Discuss Your Program

Value by Design

In early clinical development, the quality of execution is as important as the quality of the science. Keelira aligns strategy and execution around the milestones that shape a program's outcome.
Explore the CRO Plus model

A sponsor-minded early development partner

Keelira supports biotechnology and pharmaceutical companies from clinical-entry planning through Phase I and Phase II in Europe, with particular depth in oncology, hemato-oncology and rare cancers. Keelira is Ryvu Therapeutics’ dedicated early clinical development services business, built on the sponsor-side experience of a drug developer advancing its own oncology pipeline.

Our CRO Plus model brings Clinical Execution, Strategic Advisory and Central Lab together in one accountable team. We connect regulatory, CMC, site and operational decisions from planning through delivery, helping sponsors identify dependencies early and turn development strategy into an executable clinical plan.

The Keelira Model

Sponsor control. Accountable execution.

Value by Design combines sponsor control over assets, strategy and key decisions with Keelira’s accountable execution. This approach helps protect timelines, capital efficiency and asset value from avoidable execution risk.

Sponsors work through one integrated model that keeps scientific decisions, operational delivery and clinical data aligned – reducing handovers and clarifying accountability.

Sponsor retains

Trial ownership & accountability

Study design & protocol ownership

Governance & key decisions (incl. go/no-go)

Keelira owns

Day-to-day clinical execution & milestone delivery

Site, investigator & vendor management

Regulatory & safety operations

Data management & inspection readiness

Study execution & close-out

Built by a team with direct sponsor-side experience delivering Ryvu’s own oncology programs.

External client programs are managed separately from Ryvu’s internal drug-development activities under a dedicated quality management system, separate data-management arrangements and client-specific governance. Access to client information is restricted to authorized personnel supporting the relevant program.


This is the Keelira’s CRO Plus model

Strategic Advisory

Defining the right development pathway before execution begins.

Keelira helps sponsors translate scientific potential into a clear, executable clinical development strategy.

  • Clinical development planning
  • CMC strategy
  • European regulatory and submission strategy
  • Clinical pharmacology strategy
  • Protocol and study design
  • Value-inflection mapping
  • KOL and advisory board engagement

Clinical Execution

Providing coordinated, accountable delivery across countries, sites and vendors.

Keelira manages Phase I and Phase II programs from study start-up through enrollment and data delivery, coordinating execution against agreed development milestones.

  • Clinical-entry and European regulatory submission support
  • Country and site selection
  • Study start-up and activation
  • Investigator and site engagement
  • Enrollment and performance management
  • Vendor, timeline and data coordination

Central Lab

Protecting sample integrity and supporting development decisions.

Current Central Lab capabilities include GCLP-compliant sample management and storage. Keelira plans to expand the offering into integrated PK, PD and biomarker analysis, building on its existing infrastructure.

  • Sample strategy
  • Biomarker strategy - advisory support
  • GCLP-compliant sample management and storage
  • Integrated PK analysis - planned
  • Integrated PD analysis - planned
  • Integrated biomarker analysis - planned

GLOBAL
PROGRAM
EXPANSION

For sponsors entering Europe – especially US- and China-based companies – Keelira builds on existing evidence and development work, identifies Europe-specific alignment or bridging needs, and coordinates regulatory planning, sites, vendors and clinical delivery. The objective is to generate evidence designed to support European regulatory expectations and broader global development.

How we engage

Keelira supports sponsors from clinical-entry planning through Phase I and Phase II, with the scope adapted to the stage and requirements of each program. Sponsors can engage Keelira at any of four stages while benefiting from consistent scientific coordination, execution discipline and accountability.

Clinical-entry planning
Translating the development package into a clear, executable European clinical plan.

Phase I planning and start-up
Preparing and initiating the first clinical study.

Phase I delivery and Phase II transition
Managing recruitment risk and site performance while preparing decision-ready data for the transition to Phase II.

Phase II delivery
Coordinating multi-country execution and proof-of-concept data generation.

Execution timelines are business-critical
Early engagement allows upstream decisions to be made with downstream execution in mind-reducing avoidable delays and helping protect the financing, partnering and portfolio milestones that depend on timely clinical data.

Leadership perspectives

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In early clinical development, the most consequential decisions are often made before the first patient is enrolled. The development plan, regulatory pathway, CMC assumptions, clinical pharmacology and protocol design all determine what will later be operationally possible. Keelira was built to keep those decisions connected with execution. We look at the program from the sponsor's perspective – what evidence is needed, when it is needed, and what it means for the asset's financing and partnering options.

Kamil Sitarz, PhD, MBA
General Manager

"

Delivery in early clinical development is about more than the number of sites activated — it depends on the right investigators, a realistic view of patient access, and site engagement that continues well after activation.Our role is to identify those risks early and coordinate the response before they affect enrollment or the next data milestone.

Tomasz Szeląg
Head of Clinical Operations

"

From the sponsor’s perspective, vendor management is ultimately about protecting the program – its timelines, budget and ability to respond when priorities change. Poorly defined scopes, fragmented responsibilities and contracts that do not reflect the realities of delivery, can quickly become development risks. We build the vendor and contracting framework around the sponsor’s objectives, ensuring that responsibilities are clear, incentives are aligned and issues can be escalated and resolved without unnecessary delay. The sponsor retains visibility and control, while Keelira coordinates the partners required to deliver the program

Marine Andriveau
Head of Contracts & Vendors

"

Translational science should be designed around the clinical decisions the program will need to make - defining the biomarker and sample strategy, sampling schedule, analytical methods and data flows before the study begins. Our objective is to design the biomarker and sample strategy around the decision-relevant questions the program will need to address.

Aleksandra Sabiniarz, PhD

Head of Lab Services

Europe, under one execution model

Keelira gives sponsors a single point of accountability for early clinical development across Europe. 

From its base in Poland, Keelira combines central scientific and operational leadership with established investigator relationships in Poland, Spain, France and Italy. It has the capacity to extend studies across additional EU and non-EU countries as programs require.


70+ sites in Poland

20+ sites in Spain

15 + sites in France

15 + sites in Italy

Additional EU and non-EU markets / Extended according to program requirements.

Local delivery is coordinated through a single Keelira governance structure, maintaining clear accountability across countries, sites and partners.

Resources

Access selected materials on Keelira’s model, capabilities and European clinical development platform. 

Turn your European development strategy into an executable clinical program

Whether you are preparing for clinical entry, expanding an existing program into Europe – including programs originating in the US and China – or addressing a specific execution challenge, tell us where your program stands and what decision or milestone comes next.

Every inquiry is reviewed by a senior member of the Keelira team to understand the program and define the appropriate next step.

CONTACT:

Keelira

contact@keelira.com

Leona Henryka Sternbacha 2
30-394 Kraków, Poland

 

Keelira is a dedicated brand of Ryvu Therapeutics