Helen Ofoche

Clinical Trial Disclosure and Transparency at Independent

Speaker

Helen Ofoche is an experienced SME within the Clinical Trial Disclosure and Transparency (D&T) space. She has proven successful in developing D&T programs and navigating clients and organizations to reach compliance. Helen has managed D&T efforts at Jazz Pharmaceuticals, Daiichi Sankyo, and other pharmaceutical/biotechnology companies. Prior to Pharma, she began her career in academic clinical research at Johns Hopkins University and Drexel University.

In her capacity, Helen has implemented and modernized programs across the full spectrum of D&T, including, but not limited to, global clinical trial registries, redaction/anonymization (Health Canada PRCI, EU CTR, Policy 0070), plain language summaries, and external trial data sharing.

As a Drug Information Association (DIA) member and as part of the overarching Clinical Trial Disclosure community, she keeps a pulse on the changing regulatory landscape. With a keen focus on policy updates within North America (US & Canada), the European Union, the United Kingdom, and Japan.