CMIC, more than CRO Our Performance

Clinical DevelopmentClinical Development

EDC Solution

Making the Move to Electronic Data Capture

  • CMIC offers varios services related EDC system for companies running clinical trials in Japan and/or worldwide.
  • CMIC's services and supports are comprehensive ----- with CMIC, you can have validated systems[2] for your own needs, and more ----- you can accelerate EDC-based clinical productivity across improved strategies and work flows including data management planning.

CMIC's EDC-enabled Comprehensive Services Feature:

(1)As an experienced Clinical Research Organization, CMIC can help and support you with:

  • The designing of eCRFs[3] because of our field-proven experience in clinical data management.
  • The creating of work flows, operating procedures and manuals when you've decided to make the transition to EDC.

(2)You can benefit significantly from our consolidated strengths ----- the CMIC Group offers you seamless support taking the full advantage of our expertise and knowledge of all that is needed to efficiently carry out clinical trials as CRO.

  • You can significantly reduce an overall lead time with CMIC's comprehensive support covering subject registration enrollment, data management and statistics analysis.
  • You can delegate data entry into eCRFs to our EDC-literate CRCs (clinical research coordinators) who function on a temporary-contract basis.
  • You can streamline SDV operations with CMIC's EDC-expert CRAs

We can support your EDC management comprehensively. Our professionals in every aspect of EDC management can help you, no matter what EDC system you are engaged in.
We can:

  • Develop DM protocols and Data Validation rules for EDC use and assist development of EDC-compliant SOPs and manuals
  • Do visual checks on data items not compatible with EDC automatic-checker function. And process queries that result from the visual checks process. (Query processing covers from data inputting to closing on an EDC system)
  • Do consecutive coding on what includes the names of illness, adverse event and medicine. And process queries that result from the data coding process. (Query processing covers from data inputting to closing on an EDC system)
  • Consecutively clean clinical data that are electronically received from a Central Clinical Laboratory; Process queries that result from the data cleaning process. (Query processing covers from data inputting to closing on an EDC system); and Import the processed data into EDC system
  • Import external data on tools like e-Diary into EDC system
  • Integrate EDC data with external data
  • Construct the analytical database and author the Data Management Report
  • Set up and operate help-desk functions

Contact

CMIC is very interested in hearing from you. Please feel free to send us your questions/comments at the following e-mail address. Our experienced staff will be happy to answer them.

E-Mail:e-solution@cmic.co.jp


References

  1. Electronic Data Capture:a Web-based system that collects clinical trial data electronically
  2. Validated system:a highly assured system that controls a process by which continuous production results from planned specification and quality of the product
  3. eCRF:an electronic case report form displayed on the web screenbrowser
Page Top