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Clinical Strategy Development

Making the most of every piece of the regulatory puzzle.

Shoolin will provide you with the expertise in the strategic planning, design, optimization, and implementation of your adaptive design.

To embark on an adaptive design trial requires the ability to plan and communicate the design to the regulatory agencies then to communicate and execute the study with the investigational sites and overall project team. This is where Shoolin can help you.

Our experts will utilize trial simulations to recommend various adaptive design options according to the disease area and company portfolio. Develop the adaptive design protocol and outline the strategy for working with regulatory authorities. Execute the adaptive design including trial monitoring, interim analysis, and suggesting necessary adaptations. Provide analysis and interpretation of the adaptive trial data.

When it comes to clinical development, we’re dedicated to getting every moment right. And we have the people to get you there. The seasoned advisors on our Regulatory Consulting Services team have decades of experience helping teams interpret new and existing guidance throughout the process – and throughout the world. In fact, many of them are former FDA, EMA, and NMPA regulators themselves.

Our services include:

  • Regulatory Strategy
  • Health Authority Meetings
  • Quality system inspection
  • Submission support
  • Stakeholder Management
  • Mergers and Acquisitions

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