UI yakasarudza Intrinsik Corp., kambani inobvunzurudza nyaya dzepasi rose inocherechedzwa pasi rose, kuti ipe hurongwa hwekutonga nerutsigiro rwekugadzirira uye kuendesa UI's Canadian Clinical Trial Application, pamwe nekutevera nekutarisa kana Tsamba Inorambwa ikagamuchirwa kubva kuHutano. Kanadha. Intrinsik inoumbwa nechikwata chine ruzivo rwakamhanyisa mazana ezviyedzo zvekiriniki zvakabudirira uye kuongorora mashandisirwo emishonga mitsva uye vakabatana vakabatsira kune zvinopfuura makumi maviri zvekushambadzira zvinodhaka zvitsva. Iri boka rine pamusoro pe20 regulatory affairs affairs based in the Canadian headquarters iri munzvimbo yakakura yeToronto, uye hunyanzvi husingaenzaniswi uye ruzivo zvine chekuita neCentral Nervous System Disorders (CNS: nzvimbo yekurapa iyo kupindwa muropa uye kusagadzikana kwehutano hwepfungwa).
Rutsigiro rwekuvandudzwa kwezvinhu zveCTA package, pamwe nekupedzisira kushanda kwekiriniki yekuedza pachayo, iri kupihwa neboka repasi rose kuCATO Research Canada Inc. Chikwata cheCATO SMS chenyanzvi chine makore anopfuura makumi matatu. ' ruzivo rwekugadzirisa dhizaini uye kuita kwekiriniki kuyedzwa kumakambani esainzi ehupenyu seUI. CATO SMS yakabudirira kuita mazana mashanu ekuyedzwa kwekiriniki munyika dzinopfuura makumi maviri neshanu uye yakanyoresa varwere vanopfuura zviuru makumi matanhatu munzvimbo dzinopfuura zviuru zvishanu nemazana mashanu.
Chikwata cheCATO SMS chekubatanidzwa, pamwe nechikwata cheUI, chinosanganisira nyanzvi dzakasiyana muCanada, US neEurope, ichipa hunyanzvi hwakakosha kubva pamagadzirirwo ezvidzidzo zvekiriniki kusvika kubiostatistics kuenda kumabasa ekiriniki (semuenzaniso, kutora varwere, kutanga kudzidza, bhajeti, manejimendi enzvimbo. , data management, nezvimwewo). Mipiro yeCATO SMS 'inozobatanidzawo kuongororwa uye kuumbwa kwezvinyorwa zvepanyika-chaiyo data uye humbowo ("RWD" uye "RWE", zvichiteerana) zvichibva mukushandiswa kweibogaine pakurapa opioid kushandiswa kusagadzikana mune vangangoita 200 varwere vakave. akarapwa muCancun, Mexico neanopa rezinesi weUI – Clear Sky Recovery Cancun SA de CV. UI inotenda kuti kuratidzwa kweRWD neRWE sechikamu cheCTA pasuru kuchasimbisa chikumbiro, kunyanya danho rekutanga rekuchengetedza, uye rinoenderana neiri kubuda nhungamiro nevaregi, seUS Food and Drug Administration ("FDA"). kubvuma nekubatanidza RWD neRWE mukukura kwekiriniki, uye kazhinji muuchapupu-hwakavakirwa mushonga.
Chekupedzisira, UI iri kubatanidza nzvimbo dzedzidzo uye dzekurapa dzine mukurumbira kuti dzitsigire CTA kuHutano Canada, pamwe nekukwanisa kushanda senzvimbo dzekuita ongororo yekupedzisira yekiriniki. Zvakanyanya, UI yakapinda hofisi yekutsvagisa yeinotungamira Canada-yakavakirwa mudzidzo uye yekudzidzisa nzvimbo munzvimbo yekurapa yekupindwa muropa kutsigira dhizaini yeprotocol yekudzidza uye kuunza kufarira mukusarudzwa kwesaiti.
