MakroCare to introduce new version of mEDC for clinical research
DDi (Drug Development Informatics), an IT division of MakroCare provides complete clinical informatics and IT solutions to the pharmaceuticals, biotechnology and medical device companies. DDi is all set to release the new version of “mEDC v2.0” soon. “mEDC v2.0” is a highly comprehensive configurable web-based electronic data capture application used for managing single or multi-site clinical research studies with complete audit trail within a centralized database.
It incorporates advanced medical auto-coding feature and medical dictionaries like: MedDRA, WHOdrug etc. The earlier version “mEDC v1.0” was launched in 2009.
“mEDC v2.0” provides core CDMS functionalities like Study design & Set-up, Edit checks, Discrepancy management, Database Lock and Archival, single / double data entry, intuitive role-based views and displays, supports hybrid studies (both paper CRF and eCRF), data exports to SAS, CDISC, Excel formats, English and Japanese language support.
“mEDC v2.0” is a much friendlier user interface, and easy to navigate through the system and the product has been validated as per FDA 21 CFR Part 11, GMP and GAMP 5 guidelines.