WU CONSULTING: WHY WE SERVE CLIENTS

At Wu Consulting, supporting a client in the process of obtaining FDA approval is one of the most rewarding services we offer. It’s a reflection of trust, partnership, and the incredible amount of hard work put into creating a product that can improve lives. As your outsourced biostatistics team, we’ve had the privilege of contributing to many FDA approvals across therapeutic areas such as oncology, rare diseases, and ophthalmology. But what does it actually mean to serve a client in the FDA process?

Biostatistics plays a central role in the journey to FDA approval. Starting with a trial design, through data analysis, and into final submission, we are deeply embedded in the strategy and execution of every step. Our work most usually begins with collaborating on the protocol and the Statistical Analysis Plan (SAP), ensuring that every aspect of the study is designed with statistical integrity and satisfies all regulatory expectations. As trials progress, we continue to support our clients with real-time monitoring, interim analyses, and adherence to ICH and CDISC standards, and most importantly with the end goal of submission-readiness in mind.

It is only after the study concludes, however, when the most difficult part of the process starts. And that is preparing a clean, defensible, and transparent statistical package for the FDA. Our team is responsible for generating every necessary component to tell the full story of the data. We also assist in the production of the statistical sections of the Clinical Study Report (CSR), support our clients in responding to regulatory questions, and refine documentation as needed. It is detailed work that requires not just technical skill, but also a deep understanding of how regulators think and what they’re looking for. With our employees averaging 15 years of experience, our firm provides these skills and knowledge.

For us, contributing to an FDA approval is a powerful validation of our expertise and commitment. Our history confirms that our strategies, analyses, and communication were not only correct, but also instrumental in helping our client cross the finish line. And perhaps most importantly, it means that we have played a part in moving a new therapy one step closer to patients who need it.
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Whether you’re preparing for a pivotal trial or just starting the regulatory conversation, Wu Consulting is here to help you navigate the complexity with confidence and turn great science into meaningful outcomes.