- Keelira offers an integrated, sponsor-side approach for biotech and pharma companies, including those based in the US and China, seeking to extend oncology programmes into Europe, backed by multi-country experience and established relationships with oncology sites in key European markets.
- Its “CRO Plus” model brings Clinical Execution, Strategic Advisory and Central Lab together in one team, giving sponsors a single point of accountability supported by direct Phase I and Phase II oncology experience.
- External client programmes are managed separately from Ryvu’s internal drug-development activities under a dedicated quality management system, separate data-management arrangements and client-specific governance.
Ryvu Therapeutics today launched Keelira, its dedicated early clinical development services business for biotech and pharma companies seeking to extend their oncology programmes into Europe.
Keelira’s operating model was developed within Ryvu to advance its oncology pipeline and later applied in external clinical collaborations, including operational responsibility for Phase II studies and multi-country site activation and patient enrollment across hematologic malignancies and solid tumors.
Keelira supports biotech and pharma companies from clinical-entry preparation through Phase I and Phase II development, with particular depth in oncology, hemato-oncology and rare cancers. Companies can engage Keelira ahead of European clinical entry, when early alignment matters most. Based in Poland, Keelira combines an established operating base in key European markets with the capacity to extend studies across additional EU and non-EU countries as programs require.
The team behind Keelira has experience supporting Phase I and Phase II programs in hemato-oncology and solid tumors, including multi-country patient recruitment in rare oncology indications.
Kamil Sitarz, PhD, General Manager of Keelira, said: “Bringing an oncology program 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.”
A drug developer’s approach to clinical services
Keelira’s “CRO Plus” model puts Clinical Execution at the core, combined with Strategic Advisory and Central Lab in one team. Strategic Advisory connects regulatory, CMC and data-readiness planning directly with execution, so development strategy translates into an executable clinical plan.
At launch, Central Lab includes GCLP-compliant sample management and storage, with planned expansion into integrated PK, PD and biomarker analysis.
Keelira builds on investigator relationships established through Ryvu’s work with more than 70 oncology sites in Poland, more than 20 in Spain and more than 15 in each of France and Italy.
Further information about Keelira is available at keelira.com.
