Clinical Research

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  • PCR Services

    Regulatory

    • Initial IRB Submission including consent forms and other required documents
    • Submit continuing reviews and modifications to IRB
    • IRB document maintenance
    • Negotiate with and serve as liaison between sponsors and IRB
    • Regulatory document management
    • Submit supplements and amendments to update registered product information
    • File and maintain correspondence with site and sponsor
    • Complete and email regulatory documents such as copies of medical licenses, CVs, etc to sponsors
    • Coordinate site initiation visits
    • Process confidentiality agreements and contracts
    • Manage study accounts
    • Assist with grant writing and manuscript preparation

    Financial

    • Negotiate industry sponsored budget and start-up costs
    • Detailed financial reports
    • Financial tracking and billing
    • Billing Schedule, Research Rates, Industrial Account set-up
    • Submit invoices and reimbursements requisitions

    Study coordination

    • Attend investigator meetings and teleconferences
    • Review protocols
    • Assess feasibility and patient population available for trial
    • Pharmacy Interface
    • Case report form completion ( paper and electronic)
    • Supervise monitoring visits
    • Onsite study recruitment, screening and enrollment
    • Collection, entry and maintenance of study data
    • Study close out and archives
    • Study recruitment and screening
    • Develop source documents and study specific SOPs
    • Process regulatory documents for study
    • Respond to queries
    • Coordinate and supervise Compliance and FDA audits
    • Provide in-services on study procedures
    • Maintain appropriate temperature logs

    Routine research nursing services

    • Patient monitoring
    • Phlebotomy
    • Infusion studies
    • Pharmacokinetic studies
    • Anthropometric measurements
    • Urine collection studies
    • ECGs performed
    • Specimen processing, storage, and specimen shipping
    • Specimen retrieval from within the hospital
    • Custom labeling
    • Anthropometric measurements including skin-folds, BMI, etc.
    • Metabolic testing (resting metabolic rate) and Pulmonary function testing
    • Exercise stress testing (cycle ergometer or treadmill)
    • Muscle function testing
    • Bone densitometry
    • Advanced Cardiac Life Support
    • Monitoring of patients