DDis flagship product mEDC has been selected by one of the top 20 pharmaceutical company (HQ in Germany) as its preferred EDC tool along with integrated CDM services.
As part of the multi-year contract signed during Q2 2014 by the global head of regional clinical operations (sponsor), all its subsidiaries/ regional affiliates and CRO partners will be using mEDC and integrated CDM services for all its late phase studies in various countries.
During the selection process, the sponsor has evaluated many e-Clinical vendors and CRO service providers; and eventually shortlisted few of them for the next level of scrutiny. The sponsor has visited DDi offices globally and its datacenter in USA to audit all its processes, standards, IT infrastructure and e-clinical tools.
DDi could impress the sponsor with its well defined SOPs & quality processes; adding high value by offering mEDC and CDM services in an integrated platform, thus proving it to be very robust and cost effective solution.
mEDC is a web based electronic data capture system that offers faster study setup, flexible configuration, detailed reporting, improved query management, all leading to enhanced user experience.
The Key Features are Key Features:
Core CDMS functionality: Study design, Set-up, Edit checks, Discrepancy management, Database lock and Archival
Detailed dashboard & reports
Built-in auto coding
Fully compliant with FDA 21 CFR Part 11 and GAMP 5
Create eCRF forms with ease without programming: An unique interface for stakeholders to design and create complex CRF forms easily.
Highly configurable and adaptable: To accommodate the best practices in clinical trials, and can be easily customized for any specific study phase or therapeutic area.
Run adaptive trials and implement protocol amendments quickly: Sponsors can now deploy all mid-study amendments without compromising study database integrity. mEDC manages multiple CRF editions and seamlessly migrate existing data into new forms and visit structures.
Rich, intuitive user interface: User friendly, easy navigation and rich graphical interface with robust features ensures high acceptance by the stakeholders. Increased data accuracy and reduced cleaning time: With sophisticated edit check programming and auto coding feature.
Seamless integration with third-party systems: Easily shared with other clinical systems like IWRS, IVRS, CTMS, ePRO and safety systems.
Lower total cost of ownership: Easy to install and set-up, and requires less programming/technical knowledge. With flexible deployment options and support services, mEDC is best ROI which truly reduces the clients total cost of ownership.