{"id":5101,"date":"2026-01-11T22:06:31","date_gmt":"2026-01-11T21:06:31","guid":{"rendered":"https:\/\/neurodm.fr\/the-process\/"},"modified":"2026-02-16T17:10:37","modified_gmt":"2026-02-16T16:10:37","slug":"the-process","status":"publish","type":"page","link":"https:\/\/neurodm.fr\/en\/the-process\/","title":{"rendered":"The Process"},"content":{"rendered":"\t\t
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The Evaluation Process<\/span><\/span><\/h2><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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NeuroDM was designed to remove the usual barriers to clinical evaluation. Our process guarantees high-level scientific analysis and economic validation in less than a month, thanks to agile governance and streamlined interactions with regulatory authorities (ANSM\/CPP). <\/p><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\"Intro\"<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t
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Our Process<\/span><\/span><\/span><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Your <\/span><\/span> journey <\/span><\/span> from <\/span><\/span> idea <\/span><\/span> to <\/span><\/span> the <\/span><\/span> operating <\/span><\/span> room <\/span><\/span> <\/h3><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The \"Step-by-Step\"<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Qualification <\/span><\/span> <\/h4><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Submission of your application via our online form.<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Verification of completeness by R. Guizem<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Strategic <\/span><\/span> Arbitration <\/span><\/span> <\/h4><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Presentation of your project to the Governance Committee<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Evaluation of clinical interest and technical feasibility<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Engineering <\/span><\/span> & <\/span><\/span> Design <\/span><\/span> <\/h4><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Methodological scoping with the CEDM or the DRCI of the HFAR.<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Budget establishment and signing of the agreement <\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Regulatory <\/span><\/span> Go-Ahead <\/span><\/span> <\/h4><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Submission to authorities (ANSM \/ CPP) by the DRCI Promotion Department or the DRCI of the HFAR.<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Clinical <\/span><\/span> Phase <\/span><\/span> <\/h4><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Opening of centers, inclusions, and monitoring by our dedicated CRAs.<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Our Added Value<\/h4><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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NeuroDM does more than just evaluate your project; it provides an immediate boost to transform your innovation into clinical reality.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Accelerated Expertise<\/h5>
Reducing Uncertainty, Maximizing Time. In the development of a medical device, every month counts. NeuroDM was specifically designed to remove the administrative and scientific hurdles that traditionally slow down access to the clinical field. <\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Parallel Engineering <\/h5>
While we evaluate medical relevance, our experts at the CEDM (URC Lariboisi\u00e8re) are already analyzing regulatory and methodological feasibility.<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Governance Responsiveness <\/h5>
Your application benefits from a rapid critical analysis by our committees, allowing clinical interest to be validated in record time.<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Institutional Fast-Track <\/h5>
This single point of contact centralizes expertise from the AP-HP and the Rothschild Foundation, eliminating unnecessary back-and-forth. You receive a clear diagnosis on the viability of your project and a precise execution schedule, where traditional circuits often impose several months of waiting.<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\tNeuroDM in several phases<\/span><\/span><\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The <\/span><\/span> NeuroDM <\/span><\/span> Service <\/span><\/span> Showcase <\/span><\/span> <\/h3><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Your Investigation Catalog<\/span><\/p><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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<\/svg>Pre-Market Phase<\/a><\/div>
<\/svg>Post-Market Phase<\/a><\/div><\/div>
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Objectif: Marquage CE et Preuve de Concept<\/h3>
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\u00c9tudes de Faisabilit\u00e9 (First-in-Human)<\/h5>
Premi\u00e8re utilisation du dispositif chez l'homme dans un environnement s\u00e9curis\u00e9.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Investigations Cliniques Pivotales <\/h5>
\u00c9tudes de grande envergure pour d\u00e9montrer la performance et la s\u00e9curit\u00e9 en vue du marquage CE (RDM 2017\/745)<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Design de Protocole & M\u00e9thodologie <\/h5>
Co-r\u00e9daction du protocole avec les experts du CEDM et de l\u2019HFAR pour s'assurer que les crit\u00e8res d'\u00e9valuation (endpoints) sont solides.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Soumissions R\u00e9glementaires : <\/h5>
Gestion compl\u00e8te du dossier ANSM (Autorit\u00e9 de sant\u00e9) et CPP (Comit\u00e9 de Protection des Personnes).<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Acc\u00e8s aux Plateaux Techniques <\/h5>
Utilisation des blocs op\u00e9ratoires de pointe, de l'imagerie interventionnelle et de la robotique dans nos centres d'investigations.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Objectif : Remboursement et Rayonnement<\/h3>
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Suivi Clinique Apr\u00e8s Commercialisation (PMCF) <\/h5>
Collecte syst\u00e9matique de donn\u00e9es cliniques pour confirmer la s\u00e9curit\u00e9 \u00e0 long terme.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u00c9tudes de \"Vraie Vie\" (Real World Evidence) <\/h5>
Analyse de l'utilisation du dispositif dans la pratique quotidienne des chirurgiens.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u00c9tudes M\u00e9dico-\u00c9conomiques : <\/h5>
D\u00e9montrer l'efficience du dispositif m\u00e9dical pour obtenir un remboursement par la S\u00e9curit\u00e9 Sociale.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Observatoires et Registres <\/h5>
Mise en place de bases de donn\u00e9es de suivi de cohortes sur plusieurs ann\u00e9es.<\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/div><\/div><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Technical Pillars<\/h3>
Institutional Excellence at your service:<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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<\/g><\/svg><\/div>Rigor: The Promotion Department of the AP-HP DRCI and the DRCI of the HFAR secure your trials.<\/span><\/div>
<\/g><\/svg><\/div>Expertise: The CEDM (URC Lariboisi\u00e8re) and the URC of the HFAR optimize your methodology.<\/span><\/div>
<\/g><\/svg><\/div>Agility: A single point of contact for two institutions (APHP & Rothschild)<\/span><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Submit your application today for an initial response within 8 days.<\/span><\/p><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Human <\/span><\/span> and <\/span><\/span> connected <\/span><\/span> management <\/span><\/span> <\/h2><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\"Razika<\/div><\/div><\/div><\/div>
Razika Guizem<\/h5>
Project Manager<\/strong><\/h6>

Single Point of Contact: From the moment you submit, you are supported by our project coordinator, Razika Guizem. She serves as the continuous link between the scientific and administrative teams and you.<\/p>

<\/svg><\/a><\/svg><\/a><\/div><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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<\/svg>Contact us<\/span><\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

The Evaluation Process NeuroDM was designed to remove the usual barriers to clinical evaluation. Our process guarantees high-level scientific analysis and economic validation in less than a month, thanks to agile governance and streamlined interactions with regulatory authorities (ANSM\/CPP). The…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5101","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/pages\/5101","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/comments?post=5101"}],"version-history":[{"count":16,"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/pages\/5101\/revisions"}],"predecessor-version":[{"id":5313,"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/pages\/5101\/revisions\/5313"}],"wp:attachment":[{"href":"https:\/\/neurodm.fr\/en\/wp-json\/wp\/v2\/media?parent=5101"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}