{"id":202,"date":"2020-01-13T09:44:55","date_gmt":"2020-01-13T09:44:55","guid":{"rendered":"https:\/\/jupiterx.artbees.net\/conference-2\/?page_id=202"},"modified":"2025-10-27T16:02:32","modified_gmt":"2025-10-27T15:02:32","slug":"compliance","status":"publish","type":"page","link":"https:\/\/www.clinsearch.net\/fr\/compliance\/","title":{"rendered":"Engagement"},"content":{"rendered":"
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Politique\u00a0<\/span>qualit\u00e9<\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Politique de qualit\u00e9<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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ClinSearch s\u2019engage \u00e0 fournir des services de haute qualit\u00e9 \u00e0 ses clients.\nPour cela, nous maintenons un Syst\u00e8me Qualit\u00e9 rigoureusement d\u00e9fini, orient\u00e9 selon les standards internationaux.
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Nos normes sont bas\u00e9es sur\u00a0:<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Guide AHWP
\nCONSORT
\nECoP
\nEU GDPR
\nFDA CFR 21 part 11
\nGCDMP
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ICH \u2014 E6
\nICH \u2014 E9
\nISO 13485
\nISO 14155
\nISO 14971
\nISO 19011
\nISO 27001<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 27701
\nHDS 1-6
\nISO 9001
\nExigences l\u00e9gales et r\u00e9glementaires
\nMEDDEV
\nSTROBE<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Engagement <\/span>conformit\u00e9<\/span><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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ClinSearch est r\u00e9solument engag\u00e9 \u00e0 op\u00e9rer de mani\u00e8re \u00e9thique et conforme, dans l\u2019int\u00e9r\u00eat de ses clients. \u00c0 ce titre, nous menons nos prestations en conformit\u00e9 avec la l\u00e9gislation, notamment le \n\nForeign Corrupt Practices Act am\u00e9ricain de 1977<\/b><\/a>, tel que modifi\u00e9, 15 U.S.C. \u00a7\u00a7 78dd-1, et seq. (FCPA) et le \n\nUK Bribery Act 2010 <\/b><\/a>\n\nainsi qu\u2019avec les principes \u00e9dict\u00e9s par Advamed, Eucomed et EDMA dans leurs \n\n\ncodes \n<\/b><\/a>\n\n\u00e9thiques\n<\/b><\/a>\n\nrespectifs.\n<\/b><\/a>\n\n\n Nous respectons \u00e9galement les principes communs ratifi\u00e9s en mai 2011 par neuf associations professionnelles du secteur des technologies m\u00e9dicales (D\u00e9claration mondiale sur les interactions \u00e9thiques entre les entreprises de technologies m\u00e9dicales et les professionnels de sant\u00e9).

Ce document a \u00e9t\u00e9 sign\u00e9 pour la premi\u00e8re fois en mai 2010 par Advamed, Eucomed et EDMA (D\u00e9claration transatlantique conjointe sur les interactions \u00e9thiques entre les entreprises de technologies m\u00e9dicales et les professionnels de sant\u00e9).

Outre ces documents, une politique de tol\u00e9rance z\u00e9ro d\u00e9coule \u00e0 la fois de la FCPA, qui a d\u00e9j\u00e0 g\u00e9n\u00e9r\u00e9 des milliards de dollars de p\u00e9nalit\u00e9s, et du UK Bribery Act 2010, qui est entr\u00e9 en vigueur le 1er juillet 2011.

Lorsque l'industrie s'adresse aux professionnels de la sant\u00e9, il existe un risque syst\u00e9mique de d\u00e9velopper des relations biais\u00e9es. Toutefois, la relation entre l'industrie et les professionnels de la sant\u00e9 est n\u00e9cessaire et l\u00e9gitime dans deux situations qui conduisent \u00e0 l'am\u00e9lioration de la science et des connaissances m\u00e9dicales : l'\u00e9valuation des produits de sant\u00e9 et la formation et l'\u00e9ducation des professionnels de la sant\u00e9. Par cons\u00e9quent, les \u00e9valuations cliniques, qui ne peuvent avoir lieu sans l'implication des professionnels de la sant\u00e9, apparaissent comme un sujet majeur o\u00f9 les principes \u00e9thiques et anti-corruption doivent \u00eatre appliqu\u00e9s.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Les \u00e9valuations cliniques sont le seul moyen de prouver l'innovation de votre produit : non seulement pour obtenir la conformit\u00e9 CE, mais aussi pour recueillir les preuves cliniques qui sont d\u00e9sormais n\u00e9cessaires pour constituer un dossier solide en vue des strat\u00e9gies de tarification et de remboursement.

ClinSearch propose des solutions pour les \u00e9valuations cliniques qui r\u00e9pondent aux principes de conformit\u00e9 de l'organigramme cit\u00e9 ci-dessus. Nous sommes extr\u00eamement vigilants en ce qui concerne les r\u00e8gles de r\u00e9daction des contrats financiers : les accords financiers doivent \u00eatre appropri\u00e9s, justes et transparents. Le contrat est sign\u00e9 avant le d\u00e9but de la recherche et le paiement n'est effectu\u00e9 que lorsque les professionnels de sant\u00e9 ont effectu\u00e9 un travail de qualit\u00e9. En outre, les professionnels de la sant\u00e9 s'engagent \u00e0 d\u00e9clarer un conflit d'int\u00e9r\u00eats lorsqu'ils participent \u00e0 des publications scientifiques en rapport avec la recherche clinique.

Enfin, nous pensons que la conformit\u00e9 peut \u00eatre garantie si les diff\u00e9rentes responsabilit\u00e9s sont bien r\u00e9parties entre les parties prenantes de l'\u00e9valuation clinique. Ainsi, pour nos projets d'\u00e9valuation clinique, ClinSearch fait appel \u00e0 des ressources internes ainsi qu'\u00e0 des professionnels de sant\u00e9 ind\u00e9pendants et qualifi\u00e9s.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Quality\u00a0documents Quality policy ClinSearch is committed to providing high quality services to its clients. Therefore, we maintain a well-defined Quality System orientated towards international quality standards. Our standards are based on: AHWP guidance CONSORT ECoP EU GDPR FDA CFR 21 part 11 GCDMP GEP ICH \u2014 E6 ICH \u2014 E9 ISO 13485 ISO 14155 ISO […]<\/p>","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-202","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nCompliance - ClinSearch<\/title>\n<meta name=\"description\" content=\"Events and conferences need to be promoted in the most eye-catching way. 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