SERVICES

    Introduction

    CenTRE offer services for administrative, regulatory and clinical aspects of the conduct of clinical trials.  This will help our clinicians to ensure that clinical trials are performed to the best standards of clinical research, maximizing the opportunity for patients to avail themselves of the most modern and innovative treatment approaches. Clinicians will also have the opportunities to perform linkages and networking with healthcare professionals across the world.
    Image

    Services

    Research Administration Advice Project Leader in applications for UiTM EC and MREC approvals
    Advice Project Leader in Research Project Budget Preparation/Negotation
    Assist Project Leader in reviewing and endorsement of Clinical Trial Agreement
    Advice Project Leader in research project registration in NMRR and IRES (UiTM)
    Advice Project Leader in applications for importing and exporting human tissues or any part thereof through the BLESS system
    Assist Project Leader in managing Research Grant
    Assist Project Leader in managing Research Assistants
    Advice Project Leader in completion and submission of the Annual Research Report to UiTM EC/MREC
    Assist Project Leader in archiving of Research Documents
    Research Activities Clinical Trial
    • Advice Project Leader in applications for Clinical Trial Import License (CTIL) approval
    • Coordinate Feasibility study process
    • Coordinate Site Initiation Visit
    • Monitor subject recruitment
    • Monitor research data entries to sponsor
    • Monitor the handling of research biological samples
    • Monitor the handling of Investigational Products
    • Monitor Study Close Out process
    Epidemiology
    • Coordinate Site Initiation Visit
    • Monitor subject recruitment
    • Monitor the handling of research biological samples
    • Monitor research data entries to sponsor
    • Monitor Research Adjudication process
    • Monitor Study Close Out process
    Trainings, Public Relations and linkages Coordinate trainings related to clinical and epidemiological research such as Good Clinical Practise Workshop and Study Coordinator Workshop
    Provide necessary consultation to new researchers
    Provides training to new research assistants
    Establish networks with research-related institutions such as Clinical Research Malaysia (CRM), Clinical Research Center(CRC), Institute for Health System Research(HSR) and Disease Control Division, MOH
    Establish linkages with Pharmaceutical and Clinical Research Organisation(CRO) companies locally and abroad
    Quality Control Provides training on data quality control such as Protocol Deviation Workshop, Verbal Autopsy Workshop and Data Management Workshop
    Perform 'Monitoring' on all sites for IIR on a regular basis
    Monitor Data Quality Control (QC)
    Monitor Safety Reporting(Adverse Event and Serious Adverse Event)
    Monitor Event Reporting
    Monitor PRotocol Deviation and Protocol Violation report
    Ensure assets/qequipment/inventory are calibrated on schedule
    Manage inventory of assets and equipment

    C.E.N.T.R.E Sg Buloh

    Centre For Translational Research and Epidemiology

    Level 4, Academic Building

    Faculty of Medicine, Sungai Buloh Campus

    Universiti Teknologi MARA

    47000 Sungai Buloh

    Selangor Darul Ehsan, Malaysia

    C.E.N.T.R.E Selayang

    Centre For Translational Research and Epidemiology

    Level 4, Clinical Building

    Faculty of Medicine, Selayang Campus

    Universiti Teknologi MARA

    68100 Batu Caves

    Selangor Darul Ehsan, Malaysia