{"id":4185,"date":"2026-05-24T08:32:37","date_gmt":"2026-05-24T05:32:37","guid":{"rendered":"https:\/\/demo.erayonetim.com\/?post_type=event&p=4185"},"modified":"2026-07-08T10:13:32","modified_gmt":"2026-07-08T07:13:32","slug":"clinical-data-collection-and-clinical-research-services","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/klinik-veri-toplama-ve-klinik-arastirma-hizmetleri\/","title":{"rendered":"Clinical Data Collection and Clinical Research Services"},"content":{"rendered":"
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\ud83e\uddea Clinical Data Collection and Clinical Research Services<\/h4>\n

MDR, IVDR, FDA ve ISO 14155’e Uygun, \u00dcr\u00fcne \u00d6zg\u00fc Klinik Strateji Tasar\u0131m\u0131<\/h4>\n

Clinical data are indispensable for proving the safety and performance of medical devices, in accordance with MDR (2017\/745), IVDR (2017\/746), ISO 14155, and FDA regulations. At Era Management, we operate with a versatile CRO approach experienced in clinical data management specific to medical devices; we plan your clinical research, PMCF, and data collection strategies end-to-end as needed.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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\ud83d\udd0d Product-Specific Clinical Approach<\/h3>\n\n\n\n\n\n\n\n\n
Criterion<\/th>\nIts effect<\/th>\n<\/tr>\n
Product Class<\/td>\nClinical data determines the need for and depth of the study.<\/td>\n<\/tr>\n
Legacy Product Status<\/td>\nIs bridging possible based on the existing data?<\/td>\n<\/tr>\n
Proof of Similarity (Equivalence)<\/td>\nIs it possible to use literature\/equivalent products?<\/td>\n<\/tr>\n
Market Time and Usage History<\/td>\nThe use of retrospective data and the necessity of PMCF.<\/td>\n<\/tr>\n
Intended Use \/ Risk Profile<\/td>\nIs a clinical trial sufficient, or is a literature review adequate?<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>
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\ud83d\udcd8 Our Services<\/h3>\n

\ud83d\udcd1 Clinical Assessment (MDR\/IVDR)<\/h4>\n
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  • \u2022 Klinik de\u011ferlendirme plan\u0131 (CEP) & raporu (CER)<\/li>\n
  • \u2022 Evaluation of existing data, literature, and equivalence.<\/li>\n
  • \u2022 Expert opinion and methodological validity analysis<\/li>\n<\/ul>\n

    \ud83d\udd2c Clinical Research (ISO 14155)<\/h4>\n
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    • \u2022 Prospective\/Retrospective study, PMCF studies<\/li>\n
    • \u2022 eCRF, consent forms, ethics committee support<\/li>\n
    • \u2022 File structure suitable for reporting and NB\/FDA submissions.<\/li>\n
    • \u2022 Development of a clinical research strategy<\/li>\n
    • \u2022 Preparation of Clinical Research Protocol<\/li>\n
    • \u2022 Establishing evaluation criteria and conducting literature reviews.<\/li>\n
    • \u2022 Preparation of the Informed Consent Form (ICF)<\/li>\n
    • \u2022 ORF (Case Report Form) design<\/li>\n
    • \u2022 Sampling calculation<\/li>\n
    • \u2022 Statistical analysis plan<\/li>\n
    • \u2022 Randomization<\/li>\n
    • \u2022 Ethics committee applications<\/li>\n
    • \u2022 T\u0130TCK applications<\/li>\n
    • \u2022 Job commencement Visits<\/li>\n
    • \u2022 Monitoring<\/li>\n
    • \u2022 Results reports<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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      \ud83e\udd1d Collaborative Model<\/h3>\n

      \ud83d\udd04 Flexible Team Structure:<\/strong><\/p>\n

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      • \u2022 Team-based companies:<\/strong> We manage the processes (control\/cost).<\/li>\n
      • \u2022 Team requirements:<\/strong> We plan the site with our CRO partner.<\/li>\n
      • \u2022 Physician\/Center recommendation:<\/strong> We share clinical leadership.<\/li>\n<\/ul>\n

        \ud83d\udcc1 Deliveries<\/h3>\n

        Protocol, ethics committee files, data collection tools, clinical trial contracts, and final outcome reports (CER\/PMCF integration).<\/p>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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        \u2705 Why Era Management?<\/h3>\n
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        • \u2714 Clinical consulting focused solely on medical devices.<\/li>\n
        • \u2714 ISO 14155’e tam uyumlu s\u00fcre\u00e7 y\u00f6netimi<\/li>\n
        • \u2714 Smart data strategies for \u201clegacy\u201d products<\/li>\n
        • \u2714 Integrated working model with the pharmaceutical CRO partner network.<\/li>\n
        • \u2714 Flexible structure that supports collaboration between physicians and the field.<\/li>\n<\/ul>\n
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          \ud83d\udcde Contact Us!<\/h4>\n

          \ud83d\udc49 Contact us to develop a clinical data strategy or study plan for your product.<\/p>\n<\/div>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>

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          \"\"<\/div>\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"

          T\u0131bbi cihazlar\u0131n\u0131z\u0131n g\u00fcvenli\u011fini ve performans\u0131n\u0131 bilimsel kan\u0131tlarla desteklemek amac\u0131yla, g\u00fcncel etik ve yasal kurallara tam uyumlu klinik veri toplama ve literat\u00fcr analiz s\u00fcre\u00e7leri y\u00fcr\u00fct\u00fcyoruz.<\/p>","protected":false},"featured_media":4528,"menu_order":0,"template":"","class_list":["post-4185","event","type-event","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event\/4185","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event"}],"about":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/types\/event"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media\/4528"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=4185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}