With nearly 20 years of experience in clinical research, Marcin brings deep knowledge of international clinical operations and strategic management. His career progression from Clinical Research Associate to Director of Operations at multinational CROs and pharmaceutical companies has given him extensive insight into clinical trial delivery in Europe, North America, and Asia-Pacific.

Throughout his career, Marcin has managed clinical trials across nearly 20 therapeutic areas, maintaining full adherence to ICH GCP standards, FDA regulations, and EMA guidelines for both medicinal products and medical devices. His capabilities include clinical trial design, having authored and reviewed numerous clinical protocols, delivering scientific rigor and operational feasibility while meeting diverse regulatory requirements in various regulatory environments. In his director-level roles, he has overseen international multi-site clinical programs, successfully navigating the complexities of varied regulatory landscapes.

As a recognized GCP expert with thorough understanding of both FDA and EMA regulatory frameworks, Marcin has designed and delivered advanced training programs on international clinical trial management and compliance standards for clinical research professionals worldwide. His proficiency has been validated through numerous successful regulatory inspections by both FDA and EMA, as well as national health authorities, all with positive outcomes.

His practical experience from protocol development through study close-out in multiple regulatory jurisdictions, combined with his strategic business perspective, positions him to deliver end-to-end clinical research solutions for both regional and international studies. His leadership maintains the highest standards of quality and compliance while adapting to the evolving needs of sponsors worldwide.

Marcin holds an MBA and completed Medical Analytics studies at the Medical University of Gdańsk. This combination of business acumen and scientific analytical training enables him to bridge strategic planning with practical trial execution throughout different regulatory environments, balancing both commercial viability and regulatory requirements internationally.

Seasoned Clinical Project Manager with 17+ years of experience in clinical research, combining insights from both CRO and sponsor perspectives. Starting her career as a CRA and advancing to global roles in trial and project management, Anna has gained hands-on expertise in all stages of the clinical development process.

She has led Phase I-IV trials and medical device investigations in accordance with ICH GCP, ISO 14155, and MDR standards. Her therapeutic portfolio spans oncology, cardiology, neurology, as well as pulmonology, nephrology, and endocrinology. Anna has successfully managed complex, global clinical programs, ensuring adherence to EMA, FDA, and international regulatory requirements.

Known for her operational excellence and quality focus, Anna provides end-to-end leadership across all study phases. Her work in global CROs and a leading pharmaceutical company has equipped her with in-depth knowledge of integrated team management, including Regulatory Affairs, Legal, Contracts, Data Management, and Quality Assurance.

Anna specializes in implementing quality management systems for research institutions, developing comprehensive SOPs and ensuring GCP compliance across academic and commercial settings. Her expertise in bridging academic research with industry standards enables seamless collaboration between university hospitals and pharmaceutical sponsors, particularly in early-phase and innovative therapy trials.

With a comprehensive understanding of clinical operations and a proactive, solution-oriented mindset, she is skilled in vendor oversight and risk mitigation. Anna’s scientific background – a PhD in Chemistry from the University of Warsaw – strengthens her analytical approach and commitment to delivering high-quality, compliant clinical trials.

With over 15 years of experience at the interface of clinical practice and research, Paweł combines a strong background in rheumatology, medical imaging, and quantitative analysis. His work focuses on translating clinical questions into well-designed studies and complex data into scientifically robust and clinically meaningful conclusions.

Paweł is an Assistant Professor at Collegium Medicum, Nicolaus Copernicus University, and a Senior Assistant at University Hospital No. 2 in Bydgoszcz, where he has headed the DXA Center since 2015. He has contributed to clinical trials and observational studies conducted with pharmaceutical and academic partners, with particular expertise in osteoporosis, fracture risk assessment, inflammatory rheumatic diseases, biologic therapies, and bone-active treatments.

As a biostatistician, Paweł supports studies from design through analysis and reporting, including sample size estimation, randomization, statistical analysis planning, regression modelling, analysis of variance, and diagnostic accuracy assessment. His work follows internationally recognized methodological and reporting standards, including ICH E9/E9(R1), CONSORT, STROBE, and PRISMA.

As a medical writer, Paweł works across a broad range of therapeutic areas and study types, extending well beyond his own clinical specialty. He has authored and reviewed clinical study protocols, statistical analysis plans, clinical study reports, and scientific manuscripts for clinical trials, observational studies, and real-world research. He is also an author or co-author of numerous peer-reviewed publications and a reviewer for international scientific journals.

Paweł holds an MSc in Experimental Physics and a PhD in Health Sciences. His multidisciplinary background enables him to combine clinical insight, scientific writing, and quantitative expertise to deliver clear, rigorous, and decision-relevant research documentation.