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  • Pharmacovigilance

    Fun idaniloju aabo oogun, o ṣe pataki lati ṣe iṣiro deede awọn eewu oogun ati mu awọn igbese to baamu, eyiti o nilo awọn alamọdaju iṣakoso ailewu lati gba, ṣawari, ṣe ayẹwo, ṣe abojuto ati ṣe idiwọ awọn aati ikolu lakoko idagbasoke oogun si titaja lẹhin-tita oogun.

Pharmacovigilance ati Ile-iṣẹ Ipe

Pharmacovigilance ati Ile-iṣẹ Ipe

Nipa didasilẹ ile-iṣẹ ipe Integration Data Itanna (EDI), o ṣẹda ikanni ibaraẹnisọrọ laarin awọn ile-iṣẹ ati awọn alabara ti yoo ṣafipamọ awọn idiyele R&D ati ṣe iranlọwọ lati ṣe atẹle awọn ewu ti o ni ibatan aabo ti awọn oogun / awọn ẹrọ iṣoogun, igbelaruge ilera gbogbogbo, ati pese awọn alabara lọpọlọpọ ti didara giga, awọn iṣẹ to munadoko.

    Pe wa
    ọja alaye
    ọja apejuwe

    apejuwe1

    apejuwe2

    Ẹgbẹ elegbogi CSC jẹ ti kariaye ati ti o ni iriri ipele giga, awọn ọmọ ẹgbẹ ti o ni oye pẹlu awọn agbara ti awọn ọgbọn ede lọpọlọpọ, fun apẹẹrẹ, Gẹẹsi, Japanese, Korean lẹgbẹẹ Kannada. CSC tun ni eto ikẹkọ PV okeerẹ ati lẹsẹsẹ awọn SOPs PV ti o ni ibamu pẹlu awọn ibeere ilana, ati nigbagbogbo san ifojusi si awọn imudojuiwọn ti awọn ofin ati ilana elegbogi ati ṣeto awọn ibaraẹnisọrọ nigbagbogbo ati ijiroro pẹlu awọn alamọja ile-iṣẹ PV ati awọn olutọsọna lati rii daju pe ipele ti awọn alamọja aabo oogun lori iṣakoso awọn ofin ile elegbogi ati oye ti kariaye.
    Pẹlu oye okeerẹ ti awọn ilana ti awọn orilẹ-ede pupọ gẹgẹbi China, United States, Japan, Australia, New Zealand, Qatar ati EMA, ẹgbẹ elegbogi ti ṣe awọn ọgọọgọrun ti awọn iṣẹ akanṣe inu ile ati ti kariaye, ti o kan ninu awọn aaye iṣoogun iṣoogun ti Onkoloji, atẹgun, ajẹsara rheumatologically, itọju ilera idena, ophthalmology pẹlu oogun-igbẹkẹle ati ilana Iṣeduro Iṣoogun ti oogun. idanwo, oluṣewadii-ibẹrẹ awọn idanwo ile-iwosan gẹgẹbi awọn ẹrọ iṣoogun ati awọn iṣẹ iwosan lẹhin-ọja.
    Lati le ba awọn ibeere onigbowo/alabaṣepọ pade, gbogbo ẹgbẹ le ṣe idahun ni kikun, safi ipa kankan ati ifowosowopo ni itara lati pari awọn iṣẹ ṣiṣe lọpọlọpọ. Ilana iṣapeye wa, awọn ọgbọn okeerẹ ati awọn oṣiṣẹ PV iyalẹnu le pese awọn iṣẹ didara ga fun awọn onigbọwọ, ati rii daju pe iṣowo elegbogi onigbowo yoo gba ipo ifigagbaga ni ile-iṣẹ naa.

    A le pese awọn iṣẹ isale ṣugbọn kii ṣe opin:

    Abojuto oogun lekoko

    Oògùn ailewu alaye isakoso

    Iroyin ailewu ọran kọọkan

    Medical awotẹlẹ

    Litireso wiwa ati processing

    Wiwa ifihan agbara ati iṣakoso

    Awọn ijabọ imudojuiwọn aabo igbakọọkan

    Idagbasoke Abo Update Iroyin

    Awọn eto iṣakoso eewu idagbasoke

    Alaye Aabo Lakotan Analysis ati Iroyin

    Ikole ati itoju ti elegbogi eto

    Pharmacovigilance Consultancy

    Pharmacovigilance aaye data

    • Ile-iṣẹ ipe

      Nipa idasile ile-iṣẹ ipe Itanna Data Integration (EDI), ẹgbẹ CSC PV ṣe iranlọwọ fun awọn alabara wa lati ṣẹda ikanni ibaraẹnisọrọ pẹlu awọn alaisan, eyiti o le ṣafipamọ awọn idiyele R&D ati ṣe iranlọwọ lati daabobo awọn ewu ti o yẹ ti awọn oogun / awọn ẹrọ iṣoogun, igbega ilera gbogbogbo.

    Ile-iṣẹ ipe ni sipesifikesonu iṣẹ iṣọkan ati eto iṣakoso, ni ipese pẹlu alamọdaju, iwọnwọn, awọn iṣẹ ti ara ẹni, ati nipasẹ awọn ọna imọ-ẹrọ lati dinku awọn idiyele iṣẹ iṣowo ile-iṣẹ. O le ni irọrun pese ọpọlọpọ awọn iṣẹ ni ibamu si awọn iwulo alabara tabi awọn ibeere, ati ni anfani lati mu iwọn awọn ipe nla ni akoko kanna pẹlu gbigbasilẹ ati ibi ipamọ ti gbogbo alaye ti nwọle nipasẹ awọn ipe. Iru okeerẹ ati awọn iṣẹ deede ko le ṣe ilọsiwaju ṣiṣe ti iṣakoso alaye ailewu nikan, ṣugbọn dinku awọn ẹru iṣẹ ti awọn ile-iṣẹ lori awọn ibeere PV ilana. Pẹlupẹlu, Ile-iṣẹ Ipe ti ṣeto faaji ipilẹ iduroṣinṣin, awọn laini igbẹkẹle ati eto awọn itaniji aabo.

    Ẹgbẹ wa ni oye ni awọn iṣẹ wọnyi:

    Olurannileti ibewo koko-ọrọ

    Iranti oogun koko-ọrọ

    Ọja ailewu alaye gbigba

    Ọja didara ẹdun

    Ayẹwo koko-ọrọ ati igbanisiṣẹ

    Pre-tita / lẹhin-tita iṣẹ

    Iwe ibeere

    FAQ

    Miiran gbigba alaye

    KBM

    olumulo alaye isakoso

    Iṣakoso idawọle

    Data onínọmbà ati iroyin