I-UI ikhethe i-Intrinsik Corp., inkampani yokubonisana nemicimbi yolawulo evunyiweyo kwihlabathi, ukubonelela ngesicwangciso solawulo kunye nenkxaso yolungiselelo kunye nokungeniswa kweSicelo seSilingo seKlinikhi saseCanada se-UI, kunye nokulandelelwa kunye nokubeka iliso ukuba akukho Leta yokuchasa ifunyenwe kwiMpilo. Khanada. I-Intrinsik iquka iqela elinamava eliqhube amakhulu olingo lwezonyango oluyimpumelelo kunye nophando lwezicelo zamachiza amatsha kwaye ngokuhlangeneyo libe negalelo kwizicelo ezitsha zokuthengisa amachiza ezingaphezu kwama-20. Iqela linabasebenzi abangaphezulu kwe-25 yemicimbi yolawulo esekelwe kwikomkhulu laseCanada elikwindawo enkulu yaseToronto, kunye nobuchule obungenakulinganiswa kunye namava anxulumene ne-Central Nervous System Disorders (CNS: indawo yonyango apho umlutha kunye nokuphazamiseka kwempilo yengqondo).
Inkxaso yokuphuhliswa kwezinto ze-CTA iphakheji, kunye ekugqibeleni nokusebenza kovavanyo lweklinikhi ngokwayo, inikezelwa liqela lehlabathi kwi-CATO Research Canada Inc. Iqela le-CATO SMS leengcali lineminyaka engaphezu kwe-30. ' amava okuphucula uyilo kunye nokwenziwa kolingo lwezonyango kwiinkampani zesayensi zobomi ezifana ne-UI. I-CATO SMS iqhube ngempumelelo izilingo zeklinikhi ezingama-500 kumazwe angaphezu kwama-25 kwaye ibhalise ngaphezulu kwezigulane ezingama-60,000 kwiindawo ezingaphezu kwama-5,500.
Iqela lokubandakanya i-CATO SMS, kunye neqela le-UI, libandakanya iingcali ezahlukeneyo eCanada, e-US naseYurophu, enikezela ngobuchule obubalulekileyo ukusuka kuyilo lwezifundo zeklinikhi ukuya kwi-biostatistics kwimisebenzi yeklinikhi (umzekelo, ukuqashwa kwezigulane, ukuqaliswa kokufunda, uhlahlo lwabiwo-mali, ulawulo lwesayithi. , ulawulo lwedatha, njl.). Iminikelo ye-CATO ye-SMS iya kubandakanya ukuhlalutya kunye nokuhlanganiswa kwedatha ye-real-world data kunye nobungqina ("RWD" kunye ne "RWE", ngokulandelanayo) ukusuka kwisicelo se-ibogaine kunyango lwe-opioid yokusetyenziswa kwe-opioid malunga nezigulane ze-200 eziye zafunyanwa. iphathwe eCancun, eMexico liqabane le-UI lelayisensi – Clear Sky Recovery Cancun SA de CV. I-UI ikholelwa ukuba ukunikezelwa kwe-RWD kunye ne-RWE njengenxalenye yephakheji ye-CTA iya kuqinisa isicelo, ngokukodwa ibango lokuqala lokhuseleko, kwaye lihambelana nezikhokelo ezivelayo ngabalawuli, njenge-US Food and Drug Administration ("FDA"), ukuvuma kunye nokubandakanya i-RWD kunye ne-RWE kuphuhliso lwezonyango, kwaye ngokubanzi kwiyeza elisekelwe kubungqina.
Okokugqibela, i-UI idibanisa amaziko emfundo ephakamileyo kunye namaziko ezonyango ukuxhasa i-CTA kwi-Health Canada, kunye nokusebenza njengeendawo zokwenza ulingo lwezonyango lokugqibela. Ngokucacileyo, i-UI ibandakanye iofisi yophando yeziko eliphambili lezemfundo kunye nelokufundisa laseCanada kwindawo yonyango yokulutha ukuxhasa uyilo lomgaqo wokufunda kunye nokwenza umdla ekukhetheni indawo yovavanyo.
INTO ONOKUYITHATHA KWELI NQAKU:
- UI believes that the presentation of RWD and RWE as part of the CTA package will strengthen the application, particularly the preliminary claim to safety, and is aligned with emerging guidance by regulators, such as the US Food and Drug Administration (“FDA”), to acknowledge and incorporate RWD and RWE in clinical development, and generally in evidence-based medicine.
- Notably, UI has engaged the research office of a leading Canada-based academic and teaching institution in the therapeutic area of addiction to support the design of the study protocol and generate interest in trial site selection.
- Support for the development of the substance of the CTA package, as well as ultimately the operation of the clinical trial itself, is being provided by the world-class team at CATO Research Canada Inc.
