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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
    • CAPA Plan - BSI CE Mark Closeout
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
      • Software
      • Artificial Intelligence
      • Cybersecurity
      • Usability and Human Factors Engineering
      • Clinical
        • Evaluation
          • Appendix
            • CV-Ana Vidal
            • CV-Antoine Giraud
            • CV-Antonio Martorrell
            • CV-Céline Fabre
            • CV-Coralie Cantarel
            • CV-Fabienne Diaz
            • CV-Jordi Barrachina
            • CV-Saray Ugidos
            • Declaration of Interests-Ana Vidal
            • Declaration of Interests-Antoine Giraud
            • Declaration of Interests-Antonio Martorell
            • Declaration of Interests-Céline Fabre
            • Declaration of Interests-Coralie Cantarel
            • Declaration of Interests-Fabienne Diaz
            • Declaration of Interests-Jordi Barrachina
            • Declaration of Interests-Saray Ugidos
          • R-TF-015-001 Clinical Evaluation Plan
          • R-TF-015-003 Clinical Evaluation Report
          • R-TF-015-011 State of the Art Legit.Health Plus
          • R-TF-015-013 Statistical Summary of Clinical Evidence
        • Investigation
      • Commissioning
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
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  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Clinical
  • Evaluation
  • Appendix
  • CV-Coralie Cantarel

Curriculum Vitae

Personal Information​

Name: Coralie Cantarel Professional Title: Biostatistician Current Position: Biostatistician Institution/Organization: Horiana (Health Data Consulting) Email: coralie.cantarel@horiana.com

Professional Qualifications​

Scientific Degree(s)​

  • Degree: Master's Degree in Public Health (specialty: Epidemiology) Institution: ISPED – University of Bordeaux Year: 2018

  • Degree: Bachelor's Degree in Life Sciences, Molecular and Cellular Biology and Physiology Institution: University of Bordeaux Year: 2016

  • Degree: Higher National Diploma (BTS) in Biotechnology Institution: Bordeaux Year: 2015

Additional Qualifications and Certifications​

  • Statistical methodologies: Study design, Statistical Analyses Plan (SAP), sample-size calculation, randomisation lists, descriptive and inferential analyses, study reporting and dissemination; survival analysis (Kaplan–Meier, Cox, Fine-Gray); logistic and GLM regression; propensity scores; hypothesis testing; non-parametric tests; mixed models for repeated measures.
  • Standards: CDISC SDTM and ADaM.
  • Languages and tools: Professional working proficiency in English; SAS (Base, Macro, Graph, Stat), STATA, R, SQL, nQuery Advisor, EAST, PASS.

MDR Annex XIV Compliance — Qualifications of Clinical Evaluators​

As per MDR 2017/745 Annex XIV Section 1, the following qualifications are confirmed:

a) Appropriate scientific education:

  • Scientific qualification: Master's Degree in Public Health (specialty: Epidemiology), ISPED – University of Bordeaux (2018).
  • Field of specialisation: Biostatistics, epidemiology, clinical research methodology.

b) Training and experience in clinical research methodology:

  • Years of experience: 8 years in clinical trials and observational studies.
  • Methodological expertise: Statistical design and analysis of Phase I–III clinical trials and observational studies; SAP development; sample-size calculation; randomisation; mixed models for repeated measures; national-database secondary analyses; CDISC ADaM/SDTM.
  • Clinical-trial experience: 7 years at Bergonie Institute (oncology and sarcoma specialist centre), covering prospective and observational research.

c) Competence in the relevant medical field and knowledge of the device:

  • Therapeutic-area experience: Oncology, orthopaedics, obstetrics, ophthalmology.
  • Medical-device experience: The external methodological review engaged was scoped to a Class IIb medical device software clinical evaluation.
  • Understanding of intended use and clinical performance: The external review deliverables addressed statistical validity, study-design appropriateness, evidence ranking and adequacy of the clinical evidence base for the intended use.

d) Understanding of regulatory requirements:

  • CDISC standards: SDTM and ADaM.
  • MEDDEV/MDCG: External review scope covered MEDDEV 2.7/1 Rev 4, MDCG 2020-1 (three-pillar framework) and MDCG 2020-6 Appendix III (evidence hierarchy).

