Discuss Your Program

Value by Design

In early clinical development, the quality of execution is as important as the quality of the science itself. Keelira works around the value inflection points that shape a program’s outcome – protecting time, capital and asset value.
Keelira helps biotechnology companies add Europe to early oncology programs – including programs that started in Asia or the US, often at the Phase Ib/II expansion step – connecting regulatory strategy, clinical delivery and sample operations within one accountable team.
Explore Our Model

A sponsor-minded early development partner

Keelira is an early clinical development partner for biotechnology and pharmaceutical companies running Phase I and Phase II oncology trials in Europe. Built inside Ryvu Therapeutics, a Warsaw-listed clinical-stage oncology company in Kraków, we approach clinical development from the perspective of a drug developer, not a vendor. 

Our team planned and ran Phase I/II oncology trials, including first-in-human, as the sponsor for Ryvu and on the sponsor’s side for partners. We bring that experience – about 50 permanent staff, about 30 of them in clinical operations, plus medical, regulatory, CMC, quality, contracts and Central Lab – together in one accountable team, for programs where scientific judgment, execution discipline and speed to data matter most.

Client programs are kept apart from Ryvu’s own pipeline. Access is need-to-know, and before you share confidential materials, we complete a conflict assessment and give you the outcome in writing. 

The Keelira Model

Keelira runs Europe for you, or works alongside your CRO.

Keelira combines clinical execution, strategic advisory and Central Lab within one accountable team. We run the European part of your study in place of a CRO for Europe, with our own team and qualified vendors – or oversee your CRO in Europe as your sponsor-side team, adding workstreams where assigned. 

Instead of coordinating separate consultants, laboratories and vendors, sponsors work through one integrated model that keeps scientific decisions, operational delivery and clinical data aligned. This means fewer handovers and clearer accountability: each task has one owner. In both models, you contract directly with Ryvu Therapeutics S.A., Keelira’s contracting entity. 

Sponsor retains

 

    • Trial ownership & accountability
    • Study design & protocol ownership
    • Governance & key decisions (incl. go/no-go)

Keelira’s agreed European scope

  • Day-to-day clinical execution & milestone delivery, as assigned
  • Site, investigator & vendor management
  • Regulatory & safety operations
  • IMP import oversight, data & sample flows
  • Study execution & close-out

    • Built by a team that has been on the sponsor side ourselves – inside Ryvu Therapeutics. 

    You keep the decisions.

    Keelira works on your side in Europe. 


    A named European lead is your single contact in both models

    Clinical Execution

    Taking ownership of delivery across countries, sites and vendors.

    Keelira manages the European part of Phase I and Phase II studies, from start-up through enrollment, data delivery and key development milestones.

    • CTA support via CTIS
    • Country and site selection
    • Study start-up and activation
    • Investigator and site engagement
    • Enrollment and performance management
    • Vendor, timeline and data coordination

    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
    • Regulatory and submission strategy
    • Clinical pharmacology
    • Protocol and study design
    • Value-inflection mapping
    • Country and patient logic for your indication

    Central Lab

    Protecting the sample chain behind development decisions.

    Keelira plans sample operations with the clinical team – from lab kits and collection windows to shipment routes and storage.

    • Lab kits
    • Sample management
    • Sample storage
    • Integrated PK/PD and biomarker analysis (planned)

    GLOBAL
    PROGRAM
    EXPANSION

    For biotechnology companies, licensees and NewCos with early clinical evidence generated in Asia or the US, Keelira assesses how the existing development package can be carried forward – identifying any alignment or bridging required and shaping the next stage to generate European data that regulators, partners and licensees can use. Our focus is clinical entry through Phase II; in global Phase III programs, Keelira takes on only defined European countries or workstreams.

    How we engage

    Keelira supports sponsors from clinical entry planning through Phase II, with the scope of engagement adapted to the stage and requirements of each program. 

    Clients can engage Keelira at any of four stages. Every engagement starts with a scoping call, then a no-cost program review and proposal in about 10 working days, after a CDA and a conflict assessment; you commit only when the service agreement is signed. 

    Preclinical to CTA
    Translating the preclinical package into an executable clinical development plan.

    CTA to Phase I
    Preparing and initiating the first clinical study. 

    Phase I to Phase II 
    Managing recruitment risk and site performance through dose escalation and the Phase Ib/II expansion step – often where Europe is added – and preparing milestone-ready data for Phase II. 

    Phase II 
    Delivering multi-country execution and a robust proof-of-concept dataset. 

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

    For programs that started outside Europe, early assessment also reduces the risk of discovering late in the program that elements of the existing package cannot be transferred, documented or adapted retrospectively for European development. 

    Leadership perspectives

    "

    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

    "

    Sample operations should be designed around the clinical decisions the program will need to make. That means defining the sampling schedule, lab kits, shipment routes and data flows before the study begins – not adding them once samples are already being collected. The integrity of the sample chain and the alignment of sample data with clinical data are critical to interpreting emerging results. Our objective is to ensure that every sample contributes to an answer that can move the program forward. 

    Aleksandra Sabiniarz, PhD

    Head of Central Lab

    Europe, under one execution model

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

    From its base in Kraków, Poland, Keelira combines central scientific and operational leadership with established site relationships in Poland, Spain, France and Italy, and qualified local partners elsewhere in Europe. Team members have run trials in 29 European countries. This allows sponsors to access local regulatory, clinical and site expertise without managing a fragmented network of country-level providers.


    70+ sites in Poland

    20+ sites in Spain

    15 + sites in France

    15 + sites in Italy

    + UK, Germany & broader CEE 

    European reach through one coordinated team and qualified partners 

    Local delivery is coordinated through a single Keelira governance structure, maintaining clear accountability across countries, sites and partners – including an EU legal representative for sponsors based outside the EU, where agreed. 

    Resources

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

    Discuss your program with our team

    Whether you are preparing to enter the clinic, expanding an existing program into Europe or addressing a specific execution challenge, share the context with us. 

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

    CONTACT

    kamil.sitarz@keelira.com

    We Chat:

    Keelira

    contact@keelira.com

    Leona Henryka Sternbacha 2
    30-394 Kraków, Poland

     

    Join Keelira

    At Keelira, we bring a drug developer’s perspective to early clinical development.
    Our team connects clinical execution, strategic advice and sample operations
    to help move Phase I and II oncology programs forward in Europe.

    Join us in shaping how early development is planned and delivered.