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i-CDMS®: The system that drives you to the future of clinical studies


i-CDMS® is an innovative information web based system offering a complete set of features for streamlining trial monitoring and data entry, discrepancy management and queries resolution, patient and site reporting. It provides a role-based clinical database management system that allows users access to the areas of functionality they are eligible to use. It supports electronic studies (e-CRFs) and offers full integration with other ancillary systems and statistical programs. The clinical database is established in CDMS according to the Data Management Plan (DMP) which is developed, including the annotated CRF, Data Entry Guidelines and Data Validation Plan (DVP) specifically for each study. i-CDMS provides status reports and audit trails, all accessible via the internet without any other special requirement or installation need at the site. i-CDMS system and provisioning service is fully compiant with GCP practices, 21 CFR Part 11 guidelines and Health Insurance Portability and Accountability Act (HIPAA) requirements.

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Case Study:

i-CDMS was used for a nationwide hybrid study (paper & electronic crf) with target of 6000 patients and 200 investigators from hospitals and private doctors. Study was completed according to schedule exceeding enrollment targets (~110% enrollment for e-CRF, 97% for paper CRF) and statistical analysis conducted successfully with the required dataset.


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