Witold Żmuda MD, PhD
Clinical Research & Site Operations Expert
Witold Żmuda is a physician specialising in internal medicine and cardiology, with over 30 years of experience in medical practice. He has held leadership positions in healthcare organisations, including in interventional cardiology and internal medicine. As a principal investigator and sub-investigator, he has participated in numerous clinical studies of medicinal products and medical devices across cardiovascular, metabolic, respiratory and gastrointestinal conditions.
He is a co-owner of Medicome, a clinical research site, and a primary care practice. He brings together the perspectives of a physician, investigator and healthcare business owner to support sponsors, CROs and research sites in assessing study feasibility, organising study delivery and providing care for participants.
His connection with Medicome also creates opportunities to combine G&G Medvision’s consulting expertise with the conduct of selected studies at the associated site, subject to project requirements, available resources and sponsor selection.
Witold Żmuda MD, PhD
Clinical Research & Site Operations Expert
Iwona Kobielusz-Gembala is a physician specialising in internal medicine and cardiology, with extensive experience in clinical practice. She has been involved in clinical research since 2002, beginning at the Department of Cardiology in Katowice-Ochojec. She previously served as Deputy Head of the Department of Internal Medicine and Clinical Pharmacology, where she also developed her knowledge and experience in clinical pharmacology.
As a principal investigator and sub-investigator, she has participated in numerous studies of medicinal products and medical devices across a range of therapeutic areas. She combines a physician’s perspective on patient care with practical expertise in study delivery and research site operations. At G&G Medvision, she contributes to audits and assessments of healthcare organisations, with a particular focus on clinical research sites.
She is a co-owner of Medicome, a clinical research site, and a primary care practice. Her clinical and organisational experience supports sponsors, CROs and research sites in assessing study feasibility, preparing teams and improving study processes, with particular attention to participant safety and the realities of clinical practice.
Iwona Kobielusz-Gembala MD, PhD
Clinical Research & Site Assessment Expert
Magdalena Szlezinger is a qualified legal counsel with experience advising businesses and clinical research organisations in Poland, Germany and Switzerland. A graduate of the Faculty of Law and Administration at the University of Silesia, she qualified as a legal counsel in 2008 and is also a certified mediator. She combines expertise in civil and commercial law with practical experience supporting clinical research projects.
She advises sponsors and CROs on drafting, reviewing and negotiating domestic and international agreements, including contracts with research sites, investigators and service providers. Her work covers contractual responsibilities, confidentiality, rights to study results and the resolution of issues arising throughout a project.
She also provides legal advice on the preparation and conduct of studies involving medicinal products and medical devices, taking account of the EU Clinical Trials Regulation, the Medical Device Regulation and applicable national legislation. Through the collaborating law firm, her services also include EU legal representation for non-EU sponsors, subject to formal appointment and agreed terms.
Magdalena Szlezinger
Legal Counsel — Clinical Research & International Contracts
Marcin Szlezinger has over 20 years of experience in clinical research involving medicinal products and medical devices. He combines perspectives gained from working with sponsors, CROs and research site management. His experience spans national and international projects, including early- and later-phase trials, non-commercial studies, and projects involving medical devices and diagnostics.
He specialises in clinical research strategy, study design, protocol development and study documentation, as well as budget planning, timelines and project oversight. He advises sponsors, biotech companies and research sites on translating development objectives into feasible study plans and preparing the processes, teams and resources needed for delivery.
His work includes CRO and vendor selection, sponsor oversight, risk management and resolving operational challenges in ongoing studies. He also conducts audits and training, helping organisations strengthen their research capabilities, improve quality and prepare for audits and inspections.
Marcin Szlezinger
Clinical Research Strategy & Operations Expert
Dominika Grygier is a biomedical engineer and university professor at Wrocław University of Science and Technology, with over 20 years of research experience and practical involvement in the MedTech industry. She specialises in medical device design and safety assessment, materials engineering and biomechanics.
As a co-founder, former long-serving CEO and current board member of Orthoget, she combines engineering expertise with the perspectives of a medical device manufacturer and clinical investigation sponsor. She supports product development from concept assessment and material selection through preclinical testing strategy and interpretation of results to assessing readiness for clinical investigation.
She also advises on the implementation of quality management systems aligned with ISO 13485. Her work includes technical consulting, expert assessments and audits of processes and documentation, helping companies identify development gaps, address technical risks and prepare for the next stage of their projects.
Dominika Grygier PhD, DSc
Medical Device Development & Preclinical Research Expert