscripts authored by Alberto Sabater are expected to be published in late March or April 2026: 1) "Overcoming measurement challenges in clinical trials: a deep learning-based approach for monocular surface area measurement", and 2) "Development and Assessment of an Automated Imaging Medical Device Based on Artificial Intelligence for Evaluating the Severity of Generalized Pustular Psoriasis". All related information is tracked in the Projected and Executed expenses spreadsheet, which is updated regularly.
Expected milestones: The immediate next steps include the publication of the first manuscript by Alberto Sabater in early April 2026, followed by his second manuscript in late April 2026. Continuous monitoring of manuscript progress and ongoing feedback will be required.
Contingency guidance: A designated coordinator should be appointed to oversee the progress of pending manuscripts, review content, and manage communication with the authors.
Interim owner: To be assigned by direct manager.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager
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