Ukugxila embonini

Ukuhunyushwa kwemithi nocwaningo lwezempilo

Izinguqulo zezinga eliphezulu zezinkampani zemithi, ama-CRO nokufakwa kwezicelo kubalawuli.

Sisiza izinkampani zemithi nezinhlangano zocwaningo lwezempilo ukuthi zilawule amadokhumenti ngezilimi eziningi phakathi nokuphila komkhiqizo.

Ukuhumusha kwemithi kuhlanganisa ucwaningo lokuqala, ukuthuthukiswa kwezempilo, ukufakwa kwezicelo kubalawuli nokuxhumana ngokuphepha ngemva kokudayisa. Ukunemba nokuhambisana kubaluleke kakhulu ngoba okuqukethwe okuhunyushiwe kubuyekezwa abalawuli, amakomidi okuziphatha, abacwaningi neziguli. Amathimba ethu asebenza emadokhumentini okuhlolwa kwemithi, izinto ezibhekiswe ezigulini, ama-regulatory dossier, imibiko ye-pharmacovigilance, ama-SmPC nama-PIL. Siqondanisa namagama asetshenziswa yi-EMA, FDA nezinye izinhlangano lapho kufanele khona futhi silandela isitayela sakho sangaphakathi nezinhlaka zezifanekiso. Kungakhathaliseki ukuthi wenza ukuhlolwa komhlaba wonke noma ulawula imikhiqizo evuthiwe ezimakethe eziningi, sikusiza ukuthi ugcine amadokhumenti athembekile ngezilimi eziningi futhi unciphise ubungozi bokungaqondakali kahle.

Izazi zolimi zomdabu ezinolwazi embonini ≥ 100 iziphetho zolimi ezitholakalayo

Thola isilinganiso salo mboni Khuluma nomphathi wephrojekthi

Ukuhunyushwa kwemithi nocwaningo lwezempilo

Imibhalo evamile esiyihumushela ku- Ezomithi.

Ngezansi kukhona ezinye zezinhlobo zemibhalo evamile esizisingatha kumakhasimende kule nkundla. Uma izinto zakho zihlukile kancane, thumela isampula futhi sizoqinisekisa indlela engcono kakhulu yokusebenza kanye nezikhathi zokuphothula.

Izivumelwano zokuhlola imithi nama-IB
Amafomu emvume enolwazi namadayari eziguli
Ukufakwa kwezicelo kubalawuli namadokhumenti okushintsha
Ama-SmPC, ama-PIL nemibhalo yokulebula
Imibiko ye-pharmacovigilance nokuphepha
Ulwazi lwezempilo nokuxhumana nama-HCP

Izinselele ezivamile ku- Ezomithi ukwenza kube ngolimi lwendawo.

Yonke imboni inamagama ayo akhethekile, okulindelwe yizinhlaka ezithintekayo kanye nezinga lengcuphe. Sakha izindlela zethu zokusebenza ngokuhambisana nalezi ziqiniso ukuze ukuhumusha kusebenze ngempela, hhayi nje ephepheni.

Ukuhumusha amadokhumenti ezesayensi anocwaningo olunzulu.
Ukuqinisekisa ukuthobela imithetho ngokugcwele ezifundeni eziningi.
Ukulawula amagama kuwo wonke amathimba ezempilo, awokumaketha nawokulawula.
Ukugcina ukunemba emithini, ezixwayisweni nasezifundweni.

Indlela ejwayelekile ye- Ezomithi iphrojekthi yokuhumusha isebenza kanjani.

Noma uthumela umbhalo owodwa noma umkhankaso ophelele, silandela inqubo ehleliwe ukuze wazi kahle ukuthi kuzokwenzekani kusukela efayeleni lokuqala kuze kube ekulethweni kokugcina.

1 Isilinganiso "esingenamangaliso"

Thumela amafayela akho, izikhathi zokuphothula kanye nanoma yikuphi ukuhumusha okwedlule. Siqinisekisa ububanzi, ukuhlanganiswa kwezilimi kanye nemiyalelo ethize ngaphambi kokuthi umsebenzi uqale.

2 Ukuhumusha okukhethekile embonini

Izinto zakho zinikezwa izazi zolimi zomdabu ezinolwazi olufanele emkhakheni, zisekelwa yizinkomba zamagama, iziqondiso zesitayela kanye nezinto zokubhekisela.

