{"id":6045,"date":"2021-09-24T09:12:06","date_gmt":"2021-09-24T06:12:06","guid":{"rendered":"https:\/\/medfilesgroup.com\/palvelut\/kliiniset-tutkimuspalvelut\/tutkimuksen-valmistelu\/medical-writing\/"},"modified":"2023-09-07T12:39:25","modified_gmt":"2023-09-07T09:39:25","slug":"laaketieteellinen-kirjoittaminen","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/fi\/palvelut\/kliiniset-tutkimuspalvelut\/laaketieteellinen-kirjoittaminen\/","title":{"rendered":"L\u00e4\u00e4ketieteellinen kirjoittaminen"},"content":{"rendered":"\n<figure class=\"wp-block-image alignfull size-full\"><img width=\"1920\" height=\"554\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/medical-writing.jpg\" alt=\"Medical writing\" class=\"wp-image-13210\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/medical-writing.jpg 1920w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/medical-writing-300x87.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/medical-writing-1024x295.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/medical-writing-768x222.jpg 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/medical-writing-1536x443.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<div class=\"wp-block-group alignfull\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n\n\n\n<h1 class=\"wp-block-heading\" style=\"font-size:33px\">L\u00e4\u00e4ketieteellinen kirjoittaminen<\/h1>\n\n\n\n<p>Tohtoritason asiantuntemuksensa ja erinomaisten viestint\u00e4taitonsa avulla Medfilesin l\u00e4\u00e4ketieteellisen kirjoittamisen ammattilaiset tuottavat laadukkaita dokumentteja vaatimusten ja toiveidesi mukaisesti.<\/p>\n\n\n\n<p>Tiimimme hoitaa kirjoitust\u00f6iden kaikki valmistelut ja hallinnoinnin tai tukee tiimi\u00e4si jo meneill\u00e4\u00e4n olevassa projektissa. Kirjoittajatiimimme voi auttaa tuotteesi elinkaaren miss\u00e4 tahansa vaiheessa: voimme huolehtia koko kehitysty\u00f6st\u00e4 ja hakemuksen j\u00e4tt\u00e4misest\u00e4 tai arvioida ja laatia yksitt\u00e4isi\u00e4 asiakirjoja.<\/p>\n\n\n\n<p><strong>Kokeneet kirjoittajamme auttavat kaikissa viranomaisasiakirjoissa:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Faasien I-IV tutkimussuunnitelmat ja niiden muutokset<\/li>\n\n\n\n<li>Kliinisten tutkimusten raportit (faasit I-IV)<\/li>\n\n\n\n<li>Kliiniset tutkimussuunnitelmat (CIP), suorituskykytutkimusten suunnitelmat (CPSP) ja vastaavat l\u00e4\u00e4kinn\u00e4llisi\u00e4 laitteita koskevat raportit<\/li>\n\n\n\n<li>Kliinisten terveysv\u00e4itteiden todentamistutkimusten suunnitelmat ja raportit<\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laakinnalliset-laitteet-ja-ivd-laitteet\/\">L\u00e4\u00e4kinn\u00e4llisten laitteiden kliinisen arvioinnin suunnitelmat (CEP) ja raportit (CERs)<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laaketurvapalvelut-ihmis-ja-elainlaakkeille\/\">M\u00e4\u00e4r\u00e4aikaiset turvallisuuskatsaukset (Periodic Safety Update Report, PSUR) ja l\u00e4\u00e4ketutkimusten vuosittaiset turvallisuusraportit (Development Periodic Update Report, DSUR)<\/a><\/li>\n\n\n\n<li>Haittavaikutusilmoitusten (ICSR) kirjoittaminen<\/li>\n\n\n\n<li>Kliiniset katsaukset ja yhteenvedot<\/li>\n<\/ul>\n\n\n\n<div style=\"height:24px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-background\" style=\"background-color:#f3f3f3\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\">L\u00e4\u00e4ketieteellinen ja regulatiivinen kirjoittaminen<\/h2>\n\n\n\n<div style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:18px\"><strong>1. KLIININEN VAIHE<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>L\u00e4\u00e4kinn\u00e4llisten laitteiden kliinisten tutkimusten suunnitelmat<\/li>\n\n\n\n<li>Kliinisten l\u00e4\u00e4ketutkimuksen ja elintarvikeinterventioiden tutkimussuunnitelmat<\/li>\n\n\n\n<li>Tutkijan tietopaketit<\/li>\n\n\n\n<li>Tutkimusl\u00e4\u00e4kett\u00e4 koskevat tiedot (IMPD) \u2013 CMC-osa<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:18px\"><strong>2. MYYNTILUPAVAIHE<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Kliiniset ja ei-kliiniset yhteenvedot ja katsaukset myyntilupaa varten<\/li>\n\n\n\n<li>Kliiniset arviointiraportit<\/li>\n\n\n\n<li>Biowaiver-hakemuksen perustelut<\/li>\n\n\n\n<li>Ymp\u00e4rist\u00f6riskinarviointi vaiheessa I (ERAs)<\/li>\n\n\n\n<li>L\u00e4\u00e4kinn\u00e4llisten laitteiden kliininen ja biologinen arviointi<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:18px\"><strong>3. YLL\u00c4PITO<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>M\u00e4\u00e4r\u00e4aikaiset turvallisuuskatsaukset (PSUR) ja riskienminimointisuunnitelmat (RMS)<\/li>\n\n\n\n<li>Tiivistelmien ja julkaisujen k\u00e4sikirjoitukset<\/li>\n\n\n\n<li>Tiedostojen tekninen yll\u00e4pito<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:36px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Medfilesin laatii tarkat ja selke\u00e4t tekstit toiveidesi mukaisesti. Katso my\u00f6s:<\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/kliiniset-tutkimuspalvelut\/\">Kliiniset tutkimuspalvelut<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/myyntilupapalvelut\/\">Myyntilupapalvelut<\/a><\/div>\n\n\n\n<div class=\"wp-block-button