Clinical Trial EDC System

2017-02-21 14:25:41
MicroConstants China works its partners to bring well tested Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) systems to China to help our partnering clinical sites and clients manage clinical projects better. 
INSTEM ALPHADAS CTMS/EDC is a site automation tool that is clinically driven to better manage and streamline the clinical trial process. Resources are tightly managed and key data entered only once but used for multiple purposes. 
The ALPHADAS system has been used in over twenty clinical sites worldwide covering 1,500 early phase beds from pharmaceutical companies, CROs and clinical research institutes. Now it has expanded into Phase II/III clinical trial management and multiple site management. It also provides seamless, automated integration with other technology platforms such as Sponsor EDC (Medidata RAVE), central laboratory LIMS, medical device (Mortara), and data management systems. It allows for real-time online review and reporting of clean data. 
The ALPHADAS CTMS Key Features are:
  • Study Subject Management 
  • Study Builder 
  • Staff & Resource Scheduler 
  • Master Document Creation for Protocol/CRF 
  • Barcode generator 
ALPHADAS EDC-Bedside 'Critical' eSource data collection (web app) 
  • Workflow Data collection direct from the bedside, eSource and from medical devices 
  • Reliable and off-line – local redundancy – data collection continues with internet or local network failures 
  • Single/multiple subject view 
  • Study Subject input screen (diaries/scales/VAS/questionnaires) 
  • Language Interface 
  • Graphical display of collected data 
  • Immediate addition of unscheduled events 
  • Data available for immediate review and reporting via ‘Netview’ 
  • Tracks barcoded samples from ‘draw to dispatch 
  • Multi-site (for the Sponsor) and Multi-Sponsor system (for the Site)

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