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.
A strategic leader with over 25 years of experience in clinical development, Michał has supported more than 300 trials for pharma, biotech, and CROs worldwide—spanning oncology, rare diseases, and advanced modalities, including radiopharmaceutical programs and SaMD. As Chief Strategy Officer, he leads Axcellant’s commercial and partnership strategy, bringing CRO-and-CDMO perspective to feasibility, site readiness, imaging/dosimetry operations, and regulatory alignment. His mandate is clear: keep Axcellant’s boutique CRO model sharp, flexible, and built for small and mid-sized sponsors—delivering senior involvement, operational reliability, and speed.
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.
Our 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.
An experienced manager of complex, multi-country studies, Yana has delivered 30+ Phase I–IV trials across APAC, the US, and Europe—covering IMPs, medical devices, and ATMPs. A specialist in global regulatory oversight (FDA, EMA, PMDA), she drives end-to-end operations—from protocol design and CTIS submissions to risk mitigation—ensuring top-tier compliance (ICH GCP, ISO 14155) and moving every project toward successful approval.
Quality Assurance Specialist with over 20 years of experience in the pharmaceutical and clinical trials industry, specializing in Good Clinical Practice (GCP). Extensive expertise in Clinical Site Audits, Vendor Qualification Audits, Internal System Audits, Mock Inspections, and SOP development. Skilled in Risk Assessment, Process Mapping, and CAPA Management, with a proven track record of conducting 300+ audits worldwide across Investigational Sites, Biotech, and CRO organizations. As a Quality Manager and Auditor, successfully established Quality Management Systems (QMS) in small and mid-sized companies. Possesses in-depth knowledge of ICH guidelines, GCP principles, and key FDA guidance for industry.
PR lead and Managing Partner at Presso, Axcellant’s communications partner for strategy, media relations, and analytics-driven outreach. Previously spent 6+ years in journalism, including as editor and reporter at Poland’s largest news TV channel. At Axcellant, he directs communications and media relations, shapes thought leadership and press materials, and prepares spokespeople—ensuring consistent visibility and disciplined execution across international markets.
Our footprint is global. We plan, start, and run studies across Europe and the US, with selected APAC coverage through strategic partners, including Japan. The map highlights active and completed trial locations—sites, investigators, and regions where our senior teams operate with local fluency and regulatory alignment (FDA, EMA, PMDA). Boutique by design yet scaled for reach, we deliver consistent oversight, faster start-up, and reliable execution—wherever your study needs to go.
We combine knowledge and experience of medical, biostatistics, regulatory and clinical operations experts, to effectively conduct your research processes.
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.
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.
We work in partnership internally and externally building trust in every interaction.
In our interactions we bring the patient perspective to the fore.
We have a quality by design approach to our systems, processes and training.
We listen actively to each other and our customers to understand.
We take individual accountability in our continuous learning to build competency ahead of opportunity.
We deliver on our commitments to each other and our customers.
We take individual accountability to build a large diversity in our network.
We are driven by science and the positive impact it has on society.
We seek excitement in big challenges and think critically before we act.
We default to doing the right thing, with honesty, integrity and transparency.
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.
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