3 Ukubuyekezwa, ukuqinisekisa ikhwalithi & ukulethwa

Isazi solimi sesibili sibuyekeza ukuhumusha, ithimba lethu lenza ukuhlola kokugcina kwekhwalithi, futhi siletha ngefomethi oyithandayo noma ngqo ezinhlelweni zakho lapho kudingeka khona.

Kungani i-TranslationServicesWorld.com ye- Ezomithi?

Sihlanganisa ubuchwepheshe bemboni nezindlela zokuhumusha ezilawulwa kahle, ukuze amaqembu akho akwazi ukuthembela emibhalweni yokugcina ngaphandle kokuhlola kabusha umugqa ngamunye. Inhloso yethu ukuba ngumlingani wesikhathi eside wenhlangano yakho kunokuba sibe ngumhlinzeki oyedwa nje.

Ulimi oluqondiswe kubalawuli

Silandela amagama namafomethi alindelwe yiziphathimandla zezempilo ezinkulu.

Ukugxila okukabili ezigulini nabasebenzi

Senza ulimi lufaneleke amadokhumenti abhekiswe ezigulini nalawo abhekiswe kuma-HCP.

Ukwesekwa kohlelo lomhlaba wonke

Sisekela ukuhlolwa kwamazwe amaningi nokwethulwa kwemikhiqizo ngokuqukethwe okufanayo ngezilimi eziningi.

Inqubo yethu yokuhumusha ehlelwe nge- Ezomithi.

Izimboni ezihlukene zidinga izindlela zokusebenza ezihlukene. Kule nkundla, sigxila ekunembeni, ekulandeleleni kanye nokugcinwa kuyimfihlo esigabeni ngasinye kuyilapho sigcina inqubo ilula emaqenjini akho angaphakathi.

Ukuhunyushwa kwemithi nocwaningo lwezempilo Workflow

1. Ukuhlelwa komkhiqizo nezwe

Sihlela imikhiqizo, izifundo nezimakethe eziqondisiwe ngenjongo yezinguqulo ezihleliwe.

2. Ukuhumusha amathimba aqonda ezomithi

Abahumushi nababuyekezi abakhethekile baphatha amadokhumenti omkhiqizo wakho nawocwaningo.

3. Ukuhlola ikhwalithi nokulawulwa kwamagama

Sisebenzisa ukubuyekeza ngezinyathelo eziningi ukuze sigcine amagama namaphuzu edatha efana.

4. Ukusekela ukubuyekeza phakathi nokuphila komkhiqizo

Sisekela izibuyekezo zokuphepha, izinguquko nezinkomba ezintsha kuzo zonke izilimi.

Ukuqinisekisa ikhwalithi & izigaba zokubuyekezwa

Emaphrojekthini amaningi sincoma ukuhumusha kanye nokubuyekezwa okuzimele. Emibhalweni enengozi enkulu noma ebonakala kakhulu, singengeza isigaba esengeziwe sokucaca kanye nokungaguquguquki.

Izibonelo zamaphrojekthi ku- Ezomithi.

Nansi ezinye izibonelo zokuthi amakhasimende kulo mkhakha asebenzisa kanjani izinsizakalo zethu zokuhumusha. Imininingwane ifihliwe, kodwa ibonisa ububanzi obujwayelekile, izilimi kanye nemiphumela evamile.

Ucwaningo lwe-oncology lamazwe amaningi

Amadokhumenti okuhlola kuhunyushelwe ezilimini eziyi-14 ngenjongo yezindawo zabacwaningi neziguli kuye e-Europe nase-Asia.
Ukwenza ulwazi lomkhiqizo lufaneleke indawo

Ama-SmPC, ama-PIL nemibhalo yokupakisha kwasetshenzwa kwafaneleka izindawo zasendaweni ngenjongo yemithi kadokotela ehlukahlukene engena ezimakethe ezintsha.

Uhlela iphrojekthi entsha?
Thumela isampula yombhalo noma isifinyezo futhi sizohlinzeka ngohlelo olusebenzayo, izindleko kanye nesikhathi.

Qala ngesilinganiso esisheshayo