About the program
About the program
Why Choose This Program?
Clinical trials are the backbone of evidence-based medicine and innovation in healthcare. With rapid developments in science, regulation, and technology, there is growing demand for professionals who can navigate the complexities of conducting and monitoring trials across diverse settings. Conducting and Monitoring Clinical Trials is a postgraduate program designed to equip future clinical research professionals with the practical skills, regulatory insight, and ethical mindset required to work at the highest standards of international research.
Whether you are entering the field or deepening your expertise, this program provides hands-on, up-to-date training grounded in real-world practice.
This international edition is built on the strong foundation of over 15 years of experience and 40 successful Polish editions of our clinical trials education program. Throughout these years, we’ve trained thousands of professionals now working in top research centers, CROs, pharmaceutical companies, and regulatory bodies across Europe.
Our faculty includes world-class experts—international lecturers, investigators, medical advisors, GCP auditors, and regulatory professionals—who bring not only academic insight but also practical knowledge from the front lines of clinical research. Their experience ensures the program reflects the current challenges and expectations of the global clinical trials landscape.
As part of the study program, internship opportunities are available at Novo Nordisk.
Postgraduate Studies Open Days
About KU
Key Highlights
Entirely in English – ideal for international participants
Online weekend sessions (Saturday–Sunday), optimized for working professionals
2 semesters, 201 academic hours
30 ECTS
100% experts in the field, 30% international lecturers
Over 50% of the program involves interactive workshops, simulations, and project work
Realistic group project with presentation and peer feedback
Program partner
Who Should Apply?
This program is designed for individuals who want to work in the clinical trials sector, especially: - Life sciences graduates entering clinical research. - Nurses, pharmacists, and allied health professionals transitioning to clinical trials operations. - Junior physicians who want to enter the clinical trials field. - Junior employees of CROs, pharma, biotech or medtech companies. - PhDs or postdocs seeking roles as study coordinators or investigators. - Regulatory and QA specialists entering clinical research contexts. Minimum entry requirements: completed higher education (Bachelor’s or higher) and English proficiency (minimum B2). Requirements will be checked based on CV and certificates.
Learning Outcomes
By completing the program, participants will be able to:
- Explain the structure and phases of clinical trials, including key methodologies used in early and late-phase studies.
- Apply international regulatory and ethical standards, including ICH-GCP R3, EU CTR, GDPR, GMP, GLP, and local ethics procedures.
- Manage clinical trial documentation: protocols, investigator brochures, informed consent forms, and trial master files.
- Conduct and support monitoring visits (PSSV, SIV, IMV, COV) and prepare monitoring reports.
- Work effectively in multinational trial teams, understanding cultural, legal, and logistical nuances.
- Utilize modern tools and platforms such as EDC, CTMS, and eTMF, and understand the evolving role of AI in data management and remote monitoring.
- Assess and manage risks in trial conduct, including deviations, non-compliance, and fraud prevention.
- Interpret pharmacovigilance requirements, including adverse event reporting, safety updates, and pharmacological documentation.
- Implement quality assurance mechanisms: internal audits, inspection readiness, and CAPAs.
- Communicate clearly and persuasively with investigators, sponsors, and ethics committees.
- Critically evaluate real-world trial scenarios, propose operational solutions, and defend recommendations in a professional setting.
Program
Program Structure (Selected Modules)
1. Clinical trials foundations
- Fundamentals of Clinical Trials: Structure, Terminology and Drug Development Processes, clinical pharmacology, 1st phase and bioequivalence Trials, Pediatric Clinical Trials
2. International Regulatory and Ethical Frameworks
- GCP, GMP, GLP, GDPR, EU CTR, ethics committee procedures, principles of Ethics in Clinical Trials, International & European Regulatory Landscape in Clinical Trials (ICH, EU CTR, FDA, CTIS), Decentralized Clinical Trials (DCT) and Remote Monitoring
3. Clinical Project & Site Management
- Feasibility, budgeting, contracting, communication skills
4. Patient-Centered Research & Pharmacovigilance
- Recruitment, retention, clinical pharmacology, adverse event reporting
5. Clinical Quality, Documentation and Compliance
- Documentation standards, audits and inspections, risk of fraud
6. Data Management and AI in Clinical Trials:
- Management Systems and data analysis in Clinical Trials, Innovative Approach to data management in Clinical Trials – Data Managemet and AI, IT for Conducting and Monitoring Clinical Trials, AI in Clinical Trials
7. Clinical Trial Operations Management – Foundations
- CRA Role, risk-Based Monitoring Strategies and RBQM, visits in clinical trials - planning and conducting, Clinical Trial Operations Management – Practice, Workshops on Clinical Trial Operations Management
8. Clinical Trial Operations Management – Practice
- workshops on Clinical Trial Operations Management
9. Final Project
- Collaborative project with real-case analysis and defense, teams of 3–5 develop a comprehensive clinical trial operational analysis or study protocol proposal, presented and defended before a panel of industry practitioners
The programme consists of 201 teaching hours.
