KLINICK\u00c9 TESTOV\u00c1N\u00cd<\/h3><\/span><\/div><\/div><\/div>Na\u0161e klinick\u00e9 odd\u011blen\u00ed funguje ji\u017e od roku 2007 a m\u00e1 za sebou v\u00edce ne\u017e ne\u017e 300 BA\/BE\/PK dokon\u010den\u00fdch studi\u00ed.
\nJsme vybaveni vlastn\u00edmi klinick\u00fdmi jednotkami s souhrnou kapacitou 96 l\u016f\u017eek, ve kter\u00fdch prov\u00e1d\u00edme kompletn\u00ed klinick\u00e9 testov\u00e1n\u00ed od n\u00e1vrhu designu studie a\u017e po farmakokinetick\u00e9 a statistick\u00e9 vyhodnocen\u00ed.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
- P\u0159ehled<\/div><\/a><\/li>
- BE studie \/ Studie I. f\u00e1ze<\/div><\/a><\/li>
- Typy studi\u00ed<\/div><\/a><\/li>
- Speci\u00e1ln\u00ed populace subjekt\u016f<\/div><\/a><\/li>
- Design studi\u00ed<\/div><\/a><\/li>
- QA & QC<\/div><\/a><\/li><\/ul><\/div>
- P\u0159ehled<\/div><\/a><\/li><\/ul><\/div>\n
P\u0159ehled<\/h2>\n
Poskytujeme komplexn\u00ed slu\u017eby v oblasti klinick\u00e9ho hodnocen\u00ed (F\u00e1ze I). Klinick\u00e9 hodnocen\u00ed zahrnuje vlastn\u00ed proveden\u00ed klinick\u00e9 \u010d\u00e1sti studie, na kter\u00e9 navazuje bioanalytick\u00e9, farmakokinetick\u00e9 a statistick\u00e9 vyhodnocen\u00ed. Na\u0161\u00ed specializac\u00ed jsou bioekvivalen\u010dn\u00ed studie (BE), ale jsme samoz\u0159ejm\u011b schopni prov\u00e9st nejr\u016fzn\u011bj\u0161\u00ed typy farmakokinetick\u00fdch \u010di farmakodynamick\u00fdch studi\u00ed, dle po\u017eadavk\u016f klienta.<\/p>\n
K prov\u00e1d\u011bn\u00ed klinick\u00fdch studi\u00ed slou\u017e\u00ed pln\u011b vybaven\u00e9 l\u016f\u017ekov\u00e9 za\u0159\u00edzen\u00ed, kde je subjekt\u016fm studie v\u011bnov\u00e1na ve\u0161ker\u00e1 nezbytn\u00e1 p\u00e9\u010de a pohodl\u00ed. Na \u010dinnost klinick\u00e9ho odd\u011blen\u00ed bezprost\u0159edn\u011b navazuje Bioanalytick\u00e9 odd\u011blen\u00ed, jeho\u017e laborato\u0159e jsou vybaveny \u0161pi\u010dkov\u00fdmi p\u0159\u00edstroji, zejm\u00e9na \u0159adou HPLC\/MS\/MS za\u0159\u00edzen\u00edmi za pomoci kter\u00fdch je mo\u017en\u00e9 prov\u00e1d\u011bt stanoven\u00ed nejen \u00fa\u010dinn\u00fdch l\u00e1tek, ale i metabolit\u016f v r\u016fzn\u00fdch biologick\u00fdch matric\u00edch. Nam\u011b\u0159en\u00e1 analytick\u00e1 data jsou d\u00e1le zpracov\u00e1v\u00e1na skupinou odborn\u00edk\u016f pro farmakokinetick\u00e9 a statistick\u00e9 vyhodnocen\u00ed. Uveden\u00e1 pracovi\u0161t\u011b jsou schopna zajistit komplexn\u00ed servis od n\u00e1vrhu studie, p\u0159es zaji\u0161t\u011bn\u00ed povolen\u00ed Etickou komis\u00ed a St\u00e1tn\u00edm \u00fastavem pro kontrolu l\u00e9\u010div, jej\u00ed vlastn\u00ed proveden\u00ed a\u017e po vypracov\u00e1n\u00ed z\u00e1v\u011bre\u010dn\u00e9 zpr\u00e1vy dle standardn\u00edch sv\u011btov\u00fdch po\u017eadavk\u016f. Ve\u0161ker\u00e9 \u010dinnosti prob\u00edhaj\u00ed v t\u011bsn\u00e9 spolupr\u00e1ci se zadavatelem studie a jsou prov\u00e1d\u011bny v syst\u00e9mu Spr\u00e1vn\u00e9 klinick\u00e9 praxe (SKP) nebo Spr\u00e1vn\u00e9 laboratorn\u00ed praxe (SLP) pod dohledem Jednotky ji\u0161t\u011bn\u00ed jakosti (QAU).<\/p>\n<\/div>
