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Featured Case Studies

Insight-driven and inventively bold, we excel in building strategies and developing highly customized programs. Our experience—from custom-designed clinical research studies to FDA registration and approval to commercialization—allows us to establish the best path to optimal outcomes.

Patient-Centric Approach and FDA Expertise Lead to Orphan Approval

By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.

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“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of…

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Multidisciplinary Team Advances Immuno-Oncology Development
Date: July 24, 2020 Author: Ruth Stevens, PhD, MBA Project Lead: Stacey Ayres, PhD In...

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Combination Product Expertise and Target Market Knowledge Create Commercial Success

By identifying the proper product category, we worked with an international company to correctly reposition its drug-device combination product for FDA approval and drive market penetration.

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Real World Evidence Saves Project

When a biotech company could not afford the time and expense to conduct intended studies, we stepped in and quickly and creatively turned things around with the FDA.

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Rapid Nonclinical Planning and Coordination Keep Post-Marketing Requirements on Track

After a biotech company received paper NDA approval for their drug, Camargo contributed to successful commercialization, planning and executing Phase 4 post-marketing requirements with a short timeline.

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Strategic Submission Preparation Redefines Product Value

With strategic submission support, a biotech company gained approval for an improved delivery technology of an already-approved drug, setting the potential to become a new “gold standard” treatment in oncology.

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