serviceEDC-enabled Data Management

Highly professional and capable data managers provide high-quality services in an expeditious manner.

We plan and implement data management projects in full compliance with GCP and GPSP with a particular focus on the validity of and consistency in the enormous amount of data. Through our thorough quality control, we provide high-quality data from the beginning to the end of all projects.

Overview of EDC Services

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Service Features

Point 1.
GCP, GPSP and regulation-compliant DM
Point 2.
High-quality and consistent service delivered by highly-skilled professionals with experience
Point 3.
IT-driven data management approach, e.g. EDC

Main Services with Details

GCP

We prepare the following draft documents:

  • CRF
  • Data management operating procedure (plans)
  • Data base design and development, entry system
  • CRF checklist (reexamination requirements)
  • Logic check specifications
  • Logic check program
  • Data entry and corrections, coding
  • CRF check (logic and manual), reexamination request (queries)
  • Clinical conference materials
  • EDC system setup
  • System validation
  • Data management operating reports

PMS

We prepare the following draft documents:

  • Data management operating procedure (plans)
  • Data base design and development, entry system
  • CRF checklist (reexamination requirements)
  • Logic check specifications
  • Logic check program
  • Data entry and corrections, coding
  • CRF check (logic and manual), reexamination request (queries)
  • AEs data matching
  • Coding data maintenance
  • System validation
  • Data management operating reports
  • On-site data management service
  • Data managers dispatch

ADDIN EX(EDC system for post-marketing surveillance)

Our EDC System with speed, low cost and high-quality has been released

For more details

For further information onINTAGE Healthcare Inc.

If you have any questions or comments, please do not hesitate to contact us.

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INTAGE Healthcare’s Scope of Service