- BE studie \/ Studie I. f\u00e1ze<\/div><\/a><\/li><\/ul><\/div>\n
BE studie \/ Studie I. f\u00e1ze<\/h2>\n
Spole\u010dnost m\u00e1 dlouhodob\u00e9 zku\u0161enosti s prov\u00e1d\u011bn\u00edm farmakokinetick\u00fdch \/ bioekvivalen\u010dn\u00edch studi\u00ed. T\u00fdm zku\u0161en\u00fdch odborn\u00edk\u016f zajist\u00ed kompletn\u00ed proveden\u00ed studi\u00ed na zdrav\u00fdch dobrovoln\u00edc\u00edch, na \u00a0zvl\u00e1\u0161tn\u00ed popula\u010dn\u00ed skupin\u011b t\u011bchto dobrovoln\u00edk\u016f anebo na populaci se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami. Jedn\u00e1 se o tyto \u010dinnosti:<\/p>\n
Klinick\u00e1 \u010d\u00e1st<\/strong><\/p>\n\n- konzulta\u010dn\u00ed \u010dinnost p\u0159i n\u00e1vrhu studie<\/li>\n
- vypracov\u00e1n\u00ed protokolu studie<\/li>\n
- ur\u010den\u00ed velikosti souboru a randomizace<\/li>\n
- n\u00e1vrh a vypracov\u00e1n\u00ed z\u00e1znam\u016f subjekt\u016f hodnocen\u00ed (CRF)<\/li>\n
- p\u0159\u00edprava informovan\u00e9ho souhlasu<\/li>\n
- p\u0159\u00edprava a administrace dokumentace pro nez\u00e1vislou etickou komisi<\/li>\n
- p\u0159\u00edprava a administrace dokumentace regula\u010dn\u00edmu \u00fa\u0159adu (St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div)<\/li>\n
- n\u00e1bor subjekt\u016f studie, p\u0159\u00edpadn\u011b zvl\u00e1\u0161tn\u00ed populace dle po\u017eadavk\u016f zadavatele<\/li>\n
- vstupn\u00ed a v\u00fdstupn\u00ed vy\u0161et\u0159en\u00ed v\u010detn\u011b nezbytn\u00fdch laboratorn\u00edch klinick\u00fdch test\u016f<\/li>\n
- proveden\u00ed studie v\u010detn\u011b odb\u011br\u016f krve a klinick\u00fdch vy\u0161et\u0159en\u00ed<\/li>\n
- vyhodnocen\u00ed a hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edch p\u0159\u00edhod<\/li>\n
- zpracov\u00e1n\u00ed klinick\u00fdch \u00fadaj\u016f a statistika<\/li>\n<\/ul>\n
Bioanalytick\u00e1 \u010d\u00e1st<\/strong><\/p>\n\n- v\u00fdvoj a validace metod ke stanoven\u00ed l\u00e9\u010div a metabolit\u016f<\/li>\n
- anal\u00fdza l\u00e9\u010div v biologick\u00fdch matric\u00edch<\/li>\n<\/ul>\n
Vyhodnocen\u00ed<\/strong><\/p>\n\n- zpracov\u00e1n\u00ed bioanalytick\u00fdch a farmakokinetick\u00e9 vyhodnocen\u00ed<\/li>\n
- biostatistika (za vyu\u017eit\u00ed SAS programu)<\/li>\n
- vypracov\u00e1n\u00ed zpr\u00e1vy o proveden\u00ed studie<\/li>\n
- archivov\u00e1n\u00ed dokumentace<\/li>\n<\/ul>\n
QA \/ QC<\/strong><\/p>\n\n- zaji\u0161t\u011bn\u00ed a kontrola jakosti ve v\u0161ech etap\u00e1ch studie<\/li>\n<\/ul>\n<\/div>
- Typy studi\u00ed<\/div><\/a><\/li><\/ul><\/div>\n
Typy studi\u00ed<\/h2>\n
Dle po\u017eadavk\u016f zadavatele prov\u00e1d\u00edme studie \u00a0r\u016fzn\u00e9ho designu v\u010detn\u011b statistick\u00e9ho vyhodnocen\u00ed nap\u0159:<\/p>\n
\n- Farmakokinetick\u00e9 studie<\/li>\n
- Toxikokinetick\u00e9 studie (zv\u00ed\u0159ata)<\/li>\n
- Farmakodynamick\u00e9 studie v\u010detn\u011b hodnocen\u00ed klinick\u00fdch parametr\u016f<\/li>\n
- Biologick\u00e1 dostupnost<\/li>\n
- Bioekvivalen\u010dn\u00ed studie<\/li>\n
- D\u00e1vkov\u00e1 linearita<\/li>\n
- R\u016fzn\u00e9 zp\u016fsoby pod\u00e1n\u00ed \/ r\u016fzn\u00e9 l\u00e9kov\u00e9 formy<\/li>\n
