1
Remote Clinical Trial Support
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Remote clinical trial monitoring and oversight aligned with GCP and ICH E6(R3)
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Trial initiation activities, including site qualification and startup
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Trial closeout, database lock support, and final reporting
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Clinical data management, query resolution, and data integrity oversight
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Patient recruitment and retention strategy
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eTMF setup, guidance, and ongoing maintenance
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Vendor and CRO oversight for sponsors managing outsourced trials
2
Clinical Trial Documentation
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Protocol development, amendments, and synopsis writing
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Case Report Forms (CRFs) and CRF completion guidelines
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Investigator Brochures and updates
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Clinical study reports (CSRs) aligned with ICH E3
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Clinical Trial Applications (CTAs) and IND/IDE submissions
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Informed Consent Form (ICF) development and translation oversight
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Patient recruitment and marketing material review
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IRB, IEC, and Ethics Committee submission support
3
Trial Management
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Site selection, qualification, and ongoing site management
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Enrollment strategy and recruitment planning
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Telephone screenings and pre-screening support
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Risk-based monitoring planning and execution
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Protocol deviation tracking, reporting, and resolution
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Safety reporting and pharmacovigilance coordination
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Sponsor reporting, dashboards, and stakeholder communications
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Inspection readiness and audit support
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