Icandelo lokuKhula, ii-CROs Dlala indima enkulu ekuPhuhliseni iMida
Kwizoqoqosho ezitshintshayo, iinkampani zonyango zijonge ngokubhekisele kwimisebenzi ebalulekileyo, kuquka ukuveliswa kunye nophando. Uninzi lweenkampani ezinkulu zisebenzisa i-CRO ukuqhuba izilingo zekliniki kunye nokuphuhlisa amayeza amasha.
Iyini Inkontileka yoPhando yeMvumelwano?
I-CRO yintlangano enikwa enye inkampani ukulawula nokukhokela iimvavanyo, imisebenzi kunye nemisebenzi yenkampani.
Imibutho kunye namashishini anesivumelwano kunye nee-CRO zenza njalo ukufumana ubuchule obucacileyo ngaphandle kokuqesha abasebenzi abasisigxina. Amaqela eentengiso ze-CRO athi xa amafemu okanye iinkampani zikawonkewonke ziphuma kwi-CRO, ukunciphisa ixesha elithathayo ukuqhuba isilingo ngokubhekiselele kwisilingo endlwini, kwaye iguqulela kwiindleko ezinkulu zokugcina imali. Inkontileka kunye nenkampani yangaphandle ithetha ukuba inhlangano yokuqeshisa ayifuni izakhiwo, indawo yeofisi okanye umntu osebenzayo ukuqhuba ezi zilingo ngokwabo.
Ezinye i-CRO zilawula phantse zonke iinkalo zetyala lekliniki, ukusuka ekukhethweni kwendawo kunye nokubhaliswa kwesigulane ngokugunyazwa kokugqibela okuvela kwi-Food and Drug Administration kunye ne-Arhente yezoMiYurophu.
Nangona umxhasi wexilongo angadlulisela yonke imisebenzi yesilingo kwi-CRO yesithathu, umxhasi uyahlala enoxanduva lobungqina benkcazelo yesilingo kunye nokuqinisekisa ukuba yonke into iyinyani kwaye ixhaswa yi-nzu lulwazi.
Iintlobo zeeNkonzo ezibonelelwe yi-CROs
Imibutho yophando yontengiso inikeza iinkonzo ezibanzi, kubandakanywa:
- Ulawulo lweprokjekthi
- Uyilo lovimba kunye nokwakha
- Ukungena kwedatha nokuqinisekiswa
- Ulawulo lweenkcukacha zovavanyo lwezonyango
- Amachiza kunye nezifo zokubhala
- Umgangatho kunye nokunika ingxelo ngemetriki
- Izicwangciso zokuhlalutya izibalo kunye neengxelo
- Inkqubo yokuqinisekisa
- Ukhuseleko kunye neempumelelo
- Ingxelo yokugqibela yokufunda
Umbutho weeNkampani zoPhando lweeNkcazo uqikelele ukuba ngaphezu kwe-50 ekhulwini ze-CRO zenza umsebenzi wokufunda okliniki kwiinkampani zonyango, i-27 ekhulwini isebenza kwii-biotechs kunye ntsalela yoshishino lwezonyango, iziseko kunye noorhulumente. Phakathi kwama-CRO asebenza kunye neenkampani zonyango, iindawo eziphambili zonyango ziyi-oncology, inkqubo ye-nervous central (CNS), izifo ezithathelwanayo, izifo ezixubileyo kunye nesifo senhliziyo.
I-shishini elingazange libe khona iminyaka elishumi eyadlulayo, icandelo le-CRO lenza kakuhle kakhulu xa kuthelekiswa namanye amashishini.Kuba iinkampani zonyango kunye nemibutho yonyango zijongene nokunyuka kwengcinezelo kwiindleko eziphezulu zamachiza, zifuna iindlela zokunciphisa iindleko zeziyobisi ezingekho phantsi kwemali ngaphandle kokulahlekelwa inzuzo . Ulawulo lokuvavanywa kwezilingo zeklinikhi yindlela yokuba ezi nkampani zihlawule iindleko ezingaphezulu, zibancedise ukuba zenze iirado ezilahlekileyo ngenxa yamanani amayeza aphantsi.
Imibutho yophando yekhontrakthi inikezela ngepropati ekwazi ukuhlawuleka kakhulu kwiinkampani ukulandela imishanguzo emitsha. Ngaphambi, ukulandela imvume yokusetyenziswa kweziyobisi kwakudla ngokukhawuleza, kwaye ngokuqhelekileyo kwenzeka kuphela xa kubonakala kukuvunyelwene ngokuqinisekileyo kweemarike ezinkulu.
Ubukho be-CRO buyindleko eninzi, ivumela iinkampani ukuba ziphuhlise izidakamizwa ezincinci kubaphulaphuli be-niche.
Nangona oku kungomnye uphawu lokuba icandelo lishintsha ngokukhawuleza, bubungqina bokuba iinkampani zonyango ziguqukela ukuhlangabezana neemfuno zoqoqosho olutsha kunye nokucwangcisa iinkqubo ukuhlangabezana neemfuno zezigulane kunye nabanini-nxaxheba.