About Us

About
About

Leading the way to a healthier future with a forward-thinking CRO

We believe that what is most valuable in clinical research arises from the combination of knowledge, experience, the use of technology and the involvement of people who want to create a healthier future.

We help our partners: pharmaceutical and biotechnology companies, medical devices manufacturers, scientific and research institutions, and start-ups by working together on the development of new molecules and innovative devices or technologies.

Axcellant — Global CRO

We Build Trust In All Our Interaction

Wojciech Kula
Founder & CEO
Almost 20 years of experience in clinical research has led me to the Axcellant foundation – a unique Contract Research Organization (CRO) that delivers faster clinical research to a higher standard. Thanks to this approach, our team contributes robust clinical evidence generation to products that can improve patients' quality and extent of life.

Axcellant follows in the footsteps of ClinMed Pharma, a CRO that has offered services to pharmaceutical and biotech companies since 2006.

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Axcellant’s team has experience in the nuances of the clinical development of small molecules, biological agents, and advanced therapeutics. We have supported and continue supporting pharmaceutical companies, medical devices manufacturers, non-commercial organisations, and institutions.

By conducting many complex and highly demanding projects, we have confirmed our competence, which we are now deepening in areas such as cardiology and nuclear medicine among others.

See any topics worth exploring together? Let’s meet for a quick call!.

Our Values

Axcellant - Knowledge

Knowledge

We combine knowledge and experience of medical, biostatistics, regulatory and clinical operations experts, to effectively conduct your research processes.

Axcellant - Technology

Technology

We implement the latest technologies, to improve, speed up and automate processes, thanks to which we are sure that the data we provide are reliable and credible, and the patients are safe.

Axcellant - Patient

Patient

We are all human. We can all become patients. We are aware of this, that's why everything we do, we do it with the greatest care, reliability and precision.

At Axcellant, we have 10 core values that reflect our culture:

1. Partnerships

We work in partnership internally and externally building trust in every interaction.

2. Patients first

In our interactions we bring the patient perspective to the fore.

3. Quality

We have a quality by design approach to our systems, processes and training.

4. Communication

We listen actively to each other and our customers to understand.

5. Self-Development

We take individual accountability in our continuous learning to build competency ahead of opportunity.

6. Delivery

We deliver on our commitments to each other and our customers.

7. Diversity

We take individual accountability to build a large diversity in our network.

8. Science

We are driven by science and the positive impact it has on society.

9. Courage

We seek excitement in big challenges and think critically before we act.

10. Doing the right Thing

We default to doing the right thing, with honesty, integrity and transparency.

Services

Nuclear Medicine & Imaging Expertise

Leveraging extensive knowledge in nuclear medicine and diverse imaging modalities, including Imaging Core Lab support, we deliver high-quality data and expert guidance to enhance the success of your study.

Integrated Medical Device Services

Our team secures medical device development with pre- and post-market planning, ensuring compliance with FDA CFR, ISO, and MDR standards.

Clinical Development

We support clients from early-phase strategy to regulatory approval every step of the way. Design and manage clinical trials that generate high-quality, regulatory-compliant data across all development phases.

Clinical Operations

Axcellant’s team guarantees streamlined, end-to-end clinical trial execution. Our experienced team ensures the delivery of timely, compliant, and cost-effective studies tailored to meet your goals.

Biostatistics & Data Management

With expertise in statistical modelling, programming, and data collection methodology, we deliver accurate and reliable insights to support your research and decision-making.

Regulatory Strategy & Compliance

Our regulatory team specializes in crafting effective regulatory strategies and ensuring compliance throughout the project lifecycle. From initial planning to completion, we provide expert guidance to navigate complex regulatory frameworks with precision and efficiency.

Pharmacovigilance & Product Safety

We ensure timely detection, assessment, and reporting of adverse events in full compliance with FDA, EMA, and global pharmacovigilance regulations. Our services prioritize patient protection and uphold the highest product safety standards throughout the lifecycle.

Clinical Quality

Our robust systems, streamlined processes, and comprehensive training programs have demonstrated excellence through numerous successful audits and inspections, ensuring the highest compliance and quality standards.

Temporary Clinical Resourcing Solutions

Our resourcing division collaborates closely with you to identify and fulfil your specific needs, providing flexible and tailored solutions to support your operations.

Resources

Insights from Turku PET Symposium 2025 - Axcellant

Insights from Turku PET Symposium 2025

Axcellant participated in the PET Symposium 2025, held in Turku, marking 50 years of PET radiochemistry at the Turku PET…

EU regulatory reforms aim to unlock medtech innovation - Axcellant

EU regulatory reforms aim to unlock medtech innovation

The EU is moving forward with key upgrades to its medical device and diagnostics regulations, specifically under the Medical Device…

Gene therapy expands beyond oncology — and brings new challenges - Axcellant

Gene therapy expands beyond oncology — and brings new challenges

Gene therapies now account for most ATMP clinical trials, with a balanced distribution between in vivo and ex vivo approaches.…

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