Sessions
Planned sessions in the first semester:
- 07-08.11.2026
- 28-29.11.2026
- 12-13.12.2026
- 09-10.01.2027
- 30-31.01.2027
- 27-28.02.2027
Community
Leading lecturers
Łukasz Wiech jest lekarzem, specjalistą zdrowia publicznego z ponad 15-letnim doświadczeniem w badaniach klinicznych oraz szeroką ekspertyzą w zarządzaniu ochroną zdrowia. Absolwent MBA dla Kadry Medycznej w Akademii Leona Koźmińskiego.
Obecnie pełni funkcję Dyrektora Medycznego w sieci ośrodków Trialmed w Polsce, gdzie odpowiada za rozwój zespołu lekarskiego, jakość prowadzonych badań i bezpieczeństwo pacjentów. Jako lider studiów w obszarze zdrowia na Akademii Leona Koźmińskiego wykształcił ponad 2000 absolwentów, rozwijając ich kompetencje w zakresie zarządzania w ochronie zdrowia i badaniach klinicznych. Będąc także założycielem i promotorem środowiska WE! Are Clinical Research realizuje misję tworzenia platformy rozwoju dla specjalistów badań klinicznych w Polsce i Europie.
Jest certyfikowanym trenerem zaawansowanej gry symulacyjnej SysTeamsChange®. Wspiera menedżerów i organizacje w rozwijaniu praktycznych umiejętności wprowadzania i zarządzania zmianą, szczególnie w sektorze zdrowia. Prowadzi także prace badawcze, koncentrując się na wykorzystaniu gier symulacyjnych jako narzędzia edukacyjnego w procesach zarządzania, łącząc teorię z praktyką i wyznaczając nowe kierunki rozwoju w tej dziedzinie.
Łukasz Więch wierzy, że przyszłość ochrony zdrowia opiera się na edukacji, innowacji i współpracy, dlatego działa na styku nauki, biznesu i praktyki klinicznej, tworząc wartość dla pacjentów, profesjonalistów i organizacji.
Absolwent Oxford Brooks University (MBA Business Administration), Wyższej Szkoły Zarządzania (zarządzanie biznesem) oraz Szkoły Głównej Gospodarstwa Wiejskiego (Wydziału Technologii Żywności). Od 18 lat związany z badaniami klinicznymi. Dzięki wieloletniej pracy w największych korporacjach farmaceutycznych oraz globalnych firmach CRO, na stanowiskach specjalistycznych, kierowniczych oraz dyrektorskich doskonale rozumie rynek badań klinicznych. Zna perspektywę sponsora oraz firm prowadzących badania na jego zlecenie.
Od 2015 roku związany zawodowo z firmą PPD, gdzie we współpracy z wielodyscyplinarnymi zespołami badaniowymi zarządza globalnymi projektami badawczymi. Jako Project Director oraz Oversight Director odpowiada za zarządzanie globalnymi programami i projektami oraz budowanie relacji ze strategicznymi klientami organizacji.
Wieloletni wykładowca oraz promotor Akademii Leona Koźmińskiego, Katolickiego Uniwersytetu Lubelskiego oraz Akademii Medycznej w Lublinie. Autor oraz kierownik merytoryczny programu studiów podyplomowych – zarządzanie projektami w badaniach klinicznych.
Admission procedure
- Admission to the 1st edition of the programme is based on the order of applications until 15th October 2026. Classes will commence on 7th, November 2026.
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We invite you to apply – only a few places left!
The thematic modules of the program are completed through assessments in the form of individual projects (essays) or group projects (case study analyses). The studies conclude with a group presentation, which serves as the final stage of preparing and delivering the team’s capstone project.
- a copy of a Bachelor or Master diploma; in case of the diplomas issued outside Poland the candidates are kindly asked to provide also a copy of the diploma supplement (transcript of records) and an official translation of both the diploma and the supplement into Polish
- a certificate of English level B2/C1
- a photograph in electronic JPEG format
- payment slip for the amount of the admission fee
- National ID or passport
Additional information for international students:
Participants of postgraduate studies have the status of study participants, not student status. Therefore, we would like to emphasize that our University cannot assist in obtaining a student visa for participants of postgraduate studies. Please consider this when making decisions regarding your application to our studies. We also inform you that our university does not have its own dormitory and does not assist in accessing other dormitories.
Please, check the description and application rules of the course you're interested in.
Fill in our application form online.
The fee should be transferred to the University account or could be settled while submitting the application form.
Tuition and fees
| Admission fee | 400 PLN |
| Price (possibility of payment in two installments each 6 250 PLN each) | 12 500 PLN |
| Price with discount for Kozminski University students and graduates (possibility of payment in two installments each 5 625 PLN) | 11 250 PLN |
| Price with discount for payment in full | 12 000 PLN |