Professional Experience​

Current Position​

Position: Biostatistician Institution: Horiana (Health Data Consulting), Bordeaux (France) Duration: Since July 2025

Previous Relevant Positions​

Position: Biostatistician / Epidemiologist Institution: Bergonie Institute, Bordeaux (France) Duration: July 2018 – June 2025 Key Responsibilities: Statistical analyses for Phase I–III clinical trials and observational studies in oncology (sarcoma, phase I trials), obstetrics, orthopaedics and ophthalmology; national-database analyses (French national databases); SAP development and study reporting.

Clinical Evaluation and Research Experience​

Experience with Medical Devices​

  • Years of experience: External methodological review of a Class IIb MDSW clinical evaluation (2026).
  • Regulatory experience: MEDDEV 2.7/1 Rev 4; MDCG 2020-1; MDCG 2020-6; CDISC standards.

Clinical Research Experience​

  • Phase I–III clinical trials: 7 years at Bergonie Institute, covering study design, SAP development, randomisation, survival analyses and national-database secondary studies.
  • Observational studies: Cohort, case-control and secondary-database analyses including studies on French national databases.
  • Role: Biostatistician/Epidemiologist (primary analysis, SAP, reporting, dissemination).

Expertise Relevant to This Evaluation​

Technical Expertise​

  • Statistical methodology for clinical evidence: Study design, sample-size calculation, SAP development, mixed models, survival analysis — applied to assessing whether the gathered clinical evidence is sufficient for the intended use.
  • Evidence adequacy assessment: 8 years of experience evaluating the statistical validity of primary clinical data and identifying methodological limitations across Phase I–III trials and observational studies.

Regulatory Knowledge​

  • MEDDEV 2.7/1 Rev 4: Clinical-evaluation methodology.
  • MDCG 2020-1: Three-pillar framework for Medical Device Software clinical evidence.
  • MDCG 2020-6 Appendix III: Hierarchical evidence ranking.
  • CDISC SDTM and ADaM: Clinical data standards for regulatory submissions.

Publications and Communications (Selected)​

Oral Communications​

  • 2022 Congrès EPICLIN, Paris — Suivi sur un an de la séroprévalence de l'infection par le SRAS-CoV-2 et de l'anxiété chez les personnels de santé d'un centre de lutte contre le cancer (PRO-SERO-COV).

Selected Peer-Reviewed Publications​

  • Evrard S, Bellera C, Desolneux G, Cantarel C et al. Anastomotic leakage and functional outcomes following total mesorectal excision for rectal cancer. Eur J Surg Oncol. 2023;49(11):107015.
  • Penel N, Cantarel C et al. Impact of the COVID-19 pandemic on sarcoma management in France. Ther Adv Med Oncol. 2023;15:17588359231192400.
  • Richez B, Cantarel C et al. One-Year Follow-Up of Seroprevalence of SARS-CoV-2 among Health Workers of a French Cancer Center (PRO-SERO-COV). Int J Environ Res Public Health. 2023;20(11):5949.
  • Italiano A, Bessede A, …, Cantarel C et al. Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures (PEMBROSARCⅡ). Nat Med. 2022;28(6):1199–206.
  • Cousin S, Cantarel C et al. Regorafenib-Avelumab in patients with biliary tract cancer (REGOMUNE). Eur J Cancer. 2022;162:161–9.
  • Cousin S, Cantarel C et al. Regorafenib-Avelumab in patients with microsatellite stable colorectal cancer (REGOMUNE). Clin Cancer Res. 2021;27(8):2139–47.
  • Lebreton C, Cantarel C et al. Incidence and prognostic factors of clinically meaningful toxicities of kinase inhibitors in older patients (PreToxE). J Geriatr Oncol. 2021;12(4):668–71.

Languages​

  • French: Native
  • English: Professional working proficiency

Declaration​

I declare that the information provided in this curriculum vitae is accurate and complete to the best of my knowledge.

Name
Coralie Cantarel
Role
Biostatistician, Horiana
Place
Bordeaux (France)
Digital Signature
[ Place Digital Signature Here ]{{Sig_es_:signer:signature}}

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CV-Fabienne Diaz
  • Personal Information
  • Professional Qualifications
    • Scientific Degree(s)
    • Additional Qualifications and Certifications
    • MDR Annex XIV Compliance — Qualifications of Clinical Evaluators
  • Professional Experience
    • Current Position
    • Previous Relevant Positions
  • Clinical Evaluation and Research Experience
    • Experience with Medical Devices
    • Clinical Research Experience
  • Expertise Relevant to This Evaluation
    • Technical Expertise
    • Regulatory Knowledge
  • Publications and Communications (Selected)
    • Oral Communications
    • Selected Peer-Reviewed Publications
  • Languages
  • Declaration
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)