Category: Project Optimus

Enhancing Oncology Outcomes: Project Optimus and the Future of Oncology Drug Development

When the U.S. Food and Drug Administration first introduced Project Optimus, it marked a decisive shift in how oncology drugs are developed. Several years on, its impact is no longer theoretical; it is actively reshaping dose optimisation and trial design. For sponsors and CROs alike, understanding how to operationalise this initiative is now critical. What…

May 20, 2026

About Us

Simbec-Orion is an experienced, technology-enabled, global Contract Research Organisation (CRO) specialising in Clinical Pharmacology, Oncology, and Rare Diseases, with offices across the UK, Europe, the United States and Asia-Pacific. Established for almost 50 years, we provide clinical trial expertise to a wide range of small to mid-sized biotech and pharmaceutical partners around the world.

Across the organisation, scientific teams leverage both a wide therapeutic experience in clinical pharmacology, as well as more specialist expertise in Phase I-IV oncology and rare disease. Simbec-Orion’s adaptable, highly experienced teams continuously take a quality-first approach, whilst maintaining the short communication lines and Senior Leadership Team oversight only achievable with a lean management structure.