Consulting


Health Decisions will customize consulting services for your project or program to ensure that your clinical goals are met with minimal timelines and risk.

Whether you are developing a drug, a biologic or a medical device, whether planning a small study or a large multinational program, Health Decisions will customize a consulting program to ensure that your clinical development goals are met with minimal timelines and risk. Our senior staff will explore advanced designs, including whether any 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. Our success stories include numerous instances of enhancing studies and programs through adaptive design techniques such as seamless combined-phase designs, early termination for futility and sample-size reestimation. View the white paper, Ten Do’s and Don’ts of Adaptive Design.

Consulting and Planning for Biopharma and Devices

Drugs and Biologics

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

Focus of Clinical Consulting and Planning Services

Health Decisions’ consulting services focus on two key areas, protocol design and operational considerations for successful execution:

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