- Steady-state studies<\/li>\n
- In vitro in vivo korelace<\/li>\n
- Interakce l\u00e9\u010div, potravin nebo alkoholu<\/li>\n
- Vliv stravy (nala\u010dno \/ po pod\u00e1n\u00ed stravy)<\/li>\n
- Vliv v\u011bku \/ pohlav\u00ed<\/li>\n
- Studie na speci\u00e1ln\u00ed populaci<\/li>\n
- Ethno-bridging studies<\/li>\n
- Studie na populaci se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami<\/li>\n<\/ul>\n<\/div>
- Speci\u00e1ln\u00ed populace subjekt\u016f<\/div><\/a><\/li><\/ul><\/div>\n
Speci\u00e1ln\u00ed populace subjekt\u016f<\/h2>\n
Quinta-Analytica s.r.o. m\u00e1 k dispozici rozs\u00e1hlou datab\u00e1zi (pool) aktivn\u00edch zdrav\u00fdch dobrovoln\u00edk\u016f a zajist\u00ed dle po\u017eadavk\u016f zadavatele tak\u00e9 speci\u00e1ln\u00ed populace dobrovoln\u00edk\u016f anebo populace subjekt\u016f se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami. Pro pot\u0159eby zaji\u0161t\u011bn\u00ed dob\u0159e definovan\u00e9 skupiny subjekt\u016f pro I.-IIa. f\u00e1ze \u00fazce spolupracujeme se soci\u00e1ln\u00edmi nebo zdravotn\u00edmi za\u0159\u00edzen\u00edmi. Tito subjekty slou\u017e\u00ed k proveden\u00ed bioekvivalen\u010dn\u00edch\/farmakokinetick\u00fdch studi\u00ed nebo studi\u00ed I-IIa f\u00e1ze. Zajist\u00edme se spolupr\u00e1ci proveden\u00ed toxikokinetick\u00fdch anebo dal\u0161\u00edch farmakokinetick\u00fdch studi\u00ed na zv\u00ed\u0159atech. Jedn\u00e1 se o tyto c\u00edlov\u00e9 skupiny:<\/p>\n
\n- preklinick\u00e1 \u010d\u00e1st \u2013ve spolupr\u00e1ci zaji\u0161t\u011bn\u00ed studie na zv\u00ed\u0159atech (toxikokinetika, farmakokinetika)<\/li>\n
- zdrav\u00ed mu\u017ei a \u017eeny<\/li>\n
- speci\u00e1ln\u00ed populace:<\/li>\n<\/ul>\n
\n- \n
\n- sta\u0159\u00ed mu\u017ei a \u017eeny (> 65 let)<\/li>\n
- postmenopauz\u00e1ln\u00ed \u017eeny<\/li>\n
- subjekty s nadv\u00e1hou \/ ob\u00e9zn\u00ed<\/li>\n
- subjekty asijsk\u00e9ho p\u016fvodu<\/li>\n
- rychl\u00ed \/ pomal\u00ed metaboliz\u00e9\u0159i<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
\n- populace se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami:\n
\n- subjekty s po\u0161kozen\u00edm ledvin<\/li>\n
- subjekty s po\u0161kozen\u00edm jater<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>
- Design studi\u00ed<\/div><\/a><\/li><\/ul><\/div>\n
Design studi\u00ed<\/h2>\n
Zajist\u00edme studie s r\u016fzn\u00fdm designem dle po\u017eadavk\u016f zadavatele v\u010detn\u011b konzultac\u00ed. Jedn\u00e1 se nap\u0159. o tyto studie:<\/p>\n
\n- Jedna nebo v\u00edce periodick\u00e9 studie<\/li>\n
- Paraleln\u00ed, s\u00e9riov\u00fd nebo crossover design<\/li>\n
- Otev\u0159en\u00e9 (nezaslepen\u00e9) studie<\/li>\n
- Zaslepen\u00e9 \u010di dvojit\u011b zaslepen\u00e9 studie<\/li>\n
- Ambulantn\u00ed nebo hospitaliza\u010dn\u00ed<\/li>\n
- Pilotn\u00ed a pivot\u00e1ln\u00ed studie<\/li>\n<\/ul>\n<\/div>
- QA & QC<\/div><\/a><\/li><\/ul><\/div>\n
QA & QC<\/h2>\n
