Expert Guidance for Planning Adaptive Programs

Adaptive methods offer an opportunity to better manage your research budget and reach milestones sooner, while reducing the risk inherent in drug development. Relying on 20 years of experience in planning and implementing adaptive programs, we’ll work with you to define your objectives and develop a program that reduces risk, cost and timelines. You will end up with a clearly written project plan and protocol that ensures the highest possible chance of success, regardless of who runs your study.

Key Considerations

Planning – Our team will define a range of design options based on your program goals, including statistical (Bayesian and traditional frequentist) and regulatory considerations. These initial discussions involve strategic and operational elements that typically include key stakeholders.

Simulations – Using Monte Carlo simulation and other techniques, we'll help you predict the most likely scenarios for clinical outcomes and supply chain issues, and show you how to incorporate these tools into your studies while in progress.

Infrastructure – We'll help you define IT requirements needed to make accurate, timely information available to specific study roles.

Regulatory – We work with you throughout, starting regulatory discussions as early as possible.  Our breadth of experience and clear understanding of uses and limitations of adaptive methods optimize interactions with key regulatory agencies such as the FDA and EMEA.

Biomarkers and Surrogate Markers – Our team will consider a range of intermediate markers, both to validate them for subsequent studies and for immediate decision making.

Avoiding Missteps – The emphasis throughout is on developing the necessary infrastructure and processes that allow you access to the information you need to make better decisions earlier.

For more information on results, view our Case Studies.

Learn How to Get Started

Our advisory sessions run from one day to several weeks or more, and can involve a single consultant or a team. Typically, we start with a limited engagement to outline the program or study, explore the means of improving speed and cost, and discuss how tradeoffs affect financial implications.

We know every set of circumstances is unique. To speak with us about your specific needs, or to learn more about our consulting services, please contact Rick Farris, COO at 919-967-1111 x245, or fill out our contact form.