MakroCare selected for iDOT by a fast growing US Pharma Client

Top Quote In pursuit of providing high quality and cost effective integrated solutions to the clients through its iDOT (integrate Data Operations & Technology), MakroCare has signed another contract to provide clinical data management, biostatistics services integrated with eClincial tools (mEDC, mIRT) from it's Tech subsidiary DDi, for a Phase II study involving around 300 patients in US. End Quote
  • Newark, NJ (1888PressRelease) April 09, 2015 - With this contract, many more US investigational study sites will get opportunity to use simple, user-friendly but robust electronic data capture system (mEDC) and randomization tool (mIRT).

    MakroCare's integrated data operations & technology solution is a strategic approach towards delivering standardized services and technology in integrated manner to reduce costs for sponsors. This one stop integrated solution with study specific customized approach offers clients increased productivity, higher flexibility and lower oversight in cost-efficient manner.

    What is iDOT?
    MakroCare's iDOT is a strategic approach towards delivering standardized services and technology in an integrated manner. Defining the right parameters / scope of the service and developing the right combination of 'end to end process, teams and tools' are the key activities that drive best value to customers.

    Services
    Centralized project management
    Metrics driven data management
    Study setup programming aligned
    Standardized global SOPs
    Focused teams by TA & by Interventional/Observational

    Technologies
    DDi, the technology subsidiary of MakroCare provides the products & technology for iDOT. DDi has built its technology competency with a unique blend of technical and domain expertise.

    -DDi Products
    -mEDC
    -mIRT
    -mPortal
    -DDi Solutions
    -Clinmetanoi(Analytics)
    -Tula(Risk & Compliance Management)

    Advantages
    Single sign-on interface for all tools
    Highly adoptable and scalable
    Fully compliant with FDA 21 CFR Part 11 and GAMP5
    Data hosted in USA (SSAE 16 Certified Data Centers)
    Reduced study demand variation risk
    Reduced technology risk

    Why iDOT
    Single vendor concept - common standards, higher accountability & easy to add/drop services & studies
    High ROI with lower cost, sponsor oversight time saving & less hand offs
    Smarter delivery models
    Quick implementation and 24x7 global supports
    No third party licensing and maintenance costs
    Global experienced teams
    Global client base
    ITIC Certified service management

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