Clinical

  • Clinical Planning and Strategy (pre-market, post-approval and post-market studies)

    • Develop strategies and plans for product approval

    • Clinical trial design for pre-market trials

    • Protocol development for clinical trials 

    • Pre-submission support and interaction with regulatory agencies

    • Post-approval/continue access study design

    • Post-market registries design

  • Clinical Operations

    • Design framework for clinical operations

    • Create protocol templates per regulatory agencies

    • Develop clinical study plans (Project Plan, Monitoring Plan, Timelines and Milestones)

    • Develop clinical study regulatory documentation for US and OUS (Informed Consent - ICF Templates, Patient Recruitment documentation, other study required documents and study tools)

    • Develop clinical program budget forecasting and tracking tools

  • Clinical Trial Management

    • Develop trial regulatory documents

    • Establish trial management tools

    • Develop site evaluation/qualification, start-up and activation tools and documents

    • Develop site activation approval documentation and process

    • Create study documentation for IRB and regulatory agencies approval

    • Site management, monitoring and oversight

    • Oversight of study shipment and tracking

    • Medical Monitor, CEC and DSMB management

    • Develop site payment and tracking tools

    • Develop Trial Master File (TMF) structure, required documents and systems

    • Clinical Trial Investigator Meetings

  • Vendor Selection and Management

    • Develop Scope of Work for vendor bid

    • Develop bid evaluation tools

    • Develop cost-effective management for multiple trials

    • Develop vendor management tools

  • Data Management

    • Establish Electronic Data Capture system

    • Database Vendor identification and qualification

    • Establish clinical trial data collection tools

    • Develop and review case report forms

    • Establish the data validation, query resolution and cleaning processes during study, for interim and final database lock

    • Integration with other existing other systems and processes

    • Reconciliation of external data

    • Establish enrollment and randomization systems study-specific

  • Safety

    • Support safety process development and implementation

    • Support defining study specific Adverse Events (AEs), Serious Adverse Events (SAEs) and Unaticipated Adverse Device Effects (UADEs) definitions and reporting guidelines

    • Create framework for tracking and reporting AEs/SAEs/UADEs

    • Create event narrative templates

    • Develop CEC and DSMB processes and manage event review

    • AE/SAE/UADE review and trending