EDC Solution

EDC (Electronic Data Capture) is a highly efficient web-based system having functionality for entering and collecting data that is to be used when conducting a study. EDC can of course be used as a hybrid system should paper be required at the sites for the post-marketing study.

The EDC system developed by ASKLEP makes the best use of EDC and ensures the smooth operation of the trial.

Features of ASKLEP EDC

  • Operability of screens in which physicians enter data
  • Ease of use entry screens that are comprehensible to participating physicians. This basic necessity is a must for any PMS-EDC system.
  • Centralized management of databases
  • Other EDC systems may need to transport data to another database for coding or secondary logical checks. The EDC system developed by ASKLEP consistently works in a centralized environment and need not be validated for compatibility with other databases.
  • Data management function
  • The following data management function in place to enable the management of heavy data required for PMS studies:
    1. Coding (disease name, drug name, adverse event)
    2. Logical checks (secondary logical)
    3. Data clarification form preparation function (with draft template files)
    4. Task management for data management activities (progress management function)
    5. Study progress management function (progress management log)
  • Data Trail management function
  • Historic data or data trail is managed from the initially transmitted data entered by a physician to final database lock. Data can be searched to find screens and check them, as well as the output.
  • Updating study specifications and version
  • PMS is expected to have the survey amendments and logical check specifications updated during a study. The EDC system developed by ASKLEP can update the specifications without suspending the study and reflect those changes immediately.
  • E-mail function
  • Email is integrated into the system to ensure smooth communication throughout the study.
  • Integrated electronic signatures (Optional function)

WEB Progress Management System

This is an ASP web progress management system for the centralization of progress status for post-marketing studies. The use of this progress management system allows MRs out in the field and management functions to share the progress status of a study. Furthermore, the function of division specific progress management is available for up to three layers (such as “area”, “district office” and “sales office”). This provides flexible support function for your management and sales activities.

 

The use of our EDC will assure you of seamless data links that will make the progress management of your trials more efficient.