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Comprehensive EDC


Comprehensive EDC

Over the past 20 years technology has changed seemingly on a daily basis. New visual technologies, data collection methods, transport methods, and physical hardware have spawned many different approaches to software. EDC is an area under constant change.

The Acceliant EDC system has adapted to the rapidly changing technologies and continuously changing users in the market. The Acceliant eClinical Suite Management Team recognizes the need for a comprehensive EDC system that stays current with technology and user needs, assisting in a system that has the following features:

  • Provides native support for paper processes and EDC processes within the same study
  • Electronically collects, cleans, and manages clinical trial data
  • Enables dual-data entry, including blinded and interactive verification modes
  • Tracks paper CRF pages, including missing or duplicate pages in entry and archived pages
  • Integrated coding module supports industry standard dictionaries such as MEDRA 4.0, WHODRUG, and user-defined dictionaries with synonym support
  • Imports external data such as laboratory data with simple mapping and commit interfaces
  • Monitors compare source documents online against captured data
  • Generates case report forms and database structure in one step to automate deployment of trials
  • Supports design once and deploy in many formats, including Web, paper, and handheld devices
  • Monitors multi-record table parameters at a glance with an ability to switch row to a column view
  • Enables form versioning to manage protocol amendments with support of multiple versions of CRF at any point in time; selectable on a per-site basis
  • Permits users to delete subject, visits, and pages from CRF
  • Globally updates data across CRF pages and subjects
  • Provides point-and-click interface to export collected data
  • Uploads, stores, manages, and links trial documents with other clinical data in an audited, version-controlled manner in a central data repository
  • Rapidly locks database at the end of a trial
  • Provides integrated reporting module using crystal reports
  • Reviews, prints, and tracks queries for paper-based sites in the same interface as EDC sites
  • Offers users customizable paper query templates
  • Enables ad hoc data queries with Web-based SQL editor

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