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