Consulting & Strategic Planning

Whether you’re developing a drug, a biologic or a medical device, and planning a small study or a large multinational program, Health Decisions will customize a consulting program specific to each sponsors' goals. Our senior staff will explore which adaptive techniques are applicable and the benefits, limitations and net effect on the program in the context of the sponsor’s business objectives, funding, philosophy and capabilities.

Drugs

All phases from safety through confirmatory and postmarketing

  • Protocol Development
  • Phase I Safety Testing
  • Proof of Concept
  • Dose Selection
  • Confirmatory Testing

Medical Devices

Diagnostic, therapeutic and surgical devices
Class II and Class III, 510(k) or PMA

  • Protocol Development
  • Device Classification and Exemptions
  • Premarket Approval for Class III Devices
  • Premarket Notification (510K) to establish Substantial Equivalence to a legally marketed device

Consulting Services

Health Decisions' consulting services focus on two key areas of a trial:

Protocol Design

  • Measuring value: investment considerations, Net Present Value (NPV), Internal Rate of Return (IRR); influence of time and cost elements
  • What adaptive design techniques will achieve and what they will not achieve
  • Assessing which elements are suitable for the sponsor, the program and the study, measured by IRR and NPV
  • Study risk reduction: early recognition of weakness, eliminating all-or-nothing chance of failure
  • Statistical and operational considerations as they affect design
  • Regulatory strategy
  • Preparation and development of study plan and protocol

Operational Considerations

  • Adaptive operations: enrollment, quality measures, monitoring and more
  • The effects of outsourcing operational components
  • Number of sites vs. speed, geographic location
  • Internal and external study teams—oversight, quality indicators, streaming performance metrics