Clinical Strategy

Small and mid-sized enterprises often engage our clinical strategy team in the earliest stages of the drug development lifecycle, taking advantage of first-line consulting expertise to initiate evaluation and strategy dialogue. We help identify any issues or roadblocks and make corrections with the aim of expediting the path to approval, understanding how regulatory strategy and operational procedures interact. Working collaboratively across cross-functional disciplines, we engage biostatistics, medical experts, and operational leaders to create a robust design for each stage of development.

Our clinical strategy services span design and execution of full product development programs, from first-in-human studies through IND (or equivalent), clinical development, and marketing approval including Phase IV post-marketing research. Working with our team, you will find that we are approachable, responsive, and engaged, asking the right questions to prepare thoroughly to meet milestones and requirements. We have proven success in global markets across many different health products, including small molecules, biologics, vaccines, cell and gene therapies (including stem cells), nutraceuticals, medical foods, combination products, devices, and diagnostics.

Our services include, but are not limited to:

• Clinical development plans
• Clinical study reports (CSRs)
• Protocol design and optimization
  • Product portfolio strategy
  • Product development strategy and planning
  • Target Product Profile (TPP)
  • Program planning including statistical methods for go/no-go decisions, study design, and selected endpoints
  • Regulatory development strategy and submissions
  • Clinical pharmacology
  • Due diligence
  • Pediatric plans and orphan designations
  • Gap analysis, critical risk identification, and contingency planning
  • Health Authority meetings
  • Safety strategies and risk management
  • Pharmacovigilance