Clinical
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Clinical Planning and Strategy (pre-market, post-approval and post-market studies)
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Develop strategies and plans for product approval
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Clinical trial design for pre-market trials
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Protocol development for clinical trials
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Pre-submission support and interaction with regulatory agencies
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Post-approval/continue access study design
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Post-market registries design
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Clinical Operations
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Design framework for clinical operations
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Create protocol templates per regulatory agencies
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Develop clinical study plans (Project Plan, Monitoring Plan, Timelines and Milestones)
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Develop clinical study regulatory documentation for US and OUS (Informed Consent - ICF Templates, Patient Recruitment documentation, other study required documents and study tools)
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Develop clinical program budget forecasting and tracking tools
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Clinical Trial Management
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Develop trial regulatory documents
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Establish trial management tools
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Develop site evaluation/qualification, start-up and activation tools and documents
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Develop site activation approval documentation and process
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Create study documentation for IRB and regulatory agencies approval
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Site management, monitoring and oversight
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Oversight of study shipment and tracking
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Medical Monitor, CEC and DSMB management
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Develop site payment and tracking tools
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Develop Trial Master File (TMF) structure, required documents and systems
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Clinical Trial Investigator Meetings
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Vendor Selection and Management
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Develop Scope of Work for vendor bid
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Develop bid evaluation tools
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Develop cost-effective management for multiple trials
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Develop vendor management tools
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Data Management
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Establish Electronic Data Capture system
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Database Vendor identification and qualification
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Establish clinical trial data collection tools
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Develop and review case report forms
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Establish the data validation, query resolution and cleaning processes during study, for interim and final database lock
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Integration with other existing other systems and processes
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Reconciliation of external data
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Establish enrollment and randomization systems study-specific
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Safety
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Support safety process development and implementation
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Support defining study specific Adverse Events (AEs), Serious Adverse Events (SAEs) and Unaticipated Adverse Device Effects (UADEs) definitions and reporting guidelines
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Create framework for tracking and reporting AEs/SAEs/UADEs
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Create event narrative templates
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Develop CEC and DSMB processes and manage event review
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AE/SAE/UADE review and trending
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