Ka\u017ed\u00e1 studie prob\u00edh\u00e1 v souladu se standardy Spr\u00e1vn\u00e9 klinick\u00e9 praxe (SKP) a Spr\u00e1vn\u00e9 laboratorn\u00ed praxe (SLP). Jednotka ji\u0161t\u011bn\u00ed a kontroly kvality (QAU) dle vnit\u0159n\u00edch p\u0159edpis\u016f sleduje dodr\u017eov\u00e1n\u00ed ka\u017ed\u00e9ho kroku od pl\u00e1nov\u00e1n\u00ed (protokol studie), p\u0159es pod\u00e1n\u00ed na Etickou komisi a St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div, proveden\u00ed vlastn\u00ed studie a jej\u00ed zdokumentov\u00e1n\u00ed a\u017e po naps\u00e1n\u00ed z\u00e1v\u011bre\u010dn\u00e9 zpr\u00e1vy. Ve\u0161ker\u00e9 \u010dinnosti prob\u00edhaj\u00ed dle Standardn\u00edch opera\u010dn\u00edch postup\u016f (SOPs) a Protokolu studie.<\/p>\n
\u00dadaje zaznamenan\u00e9 p\u0159i studii, p\u0159enos dat a zpr\u00e1vy proch\u00e1zej\u00ed 100% kontrolou kvality p\u0159ed z\u00e1v\u011bre\u010dn\u00fdm auditem studie jednotkou ji\u0161t\u011bn\u00ed jakosti.<\/p>\n
Pracovn\u00edci QAU zorganizuj\u00ed monitoring studi\u00ed, pokud prob\u00edhaj\u00ed mimo prostory na\u0161eho klinick\u00e9ho za\u0159\u00edzen\u00ed (studie II.-IV f\u00e1ze) a pokud zadavatel na na\u0161e CRO tuto \u010dinnost delegoval. Monitoring studi\u00ed prob\u00edh\u00e1 v souladu s legislativn\u00edmi p\u0159edpisy, po\u017eadavky zadavatele a dle na\u0161ich SOP.<\/p>\n
Pracovn\u00edci QAU mohou na \u017e\u00e1dost druh\u00e9 strany prov\u00e9st nez\u00e1visl\u00fd audit GCP. Audit prob\u00edh\u00e1 na z\u00e1klad\u011b legislativn\u00edch po\u017eadavk\u016f a dle na\u0161ich SOP.<\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div><\/span>Additional Services<\/h2><\/span><\/div><\/div><\/div><\/div><\/div>![](\"https:\/\/www.quinta.cz\/wp-content\/uploads\/2023\/04\/weapons-2.png\" "\\"weapons-2\\"")
<\/span><\/div><\/div><\/div><\/span>NITROSAMINES ANALYSIS<\/h4><\/span><\/div><\/div><\/div>Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.<\/p>\n<\/div>
<\/div><\/div><\/span>More Info <\/i><\/a><\/h1><\/span><\/div><\/div><\/div><\/div><\/div>![](\"https:\/\/www.quinta.cz\/wp-content\/uploads\/2023\/04\/medical.png\" "\\"medical\\"")
<\/span><\/div><\/div><\/div><\/span>MONITORING STUDI\u00cd<\/h4><\/span><\/div><\/div><\/div>Oversight of participant health and correctness of treatments during clinical studies.<\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.quinta.cz\/wp-content\/uploads\/2023\/04\/medical-5.png\" "\\"medical-5\\"")
<\/span><\/div><\/div><\/div><\/span>FARMAKOVIGILANCE<\/h4><\/span><\/div><\/div><\/div>Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.<\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.quinta.cz\/wp-content\/uploads\/2023\/04\/avatar.png\" "\\"avatar\\"")
<\/span><\/div><\/div><\/div><\/span>AUDIT MODULU 3<\/h4><\/span><\/div><\/div><\/div>Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.<\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.quinta.cz\/wp-content\/uploads\/2023\/04\/map-point.png\" "\\"map-point\\"")
<\/span><\/div><\/div><\/div><\/span>KOMPILACE IMPD<\/h4><\/span><\/div><\/div><\/div>As an EU based company we are well-placed to help create & develop your IMPD.<\/p>\n<\/div><\/div><\/div>
Na\u0161e klinick\u00e9 odd\u011blen\u00ed funguje ji\u017e od roku 2007 a m\u00e1 za sebou v\u00edce ne\u017e ne\u017e 300 BA\/BE\/PK dokon\u010den\u00fdch studi\u00ed.
