Caidya has announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution.
The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programmes to scale while maintaining focus, speed and accountability.
The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies.
With established operations across Europe, the Americas, APAC and China, the combined organisation provides meaningful expertise and execution capabilities in the regions that matter most.
Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later-stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organisations strengthen their ability to support complex cross-border programmes while providing a more connected path from First-in-Human studies, both in healthy volunteers and patients, through registration.
The result is broader capabilities, deeper expertise and greater continuity – delivered with the responsiveness, accountability and close collaboration that clients expect from a specialist CRO.
With long-established operations across Europe and nearly five decades of experience supporting innovative biopharma companies, Simbec-Orion has built a reputation for helping sponsors navigate some of the industry’s most complex development challenges.
The organisation brings specialized expertise in clinical pharmacology, oncology and rare disease, spanning Phase I through Phase III trials, supported by a strong European footprint and trusted relationships across the biotech ecosystem.
The combination includes Simbec-Orion’s 48-bed Phase I clinical pharmacology unit, one of Europe’s leading early-phase facilities, giving sponsors a continuous path from First-in-Human studies through registration that preserves knowledge, accountability and momentum at every stage.
“We are thrilled to bring together the Simbec-Orion and Caidya teams,” said Barbara Lopez Kunz, Chief Executive Officer, Caidya. “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.”
“We are pleased to be joining forces with Caidya – which shares so much of our common culture,” said Fabrice Chartier, Chief Executive Officer, Simbec-Orion. “Our combined organization creates a CRO that combines the intimacy of a specialist partner with the reach of a global development organization to meet the needs of modern drug development. Together, we will enhance our combined geographic footprint, benefiting Simbec-Orion with enhanced access to the US and Asian markets and Caidya with greater presence in Europe and in Phase I clinical pharmacology. We are extremely excited to partner with Caidya to create a more complete partner for innovators.”
“Simbec-Orion has built a reputation for excellence in clinical research, particularly in navigating the complexities of early-phase development and European regulatory environments,” said Dr. Lingshi Tan, Executive Chairman of the Board, Caidya. “By integrating their expertise with Caidya’s global reach and deep therapeutic experience, we are uniquely positioned to support the growing trend of cross-border biopharma innovation, particularly the dual-direction flow of therapies among the US, Europe and Asia.”
“CBPE has been proud to support significant investment in people and the Digital Transformation of Simbec-Orion, enabling strong growth since 2019. We are confident that joining forces with Caidya represents the ideal next chapter for the business, its people and its clients,” said Anand Jain, Partner, CBPE and Chairman, Simbec-Orion. “By combining aligned cultures with a more connected development model, sponsors gain a continuous path from First-in-Human through to registration without changing the experienced partner they trust.”
