serviceEDC-enabled Data Management

Highly professional data managers provide flexible and high-quality service in an expeditious manner.

We 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 generated. Through 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
Point 3.
IT-driven data management approach, e.g. EDC

Main Services and Details

GCP

We prepare the following:

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

PMS

We prepare the following:

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

Lineup of GCP-EDC services

  • DATATRAK ONE
  • Rave
  • Viedoc

Lineup of PMS-EDC services

  • ADDIN
  • Viedoc
  • PostMaNet
  • Rave

Message from Data Management Staff

Shortly after joining Asklep, I had the opportunity to experience the entire operation of PMS-data management in hyperlipidemia. Shortly after, I joined a new project at one of our client pharmaceutical companies and was responsible for their entire PMS operation. Although I had had thorough experience in data management, I was anxious with high expectations of carrying out the operation from a pharmaceutical perspective.
Through this experience, I realized that pharmaceutical companies consider the CRO as “professionals in PMS”. We are often asked for our opinions and advice concerning procedures and handling the operation. We therefore need to have a complete overview of the entire project, not merely individual processes, and be able to make decisions from the same perspective as the pharmaceutical industry.
I strive to contribute to the quality of surveillance with a broad, comprehensive approach in collaboration with pharmaceutical companies.

K.S. has 6 years of experience in data management

Staff photo

ADDIN EX

Our EDC System provides speed,low cost and high quality

For more details

For further information onINTAGE Healthcare Inc., click here:

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

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