\nJsme vybaveni vlastn\u00edmi klinick\u00fdmi jednotkami s souhrnou kapacitou 96 l\u016f\u017eek, ve kter\u00fdch prov\u00e1d\u00edme kompletn\u00ed klinick\u00e9 testov\u00e1n\u00ed od n\u00e1vrhu designu studie a\u017e po farmakokinetick\u00e9 a statistick\u00e9 vyhodnocen\u00ed.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
- P\u0159ehled<\/div><\/a><\/li>BE studie \/ Studie I. f\u00e1ze<\/div><\/a><\/li>Typy studi\u00ed<\/div><\/a><\/li>Speci\u00e1ln\u00ed populace subjekt\u016f<\/div><\/a><\/li>Design studi\u00ed<\/div><\/a><\/li>QA & QC<\/div><\/a><\/li><\/ul><\/div>
- P\u0159ehled<\/div><\/a><\/li><\/ul><\/div>\n
P\u0159ehled<\/h2>\n
Poskytujeme komplexn\u00ed slu\u017eby v oblasti klinick\u00e9ho hodnocen\u00ed (F\u00e1ze I). Klinick\u00e9 hodnocen\u00ed zahrnuje vlastn\u00ed proveden\u00ed klinick\u00e9 \u010d\u00e1sti studie, na kter\u00e9 navazuje bioanalytick\u00e9, farmakokinetick\u00e9 a statistick\u00e9 vyhodnocen\u00ed. Na\u0161\u00ed specializac\u00ed jsou bioekvivalen\u010dn\u00ed studie (BE), ale jsme samoz\u0159ejm\u011b schopni prov\u00e9st nejr\u016fzn\u011bj\u0161\u00ed typy farmakokinetick\u00fdch \u010di farmakodynamick\u00fdch studi\u00ed, dle po\u017eadavk\u016f klienta.<\/p>\n
K prov\u00e1d\u011bn\u00ed klinick\u00fdch studi\u00ed slou\u017e\u00ed pln\u011b vybaven\u00e9 l\u016f\u017ekov\u00e9 za\u0159\u00edzen\u00ed, kde je subjekt\u016fm studie v\u011bnov\u00e1na ve\u0161ker\u00e1 nezbytn\u00e1 p\u00e9\u010de a pohodl\u00ed. Na \u010dinnost klinick\u00e9ho odd\u011blen\u00ed bezprost\u0159edn\u011b navazuje Bioanalytick\u00e9 odd\u011blen\u00ed, jeho\u017e laborato\u0159e jsou vybaveny \u0161pi\u010dkov\u00fdmi p\u0159\u00edstroji, zejm\u00e9na \u0159adou HPLC\/MS\/MS za\u0159\u00edzen\u00edmi za pomoci kter\u00fdch je mo\u017en\u00e9 prov\u00e1d\u011bt stanoven\u00ed nejen \u00fa\u010dinn\u00fdch l\u00e1tek, ale i metabolit\u016f v r\u016fzn\u00fdch biologick\u00fdch matric\u00edch. Nam\u011b\u0159en\u00e1 analytick\u00e1 data jsou d\u00e1le zpracov\u00e1v\u00e1na skupinou odborn\u00edk\u016f pro farmakokinetick\u00e9 a statistick\u00e9 vyhodnocen\u00ed. Uveden\u00e1 pracovi\u0161t\u011b jsou schopna zajistit komplexn\u00ed servis od n\u00e1vrhu studie, p\u0159es zaji\u0161t\u011bn\u00ed povolen\u00ed Etickou komis\u00ed a St\u00e1tn\u00edm \u00fastavem pro kontrolu l\u00e9\u010div, jej\u00ed vlastn\u00ed proveden\u00ed a\u017e po vypracov\u00e1n\u00ed z\u00e1v\u011bre\u010dn\u00e9 zpr\u00e1vy dle standardn\u00edch sv\u011btov\u00fdch po\u017eadavk\u016f. Ve\u0161ker\u00e9 \u010dinnosti prob\u00edhaj\u00ed v t\u011bsn\u00e9 spolupr\u00e1ci se zadavatelem studie a jsou prov\u00e1d\u011bny v syst\u00e9mu Spr\u00e1vn\u00e9 klinick\u00e9 praxe (SKP) nebo Spr\u00e1vn\u00e9 laboratorn\u00ed praxe (SLP) pod dohledem Jednotky ji\u0161t\u011bn\u00ed jakosti (QAU).<\/p>\n<\/div>
- BE studie \/ Studie I. f\u00e1ze<\/div><\/a><\/li><\/ul><\/div>\n
