serviceADDIN Series

ADDIN

Unique In-house EDC System Exclusively for PMS

INTAGE Healthcare, a pioneer among Japanese CROs providing postmarketing surveillance service, has been of service to the PMS projects of many pharmaceutical companies from the time GPMSP was first introduced in 1997. We are proud to report that we successfully launched our “ADDIN” EDC System Solutions on the market in 2010, made possible by the expertise and know-how we obtained through the process of in-house development and the operation of our data management system specializing in post-marketing surveillance. ADDIN ensures efficient, reliable and high-quality data collection for your PMS operation.

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Service Features

Point 1.
User-friendly EDC screen reduces the workload for Medical Doctors
Point 2.
Wide variety of Data Management functions and efficient processing
Point 3.
Full CRO support for pharmaceutical company operations

Wide Variety of Data Interactions

  • ADDIN has the following data management functions to manage large amounts of data management for PMS
    1. Coding (disease, drug name, adverse event)
    2. Logical Check (Secondary logical)
    3. Reexamination Request Form preparation (including dictionary files)
    4. Data Management Task Control (including progress follow-up function)
    5. Survey Progress Check (including progress charts)

Email Transmission Function

  • The messaging function in ADDIN supports smooth and reliable delivery of survey/resurvey requests via email.

Record Tracking Functions (Audit Trail Functions)

  • ADDIN manages data from initial data entry by medical doctors to the final lock. The recorded data is searchable for confirmation and output.

Survey Specification Changes and Version Upgrades

  • Changes in survey items and logical check specifications often occur during PMS; however, with the ADDIN system, such specifications and content changes are possible without suspension of the survey.

Electronic Signature Function

  • The messaging function in ADDIN supports smooth and reliable delivery of survey/resurvey requests by emails.

ADDIN EX

All Post-marketing Surveillance is Possible with Our EDC

“On-site” PMS-EDC System Goes Beyond Clients’ Expectations

ADDIN EX was developed based on over ten years of experience INTAGE Healthcare has acquired since the first release of ADDIN in 2004.
ADDIN EX is an essential tool for all types of post-marketing surveillance including “hybrid surveys”, “small scale surveys” and “all-patient surveys”.
Our EDC system assures smooth operation at every stage from EDC setup through PMDA applications.

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Our EDC System provides speed, low cost and high quality

  • Service Feature 1

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    Speed

    Initial stage of the system can be developed and set up within 3 months

    We assure a quick delivery of the system by tapping into our accumulated knowhow of surveillance and offer various templates to suit your surveillance.

  • Service Feature 2

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    Cost

    Reduced costs with enhanced efficiency

    We offer flexible pricing for our EDC system and customers can choose paper-based EDC and/or small scale surveys.

  • Service Feature 3

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    Quality

    Stress-free EDC functional specifications

    We accommodate all types of surveys including all-patient surveillance and CRF changes using our enhanced system with a PMS management function.

Self-learning EDC System

We assure our customers will enjoy the user-friendly EDC system with its vast number of CRF templates with easy customization tools

  • STEP 1

    Create a basic EDC from a complete set of templates

    Our one-stop CRO service provides full support for constructing systems

  • STEP 2

    Customize and develop add-on CRF for surveys for use with a non-basic EDC

    The customized CRF is archived as a template and readily retrievable for future use

  • STEP 3

    Construct entire EDC smoothly

    Our EDC system assures smooth operation at every stage from EDC setup through PMDA applications.

ADDIN.SCOPE（Progress Follow-up System）

Smooth implementation of Post-marketing Surveillance with our PMS platform

ADDIN.SCOPE is our web-based progress follow-up systems available via the internet. Using our system as your PMS platform provides smooth and reliable implementation of surveys from its ability for diverse data interactions. We offer a system best suited to satisfy the needs of our customers.
With ADDIN.SCOPE, the progress transition and passing ratio are checked by the department and visualized from the beginning of a survey.

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Service Features

Point 1.
Cloud-type, web-based progress follow-up system with very little investment
Point 2.
Diverse data interactions and less stressful progress follow-up from the most effective use of EDC / CDMS data
Point 3.
User-friendly screens designed with simplicity. Quick and easy information sharing function is also available.

Diverse Data Interactions

  • Pharmaceutical Companies : CDMS, EDC system
  • INTAGE Healthcare: ADDIN, EDC system, CDMS
  • Other CROs: EDC system, CDMS
  • Data output from CSV files and progress data imports are conducted every day.

Optional Functions

  • My Page
  • Contracts information entry
  • Fees management
  • Tallying alert by department

Standard Functions

  • Progress follow-up by patient, contract, and department
  • Graph display (progress by month and department)
  • Excel output
  • Contract information interface
  • EDC (ADDIN) survey information interface
  • In-house and external EDC survey information interface
  • Paper-based survey information interface
  • Paper-based survey and CRF tracking (including receiving date)
  • Multiple CRO capability (direct data uploads from CROs)

INTAGE TECHNOSPHERE, member of the Intage Group, offers POSTIER®/PMS a cloud based Progress Follow-up System for Post-Marketing Surveillance.

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