eClinical Trials : EDC

Provide total support service to the EDC application test by experienced staff, handling possibility to EDC system such as Rave™ and InForm™ and EDC (Electronic Data Capture) application and operation to the multinational collaborative study (Asian Study) We can offer qualified personnel to support EDC operations fully. Flexible to operate any EDC Systems, such as Rave™ and InForm™.

 

CMIC's Edge in eClinical Trials

Introductory support based on the business experience as CRO
Our staff with expertise in datamanagement and/or EDC provide accurate and prompt services.
Clinical support based on CMIC Group expertise
Achieve reduction of total-lead-time by total support from registration, to data management and total analysis.
 
Service from specialized staff
Career staff knowledgeable in data management, monitoring, IT, and quality control, conduct the work. By using the know-how accumulated in the past, we support the total work from set-up to operation of EDC system used globally.
 
Handling any work regarding EDC
In facing the difficulties of development planning because of lack of human resource, we control EDC according to clients' procedure, and are able to provide human resource to conduct DM work for each testing.
 
Highest level of partner program accreditation with Define.xml, Reviewer's Guide ASPire to Win
Enhanced EDC services provided through strong collaboration with Medidata Solutions
CDISC Compliance(SDTM)
Experience in creating SAS datasets in SDTM format

Our Services

  • Prepare Data Management Plan and Procedure
  • Prepare screen layout of eCRF and support building system
  • Building and engineering specification system for DVS (Dynamic Form, Derivation, Edit check)
  • Prepare data entering manual
  • Offer training program
  • User management
  • Project Management
  • Manual checking
  • Query management (preparing, issuing, and closing)
  • Managing external and imported data (confirm routinely)
  • Transferring Integrate and Confirm date of e-Data, e-Diary, IVRS, and EDC to Central Lab
  • Coding Support for Safety Information and Pharmaceutical Information collected by EDC
  • Collecting Safety-Information Database
  • Preparation of DM Report
  • CDISC Compliance
  • SDTM data conversion (including mapping specifications)

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Inquiries about our services

Click here if you are interested in outsourcing your operations to us.

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