BE studie \/ Studie I. f\u00e1ze<\/h2>\n
Spole\u010dnost m\u00e1 dlouhodob\u00e9 zku\u0161enosti s prov\u00e1d\u011bn\u00edm farmakokinetick\u00fdch \/ bioekvivalen\u010dn\u00edch studi\u00ed. T\u00fdm zku\u0161en\u00fdch odborn\u00edk\u016f zajist\u00ed kompletn\u00ed proveden\u00ed studi\u00ed na zdrav\u00fdch dobrovoln\u00edc\u00edch, na \u00a0zvl\u00e1\u0161tn\u00ed popula\u010dn\u00ed skupin\u011b t\u011bchto dobrovoln\u00edk\u016f anebo na populaci se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami. Jedn\u00e1 se o tyto \u010dinnosti:<\/p>\n
Klinick\u00e1 \u010d\u00e1st<\/strong><\/p>\n
- \n
- konzulta\u010dn\u00ed \u010dinnost p\u0159i n\u00e1vrhu studie<\/li>\n
- vypracov\u00e1n\u00ed protokolu studie<\/li>\n
- ur\u010den\u00ed velikosti souboru a randomizace<\/li>\n
- n\u00e1vrh a vypracov\u00e1n\u00ed z\u00e1znam\u016f subjekt\u016f hodnocen\u00ed (CRF)<\/li>\n
- p\u0159\u00edprava informovan\u00e9ho souhlasu<\/li>\n
- p\u0159\u00edprava a administrace dokumentace pro nez\u00e1vislou etickou komisi<\/li>\n
- p\u0159\u00edprava a administrace dokumentace regula\u010dn\u00edmu \u00fa\u0159adu (St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div)<\/li>\n
- n\u00e1bor subjekt\u016f studie, p\u0159\u00edpadn\u011b zvl\u00e1\u0161tn\u00ed populace dle po\u017eadavk\u016f zadavatele<\/li>\n
- vstupn\u00ed a v\u00fdstupn\u00ed vy\u0161et\u0159en\u00ed v\u010detn\u011b nezbytn\u00fdch laboratorn\u00edch klinick\u00fdch test\u016f<\/li>\n
- proveden\u00ed studie v\u010detn\u011b odb\u011br\u016f krve a klinick\u00fdch vy\u0161et\u0159en\u00ed<\/li>\n
- vyhodnocen\u00ed a hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edch p\u0159\u00edhod<\/li>\n
- zpracov\u00e1n\u00ed klinick\u00fdch \u00fadaj\u016f a statistika<\/li>\n<\/ul>\n
Bioanalytick\u00e1 \u010d\u00e1st<\/strong><\/p>\n
- \n
- v\u00fdvoj a validace metod ke stanoven\u00ed l\u00e9\u010div a metabolit\u016f<\/li>\n
- anal\u00fdza l\u00e9\u010div v biologick\u00fdch matric\u00edch<\/li>\n<\/ul>\n
Vyhodnocen\u00ed<\/strong><\/p>\n
- \n
- zpracov\u00e1n\u00ed bioanalytick\u00fdch a farmakokinetick\u00e9 vyhodnocen\u00ed<\/li>\n
- biostatistika (za vyu\u017eit\u00ed SAS programu)<\/li>\n
- vypracov\u00e1n\u00ed zpr\u00e1vy o proveden\u00ed studie<\/li>\n
- archivov\u00e1n\u00ed dokumentace<\/li>\n<\/ul>\n
QA \/ QC<\/strong><\/p>\n
- \n
- zaji\u0161t\u011bn\u00ed a kontrola jakosti ve v\u0161ech etap\u00e1ch studie<\/li>\n<\/ul>\n<\/div>
- Typy studi\u00ed<\/div><\/a><\/li><\/ul><\/div>\n
Typy studi\u00ed<\/h2>\n
Dle po\u017eadavk\u016f zadavatele prov\u00e1d\u00edme studie \u00a0r\u016fzn\u00e9ho designu v\u010detn\u011b statistick\u00e9ho vyhodnocen\u00ed nap\u0159:<\/p>\n
- \n
- Farmakokinetick\u00e9 studie<\/li>\n
- Toxikokinetick\u00e9 studie (zv\u00ed\u0159ata)<\/li>\n
- Farmakodynamick\u00e9 studie v\u010detn\u011b hodnocen\u00ed klinick\u00fdch parametr\u016f<\/li>\n
- Biologick\u00e1 dostupnost<\/li>\n
- Bioekvivalen\u010dn\u00ed studie<\/li>\n
