CLINICAL OPERATIONS SERVICES

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DEVUM Research has excellent management professionals with intense clinical trial experience which satisfy need of sponsors, CRO and Investigators to manage clinical trials. We provide detail oriented services at every level of clinical research including documentations, regulatory, IRB, execution of trials and statistical analysis. We have professionals with global clinical research experience, which makes us compatible for managing multinational clinical trials. Devum Research provides smooth site management services to conduct hassle free trials for investigators. Highlights of our clinical operation services for sponsor, CRO and Investigators:

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  • Investigator Support

    Investigator Site Setup:
    Site specific SOP design
    Staff Training
    Feasibility assessment
    IEC/IRB submission and follow up
    Site set up and infrastructure development
    Contract and Budget Submission
    Identify and manage support service vendors

    Study Startup:
    Regulatory Submission
    CRF design
    Study specific protocol training

    Study Maintenance:
    Patient recruitment strategies
    Trial Master File
    Study specific procedures
    Safety Reporting
    Maintain and Update EDC
    Maintain IVRS, IWRS and CTMS
    Site Monitoring
    Lab and Pharmacy Management

    Study Closeout:
    Queries Resolution
    Study Document Archiving
    Coordinate site close-out visits
    Final budget follow up

    Sponsor/CRO Support

    Regulatory Submission
    Feasibility
    Site Selection
    Site Monitoring
    Medical Monitoring
    Site Audits
    Clinical Trial Management
    Training Design
    Recruitment and Retention Services
    Research Meetings Organization