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.

Allucent Consulting™ services include, but are not limited to: