{"id":2348,"date":"2017-11-07T01:26:28","date_gmt":"2017-11-07T06:26:28","guid":{"rendered":"https:\/\/colpittsclinical.com\/?p=2348"},"modified":"2022-08-25T01:06:51","modified_gmt":"2022-08-25T05:06:51","slug":"outsourcing-clinical-trials-to-cros-a-trend-or-here-to-stay","status":"publish","type":"post","link":"https:\/\/colpittsclinical.com\/cs\/outsourcing-clinical-trials-to-cros-a-trend-or-here-to-stay\/","title":{"rendered":"Outsourcing klinick\u00fdch studi\u00ed u CRO: Trend, nebo to z\u016fstane?"},"content":{"rendered":"<p>Mnohdy pojem \u201coutsourcing\u201d vyvol\u00e1v\u00e1 negativn\u00ed reakce, ale na konferenci Fierce Biotech 2017, kter\u00e1 se letos konala v Bostonu, byl outsourcing hlavn\u00edm t\u00e9matem pozitivn\u00edch rozhovor\u016f. Jedn\u00edm z hlavn\u00edch poznatk\u016f bylo, \u017ee pokud je to provedeno promy\u0161len\u011b, m\u016f\u017ee zadavatelsk\u00e1 spole\u010dnost, kter\u00e1 zad\u00e1v\u00e1 klinick\u00e1 hodnocen\u00ed CRO, z\u00edskat v\u00fdhodn\u00fd p\u0159\u00edstup k terapeutick\u00fdm a klinick\u00fdm odborn\u00fdm znalostem. V podstat\u011b v\u0161ichni maj\u00ed prosp\u011bch z toho, \u017ee u stolu sed\u00ed ti nejznalej\u0161\u00ed lid\u00e9, zejm\u00e9na pacienti.<\/p>\n<p>V jedn\u00e9 z konferen\u010dn\u00edch prezentac\u00ed, kterou p\u0159ednesla Karen Gardnerov\u00e1, vrchn\u00ed \u0159editelka klinick\u00e9ho v\u00fdvoje spole\u010dnosti Seqirus, bylo uvedeno n\u011bkolik kl\u00ed\u010dov\u00fdch krit\u00e9ri\u00ed v\u00fdb\u011bru, na kter\u00e1 je t\u0159eba se zam\u011b\u0159it p\u0159i hled\u00e1n\u00ed nov\u00e9ho CRO: kvalita, zku\u0161enosti, schopnosti, vztahy, historie regula\u010dn\u00edch kontrol, n\u00e1klady, velikost CRO, geografick\u00e1 poloha, pov\u011bst, p\u0159edchoz\u00ed spolupr\u00e1ce a specifick\u00e9 siln\u00e9 str\u00e1nky poskytovatel\u016f v jednotliv\u00fdch oblastech.<\/p>\n<p>Podle \u010dasopisu American Pharmaceutical Review \u201crostouc\u00ed n\u00e1klady a klesaj\u00edc\u00ed produktivita vedou pr\u016fmyslov\u00e9 spole\u010dnosti k tomu, \u017ee st\u00e1le v\u00edce funkc\u00ed zad\u00e1vaj\u00ed CRO, aby dos\u00e1hly \u00faspory n\u00e1klad\u016f. Krom\u011b toho, \u017ee CRO poskytuj\u00ed v\u00fdvoj\u00e1\u0159\u016fm l\u00e9k\u016f zna\u010dn\u00e9 glob\u00e1ln\u00ed kapacity, staly se rozhoduj\u00edc\u00edm p\u0159isp\u011bvatelem do program\u016f klinick\u00fdch hodnocen\u00ed. Podle zpr\u00e1vy spole\u010dnosti Research and Markets z roku 2016 jsou klinick\u00e9 studie prov\u00e1d\u011bn\u00e9 CRO dokon\u010deny a\u017e o 30% rychleji ne\u017e ty, kter\u00e9 farmaceutick\u00e9 spole\u010dnosti prov\u00e1d\u011bj\u00ed intern\u011b. To se samoz\u0159ejm\u011b prom\u00edt\u00e1 do zna\u010dn\u00e9 \u00faspory n\u00e1klad\u016f a pravd\u011bpodobn\u011b i do rychlej\u0161\u00edho uveden\u00ed na trh.\u201d<\/p>\n<p>Spr\u00e1vn\u00fd CRO pro va\u0161i studii v\u00e1m tak\u00e9 poskytne p\u0159\u00edstup k odborn\u00edk\u016fm z oboru s rozs\u00e1hl\u00fdmi znalostmi p\u0159i v\u00fdb\u011bru nejlep\u0161\u00edch glob\u00e1ln\u00edch pracovi\u0161\u0165 v r\u00e1mci po\u017eadavk\u016f stanoven\u00fdch sponzorskou spole\u010dnost\u00ed. Mo\u017en\u00e1 tedy outsourcing v\u016fbec nen\u00ed trendem, ale sp\u00ed\u0161e osv\u011bd\u010den\u00fdm postupem.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Many times the term \u201coutsourcing\u201d invokes a negative response, but at the Fierce Biotech 2017 conference hosted this year in Boston, outsourcing was a key topic of positive conversations. One of the main takeaways was that when it\u2019s done thoughtfully, a sponsor company outsourcing clinical trials to CROs can provide beneficial access to therapeutic and [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":2350,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[6],"tags":[],"class_list":["post-2348","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-trials"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Outsourcing Clinical Trials to CROs: A Trend or Here to Stay? - Colpitts Clinical<\/title>\n<meta name=\"description\" content=\"A 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