has-custom-font-size\" style=\"font-size:15px\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laaketurvapalvelut-ihmis-ja-elainlaakkeille\/\">L\u00e4\u00e4keturvapalvelut<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:36px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-white-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-wide\" style=\"background-color:#ecececc2;color:#ecececc2\"\/>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" id=\"contact-us\">Kerron mielell\u00e4ni lis\u00e4\u00e4<\/h2>\n\n\n\n<div style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:200px\"><div class=\"wp-block-image is-style-default\">\n<figure class=\"alignleft size-full\"><img width=\"600\" height=\"900\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/essi-sarkkinen.jpg\" alt=\"Essi Sarkkinen\" class=\"wp-image-13727\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/essi-sarkkinen.jpg 600w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/essi-sarkkinen-200x300.jpg 200w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:360px\">\n<p class=\"has-text-align-left\"><strong>Essi Sarkkinen<\/strong><br>Director, Business Development &amp; Clinical Research<br>+358 20 744 1520<br><a href=\"mailto:mervi.reini@medfiles.eu\">essi.sarkkinen@medfiles.eu<\/a><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-default\" style=\"background-color:#ecececc2;color:#ecececc2\"\/>\n<\/div><\/div>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-be00b838\">\n<div class=\"gb-grid-column gb-grid-column-453c546f\"><div class=\"gb-container gb-container-453c546f contact-us\"><div class=\"gb-inside-container\">\n<script>\nvar gform;gform||(document.addEventListener(\"gform_main_scripts_loaded\",function(){gform.scriptsLoaded=!0}),document.addEventListener(\"gform\/theme\/scripts_loaded\",function(){gform.themeScriptsLoaded=!0}),window.addEventListener(\"DOMContentLoaded\",function(){gform.domLoaded=!0}),gform={domLoaded:!1,scriptsLoaded:!1,themeScriptsLoaded:!1,isFormEditor:()=>\"function\"==typeof 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data-form-theme='gravity-theme' data-form-index='0' id='gform_wrapper_5' >\n                        <div class='gform_heading'>\n                            <h2 class=\"gform_title\">Ota yhteytt\u00e4<\/h2>\n                            <p class='gform_description'><\/p>\n                        <\/div><form method='post' enctype='multipart\/form-data'  id='gform_5'  action='\/fi\/wp-json\/wp\/v2\/pages\/6045' data-formid='5' novalidate>\n                        <div class='gform-body gform_body'><div id='gform_fields_5' class='gform_fields top_label form_sublabel_below description_below validation_below'><div id=\"field_5_2\" class=\"gfield gfield--type-text gfield--input-type-text gfield--width-full gfield_contains_required field_sublabel_below gfield--no-description field_description_below field_validation_below gfield_visibility_visible\"  ><label class='gfield_label gform-field-label' for='input_5_2'><span class='gform-field-label__text'>Nimi<\/span><span 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name='gform_source_page_number_5' id='gform_source_page_number_5' value='1' \/>\n            <input type='hidden' name='gform_field_values' value='' \/>\n            \n        <\/div>\n                        <\/form>\n                        <\/div>\n<\/div><\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-41ade907\"><div class=\"gb-container gb-container-41ade907 news-and-events\"><div class=\"gb-inside-container\">\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:28px\">Sinua voisi kiinnostaa: <\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/kliiniset-tutkimuspalvelut\/\">Kliiniset tutkimuspalvelut<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/myyntilupapalvelut\/\">Myyntilupapalvelut<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/laaketurvapalvelut-ihmis-ja-elainlaakkeille\/\">L\u00e4\u00e4keturvapalvelut<\/a><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/yhteystiedot\/tilaa-medfilesin-uutiskirje\/\">Tilaa Medfilesin uutiskirje<\/a><\/div>\n<\/div>\n\n<\/div><\/div><\/div>\n<\/div>\n\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>L\u00e4\u00e4ketieteellinen kirjoittaminen Tohtoritason asiantuntemuksensa ja erinomaisten viestint\u00e4taitonsa avulla Medfilesin l\u00e4\u00e4ketieteellisen kirjoittamisen ammattilaiset tuottavat laadukkaita dokumentteja vaatimusten ja toiveidesi mukaisesti. Tiimimme hoitaa kirjoitust\u00f6iden kaikki valmistelut ja &#8230; <a title=\"L\u00e4\u00e4ketieteellinen kirjoittaminen\" class=\"read-more\" href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/kliiniset-tutkimuspalvelut\/laaketieteellinen-kirjoittaminen\/\" aria-label=\"Lis\u00e4\u00e4 L\u00e4\u00e4ketieteellinen kirjoittaminen\">Lue lis\u00e4\u00e4<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":6014,"menu_order":41,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6045","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/6045","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/comments?post=6045"}],"version-history":[{"count":10,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/6045\/revisions"}],"predecessor-version":[{"id":14051,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/6045\/revisions\/14051"}],"up":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/pages\/6014"}],"wp:attachment":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/media?parent=6045"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}