- D\u00e1vkov\u00e1 linearita<\/li>\n
- R\u016fzn\u00e9 zp\u016fsoby pod\u00e1n\u00ed \/ r\u016fzn\u00e9 l\u00e9kov\u00e9 formy<\/li>\n
- Steady-state studies<\/li>\n
- In vitro in vivo korelace<\/li>\n
- Interakce l\u00e9\u010div, potravin nebo alkoholu<\/li>\n
- Vliv stravy (nala\u010dno \/ po pod\u00e1n\u00ed stravy)<\/li>\n
- Vliv v\u011bku \/ pohlav\u00ed<\/li>\n
- Studie na speci\u00e1ln\u00ed populaci<\/li>\n
- Ethno-bridging studies<\/li>\n
- Studie na populaci se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami<\/li>\n<\/ul>\n<\/div>
- Speci\u00e1ln\u00ed populace subjekt\u016f<\/div><\/a><\/li><\/ul><\/div>\n
Speci\u00e1ln\u00ed populace subjekt\u016f<\/h2>\n
Quinta-Analytica s.r.o. m\u00e1 k dispozici rozs\u00e1hlou datab\u00e1zi (pool) aktivn\u00edch zdrav\u00fdch dobrovoln\u00edk\u016f a zajist\u00ed dle po\u017eadavk\u016f zadavatele tak\u00e9 speci\u00e1ln\u00ed populace dobrovoln\u00edk\u016f anebo populace subjekt\u016f se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami. Pro pot\u0159eby zaji\u0161t\u011bn\u00ed dob\u0159e definovan\u00e9 skupiny subjekt\u016f pro I.-IIa. f\u00e1ze \u00fazce spolupracujeme se soci\u00e1ln\u00edmi nebo zdravotn\u00edmi za\u0159\u00edzen\u00edmi. Tito subjekty slou\u017e\u00ed k proveden\u00ed bioekvivalen\u010dn\u00edch\/farmakokinetick\u00fdch studi\u00ed nebo studi\u00ed I-IIa f\u00e1ze. Zajist\u00edme se spolupr\u00e1ci proveden\u00ed toxikokinetick\u00fdch anebo dal\u0161\u00edch farmakokinetick\u00fdch studi\u00ed na zv\u00ed\u0159atech. Jedn\u00e1 se o tyto c\u00edlov\u00e9 skupiny:<\/p>\n
- \n
- preklinick\u00e1 \u010d\u00e1st \u2013ve spolupr\u00e1ci zaji\u0161t\u011bn\u00ed studie na zv\u00ed\u0159atech (toxikokinetika, farmakokinetika)<\/li>\n
- zdrav\u00ed mu\u017ei a \u017eeny<\/li>\n
- speci\u00e1ln\u00ed populace:<\/li>\n<\/ul>\n
- \n
- \n
- \n
- sta\u0159\u00ed mu\u017ei a \u017eeny (> 65 let)<\/li>\n
- postmenopauz\u00e1ln\u00ed \u017eeny<\/li>\n
- subjekty s nadv\u00e1hou \/ ob\u00e9zn\u00ed<\/li>\n
- subjekty asijsk\u00e9ho p\u016fvodu<\/li>\n
- rychl\u00ed \/ pomal\u00ed metaboliz\u00e9\u0159i<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
- \n
- populace se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami:\n
- \n
- subjekty s po\u0161kozen\u00edm ledvin<\/li>\n
- subjekty s po\u0161kozen\u00edm jater<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div>
- Design studi\u00ed<\/div><\/a><\/li><\/ul><\/div>\n
Design studi\u00ed<\/h2>\n
Zajist\u00edme studie s r\u016fzn\u00fdm designem dle po\u017eadavk\u016f zadavatele v\u010detn\u011b konzultac\u00ed. Jedn\u00e1 se nap\u0159. o tyto studie:<\/p>\n
- \n
- Jedna nebo v\u00edce periodick\u00e9 studie<\/li>\n
- Paraleln\u00ed, s\u00e9riov\u00fd nebo crossover design<\/li>\n
- Otev\u0159en\u00e9 (nezaslepen\u00e9) studie<\/li>\n
- Zaslepen\u00e9 \u010di dvojit\u011b zaslepen\u00e9 studie<\/li>\n
- Ambulantn\u00ed nebo hospitaliza\u010dn\u00ed<\/li>\n
