Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution

Caidya today 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 programs to scale, 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 organization 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 organizations strengthen their ability to support complex, cross-border programs 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 organization 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 of 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 of 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 U.S. 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 at 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 U.S., 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 at CBPE and Chairman of 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.”

With complementary cultures and a shared commitment to focus, speed, and accountability, the combined organization will operate under the leadership of Barbara Lopez Kunz as CEO, with Fabrice Chartier continuing to lead Simbec-Orion's operations as part of the combined company. With a strategic footprint spanning key global markets, Caidya continues its mission to partner with drug developers to bring life-changing therapies to patients worldwide.

Edgemont acted as exclusive financial advisor to Caidya, and Sidley Austin served as legal counsel to Caidya. Stifel acted as financial advisor and Eversheds Sutherland served as legal counsel to Simbec-Orion and CBPE.

For more information about Caidya and its services, please visit www.caidya.com.

About Caidya
Caidya is a global CRO partner dedicated to helping biopharma innovators navigate the complexities of drug development with greater speed, certainty, and confidence. We specialize in the execution of complex clinical trials, including challenging therapeutic areas, innovative study designs, rare patient populations, and cross-border programs. We partner closely with sponsors to advance breakthrough therapies for patients with unmet medical needs worldwide.

With a strategic footprint across the Americas, Europe, and Asia-Pacific, including deep expertise in China, Caidya combines global reach with local knowledge to support regional and global studies. We work as an extension of our clients to overcome complexity, reduce risk, and generate the high-quality data needed to advance critical therapies.

About Simbec-Orion
Headquartered in the UK, Simbec-Orion is an experienced, technology-enabled, global Contract Research Organisation (CRO) specialising in clinical pharmacology, oncology, and rare diseases. With over five decades of experience, Simbec-Orion provides clinical trial expertise to a wide range of small to mid-sized biotech and pharmaceutical partners around the world.

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