Strategic and Hands-On Support Across Clinical Operations and Development Functions

Cambridge Biopharma Solutions provides fit-for-purpose consulting for biopharmaceutical companies seeking flexible, senior-level expertise in clinical operations, development operations, and clinical compliance. All client engagements are led by the firm’s founder, with delivery coordinated through a trusted network of experienced consultants when broader support is required.

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We specialize in helping clients who need:

  • Operational leadership without permanent headcount - Interim functional oversight, trial governance, and day-to-day management during growth, turnover, or transformation.
  • Cross-functional alignment and execution - Embedded support across multiple functions to ensure program continuity, strategic alignment, and vendor integration.
  • Support for lean or fast-moving teams - Senior-level guidance for small or emerging biotechs navigating time-sensitive development milestones or evolving trial needs.
  • Governance, clinical compliance, and inspection readiness - Development of trial oversight frameworks, vendor accountability structures, and operational risk mitigation plans.
  • Clinical operations strategy and optimization - From trial feasibility to vendor contracting, CRO management, and ongoing site engagement strategies.

When broader expertise or capacity is required, Cambridge Biopharma Solutions engages experienced consultants—each vetted for functional depth and executional excellence. These collaborators may support areas such as data management, biostatistics, clinical compliance, medical writing oversight, and more.

Ready to explore support options?

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