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July 7, 2023

FDA Comments Submission: Patient Focused Drug Development - Draft Guidance #4

We submitted comments to the US Food and Drug Administration regarding their draft guidance on Patient-Focused Drug Development (PFDD) and incorporating Clinical Outcome Assessments (COAs) into regulatory decision-making. Our comments addressed the FDA's concerns about implementing Goal Attainment Scaling (GAS) as a personalized endpoint in clinical development, and we shared our approach and tools to standardize GAS in clinical development.

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Based in Nova Scotia, our culture reflects an East Coast Canadian ethos rooted in hard work and collegiality.

With over a decade of experience partnering with multinational sponsors on cutting-edge patient-centric research, the impact of our work is global.

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