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In order to gain FDA (Food & Drug Administration) approval, the sponsor entrusted Keyrus Life Science to conduct the pilot for this drug. Because of the Partnership built on the pilot with the sponsor, they chose Keyrus Life Science as their partner on the follow-up study.
Lack of the sponsor's knowledge of the product in the US Marketplace and time deadlines.
Keyrus Life Science took lessons learned from the pilot to run full service for the study and preparation for FDA submission.
Having learned from the pilot, and having built a strong partnership, the sponsor believed Keyrus Life Science was the best CRO to manage their expanded study to gain FDA approval. The Loteprednol drug was approved in the US.
What our clients say
We developed a dynamic and trusted partnership model where Keyrus’ team was an expert extension of our clinical development team. I would work with Keyrus again with my most critical studies
Yves G. Leblanc, Ph,D., Director of operations, Sandoz