- Pilotn\u00ed a pivot\u00e1ln\u00ed studie<\/li>\n<\/ul>\n<\/div>
- QA & QC<\/div><\/a><\/li><\/ul><\/div>\n
QA & QC<\/h2>\n
Ka\u017ed\u00e1 studie prob\u00edh\u00e1 v souladu se standardy Spr\u00e1vn\u00e9 klinick\u00e9 praxe (SKP) a Spr\u00e1vn\u00e9 laboratorn\u00ed praxe (SLP). Jednotka ji\u0161t\u011bn\u00ed a kontroly kvality (QAU) dle vnit\u0159n\u00edch p\u0159edpis\u016f sleduje dodr\u017eov\u00e1n\u00ed ka\u017ed\u00e9ho kroku od pl\u00e1nov\u00e1n\u00ed (protokol studie), p\u0159es pod\u00e1n\u00ed na Etickou komisi a St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div, proveden\u00ed vlastn\u00ed studie a jej\u00ed zdokumentov\u00e1n\u00ed a\u017e po naps\u00e1n\u00ed z\u00e1v\u011bre\u010dn\u00e9 zpr\u00e1vy. Ve\u0161ker\u00e9 \u010dinnosti prob\u00edhaj\u00ed dle Standardn\u00edch opera\u010dn\u00edch postup\u016f (SOPs) a Protokolu studie.<\/p>\n
\u00dadaje zaznamenan\u00e9 p\u0159i studii, p\u0159enos dat a zpr\u00e1vy proch\u00e1zej\u00ed 100% kontrolou kvality p\u0159ed z\u00e1v\u011bre\u010dn\u00fdm auditem studie jednotkou ji\u0161t\u011bn\u00ed jakosti.<\/p>\n
Pracovn\u00edci QAU zorganizuj\u00ed monitoring studi\u00ed, pokud prob\u00edhaj\u00ed mimo prostory na\u0161eho klinick\u00e9ho za\u0159\u00edzen\u00ed (studie II.-IV f\u00e1ze) a pokud zadavatel na na\u0161e CRO tuto \u010dinnost delegoval. Monitoring studi\u00ed prob\u00edh\u00e1 v souladu s legislativn\u00edmi p\u0159edpisy, po\u017eadavky zadavatele a dle na\u0161ich SOP.<\/p>\n
Pracovn\u00edci QAU mohou na \u017e\u00e1dost druh\u00e9 strany prov\u00e9st nez\u00e1visl\u00fd audit GCP. Audit prob\u00edh\u00e1 na z\u00e1klad\u011b legislativn\u00edch po\u017eadavk\u016f a dle na\u0161ich SOP.<\/div><\/div><\/div><\/div><\/div><\/div><\/div>
<\/div><\/div><\/span>Additional Services<\/h2><\/span>
<\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/span>NITROSAMINES ANALYSIS<\/h4><\/span>
<\/div><\/div><\/div>Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.<\/p>\n<\/div>
<\/div><\/div><\/span>More Info <\/i><\/a><\/h1><\/span>
<\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/span>MONITORING STUDI\u00cd<\/h4><\/span>
<\/div><\/div><\/div>Oversight of participant health and correctness of treatments during clinical studies.<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/span>FARMAKOVIGILANCE<\/h4><\/span>
<\/div><\/div><\/div>Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/span>AUDIT MODULU 3<\/h4><\/span>
<\/div><\/div><\/div>Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.<\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/span>KOMPILACE IMPD<\/h4><\/span>
<\/div><\/div><\/div>As an EU based company we are well-placed to help create & develop your IMPD.<\/p>\n<\/div><\/div><\/div>
- populace se speci\u00e1ln\u00edmi zdravotn\u00edmi podm\u00ednkami:\n
- \n
- zaji\u0161t\u011bn\u00ed a kontrola jakosti ve v\u0161ech etap\u00e1ch studie<\/li>\n<\/ul>\n<\/div>