Caidya and Simbec-Orion Combine to Create Integrated Specialty CRO From First-in-Human Through Registration

• Caidya, a global specialty CRO headquartered in Raleigh, North Carolina, has announced a strategic combination with Simbec-Orion, a UK-headquartered CRO with over five decades of experience in clinical pharmacology, oncology, and rare disease — creating an integrated specialty clinical CRO platform spanning the Americas, Europe, APAC, and China with uninterrupted coverage from first-in-human studies through registration.

• The combination adds Simbec-Orion’s 48-bed Phase I clinical pharmacology unit — one of Europe’s leading early-phase facilities — and its established European regulatory and biotech relationships to Caidya’s existing global platform, giving sponsors a single CRO partner capable of maintaining scientific continuity, accountability, and momentum across the full development lifecycle.

Caidya, a global CRO specializing in the execution of complex clinical trials, announced on June 30, 2026, a strategic combination with Simbec-Orion, a UK-headquartered CRO with more than five decades of experience in clinical pharmacology, oncology, and rare disease. The transaction brings together two complementary specialty CRO organizations to create a more complete development partner for innovative biopharma companies, with the combined entity operating under the leadership of Barbara Lopez Kunz as CEO and Fabrice Chartier continuing to lead Simbec-Orion’s operations within the combined company.

The strategic rationale centers on closing a structural gap that has historically required sponsors to change CRO partners — and lose scientific continuity — as programs advance from first-in-human studies through Phase II/III and registration. Simbec-Orion contributes its 48-bed Phase I clinical pharmacology unit, one of Europe’s leading early-phase facilities, along with deep expertise in clinical pharmacology, complex oncology, and rare disease trials spanning Phase I through Phase III. Caidya contributes a global operating platform across the Americas, APAC, and China, with established capabilities in complex cross-border trial execution, multiple therapeutic areas, and regional regulatory strategy including China-specific development expertise. The combined CRO is designed to support innovative biopharma sponsors from first-in-human studies — in both healthy volunteers and patients — through to registration, maintaining a single accountable partner across the full development arc.

For biotech sponsors working across the U.S., Europe, and Asia simultaneously, the geographic complementarity of the combination is directly operational. Simbec-Orion’s long-established European footprint and trusted relationships within the European biotech and regulatory ecosystem address a gap in Caidya’s prior European presence, while Caidya’s U.S. and Asian market access — including deep China development expertise — expands Simbec-Orion’s reach for clients seeking to pursue dual-direction development programs. CBPE Capital, which has backed Simbec-Orion since 2019 and supported significant investment in the company’s people and digital infrastructure, cited the combination as the ideal next chapter for the business.

The combined organization reflects a broader trend in the specialty CRO market toward building integrated platforms that can deliver both the therapeutic depth and scientific intimacy of a specialist partner alongside the geographic reach and operational infrastructure associated with larger CRO organizations — without the loss of accountability or program continuity that can accompany transitions between vendors at different development phases. Edgemont acted as exclusive financial advisor to Caidya, with Sidley Austin serving as legal counsel. Stifel acted as financial advisor to Simbec-Orion and CBPE, with Eversheds Sutherland serving as legal counsel.

“This strategic combination brings together complementary strengths to create a more complete development partner for innovators. By combining Simbec-Orion’s European presence and early-phase expertise with Caidya’s global platform, we can support sponsors from first-in-human through registration while helping them thrive where development becomes most difficult: at the intersection of scientific innovation, operational complexity, and global clinical execution.”

Barbara Lopez Kunz, Chief Executive Officer, Caidya