Ryvu Therapeutics has announced the launch of its new CRO business, Keelira.
The business will support Phase I and Phase II programmes, focusing on oncology, haematology-oncology and rare cancers.
It will offer an integrated, sponsor-side approach for biotech and pharma companies — including those based in the US and China — seeking to extend their oncology programmes into Europe.
Based in Poland, Keelira will combine an established operating base in key European markets with the capacity to extend studies across additional EU and non-EU countries as programmes require.
Ryvu stressed that external client programmes would be managed separately from Ryvu's internal drug-development activities under a dedicated quality management system, separate data-management arrangements and client-specific governance.
Dr Kamil Sitarz, General Manager of Keelira, said: "Bringing an oncology programme into Europe requires regulatory strategy, development planning, site selection and clinical execution to move together from the outset."
Keelira gives sponsors one coordinated team across these workstreams: they retain control of the asset, strategy and key decisions, while we take responsibility for execution.
Ryvu said that Keelira would have a “CRO Plus” model, putting Clinical Execution at the core, combined with Strategic Advisory and Central Lab in one team.
Strategic Advisory aligns regulatory requirements, CMC and data readiness planning with execution, ensuring the development strategy translates into an actionable clinical plan.
At launch, Central Lab will offer GCLP-compliant sample management and storage, with plans to expand into integrated pharmacokinetics, pharmacodynamics and biomarker analysis.
