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.
Open days
Dzień Otwarty Online "KOŹMIŃSKI ZDROWIE"
About KU
Key Highlights
Entirely in English – ideal for international participants
Online weekend sessions (Saturday–Sunday), optimized for working professionals
2 semesters, 197 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. Foundations of Clinical Trials
- Drug development phases, trial types, pediatric and non-commercial trials
2. Legal & Ethical Frameworks
- GCP, GMP, GLP, GDPR, EU CTR, ethics committee procedures
3. Project & Site Management
- Feasibility, budgeting, contracting, communication skills
4. Patient-Centered Research & Pharmacovigilance
- Recruitment, retention, clinical pharmacology, adverse event reporting
5. Quality & Compliance
- Documentation standards, audits and inspections, risk of fraud
6. Data Management & AI
- Data systems, AI-supported monitoring, innovations in clinical tech
7. Trial Operations
- CRA role, monitoring strategy, site visit execution, remote work protocols
8. Capstone Project
- Collaborative project with real-case analysis and defense
Total number of teaching hours: 197, including integration activities and assessments (one teaching hour = 45 minutes)
Classes are organized in English, in the form of dedicated weekend sessions. The course is divided into thematic modules, each delivered during successive academic sessions. The sessions are conducted in an online format, making it easier for participants from outside Poland to attend.
The lectures take place
- Saturdays 8.45am - 5.30pm
- Sundays 8.45am - 3.45pm
Community
Leading lecturers
Łukasz Wiech is a physician and public health specialist with over 15 years of experience in clinical research and extensive expertise in healthcare management. He is a graduate of the MBA for Medical Professionals at Kozminski University.
He currently serves as Medical Director at the Trialmed network of clinical research sites in Poland, where he is responsible for developing the medical team, ensuring research quality, and safeguarding patient safety. As a leader of healthcare programs at Kozminski University, he has educated more than 2,000 graduates, enhancing their competencies in healthcare management and clinical research. Being also the founder and promoter of the WE! Are Clinical Research community, he pursues the mission of building a development platform for clinical research professionals in Poland and across Europe.
He is a certified trainer of the advanced simulation game SysTeamsChange®, supporting managers and organizations in developing practical skills for implementing and managing change, particularly in the healthcare sector. His research focuses on the use of simulation games as educational tools in management processes, combining theory with practice and setting new directions for development in this field.
Łukasz Wiech believes that the future of healthcare depends on education, innovation, and collaboration, and he works at the intersection of science, business, and clinical practice to create value for patients, professionals, and organizations.
Admission procedure
- Admission is based on the order of application until March 15th September, 2026. The planned date of launch of the group is October 2026.
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
Additional discounts offered by the university cannot be combined with the single payment discount
| 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 |
BANK ACCOUNT Admission fee should be transferred to the following account: Akademia Leona Koźmińskiego 03-301 Warszawa, ul. Jagiellońska 57/59 BANK PEKAO SA w Warszawie 20 1240 1024 1111 0010 1646 0637
Tuition should be paid to an individual account number provided during admission to the program.
Anyone interested in receiving an INVOICE, please contact Ms. Agnieszka Fabiańska: [email protected]
We kindly inform that editions are launched with the specified number of participants, allowing proper group dynamics.