關於翔悅:


        翔悅生技成立於2013年,專長於臨床試驗
SMO(Site Management Organization)管理。


        擁有豐富的臨床試驗執行團隊,提供專業的臨床研究護理專員(
Clinical Research Coordinator),以建構完整、嚴謹的標準作業流程(SOP)及符合藥品優良臨床試驗規範(GCP),協助執行臨床試驗,建立良好臨床試驗環境,加速受試者招募,提升臨床試驗品質,推動全球新藥之發展。

 

Providing Quickly, Accurately and Professionally SMO Service.


        FLY-WIN established in 2013, is a Site Management Organization, our objective is to provide professional clinical research coordinators, accelerated recruitment of clinical subjects, increase the quality of clinical trials and aid in the development of new drugs.


        We continually make every effort to be the finest resource for you and to ensure that we satisfy your specific and unique needs.


願景:
成為亞太地區SMO服務的第一首選。

VisionTo be the first choice of SMO services in Asia


宗旨:
承諾永遠秉持專業、高品質與客戶的需求

MissionProvide insight & expertise services to ensure successfulness of a clinical trial

 

選擇翔悅:


Background
臨床研究護理專員(Clinical Research Coordinator),
皆具專業醫療背景(均臨床護理年資7年)。


Training
完整的職前及在職臨床試驗教育訓練,能有效的進行全方位的溝通及協調工作,加速臨床試驗的收案率及完成率。


Experience
執行臨床試驗第一期至第四期(平均執行臨床試驗年資5年)之全球性及台灣區研究計劃,其研究治療領域涵蓋18種適應症。


Quality
給予持續的教育訓練,定期之品管監控,可減少試驗主持人承擔訓練時間及雇用風險。


Location
人員分佈於台灣各大醫學中心/區域教學醫院。

 

  • Provide multiple, qualified sites only with one phone call
  • Abundant Database of professional, experienced and enthusiastic Investigators
  • Dedicated, fulfilled, and experienced Clinical Research Coordinators
  • Conduct Phase I to Phase IV studies
  • Ability to conduct inpatient and outpatient studies
  • Aggressive patient recruitment strategy to support local sites
  • Strong relationships with local and central IRB and laboratories
  • Established and stable relationships with public, private and military institutions
  • Stabled, efficiently and mutually beneficial working relationships with Investigative sites
  • Proven ability to successfully conduct even the most challenging study

 

計畫流程01.jpg    


Fly-WIN Company Highlights


服務項目Service items:

  • Site Management (Clinical Research Coordinator):臨床研究護理專員
  • Quality check / QC Report:品質管理與報告
  • Pre-screening & Recruitment:篩選受試者及提升收案率
  • Trial Management:臨床試驗專案管理    
  • Sponsor Site Visit:協助廠商拜訪各醫學中心
  • Assist Submission:協助臨床試驗案件送審
  • Verify Feasibility Study:核對臨床試驗案可行性調查
  • Education / Training Program:臨床試驗相關課程
  • Serious Adverse Event Report:嚴重不良反應通報
  • Investigator Database:試驗主持人資料庫


 

治療領域 Therapeutic Area:

計畫流程02.jpg  

 

聯絡我們:

公司電話: 02-22648982

傳真: 02-22648926

email: flywin2@gmail.com

地址:新北市土城區學士路23號3樓

 

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