Pioneering Progress: Understanding the Nuances of Innovative Phase 1 Clinical Trial Design
Schedule
Payment by credit card or bank transfer
BOOK & PAY DEADLINE: July 24, 2025
Early bird discount 10% for those who register by 13th of July 2025 No VAT refund. Corporate discounts: 5% for over 3 participants 10% for over 5 participants For more information please contact us at info@avantyo.com or 0726 840 456
COURSE DESCRIPTION
Pioneering Progress: Understanding the Nuances of Innovative Phase I Clinical Trial Design is a specialised training programme focused on the foundational and advanced aspects of early-phase clinical research.
With a spotlight on Phase I trials—including First-in-Human studies, dose-escalation strategies, and innovative protocol designs—this course provides participants with a deep understanding of how early-stage clinical trials are structured, regulated, and executed in today’s rapidly evolving research environment.
The programme offers a comprehensive overview of the clinical trial landscape, encompassing preclinical study requirements, regulatory frameworks, medicinal development timelines, and cost considerations. Each element is addressed in relation to current industry expectations and methodological rigour.
Additionally, the course explores emerging trends such as adaptive trial designs (e.g., umbrella, basket, and platform trials). It highlights the growing role of early-phase centres, while also examining the implications of recent regulatory changes prompted by trial failures.
Participants will gain insights into:
- The critical transition from preclinical to clinical research
- Regulatory and ethical requirements for Phase I trials
- Global Good Manufacturing Practice (GMP) standards relevant to investigational product development
- Strategies for improving trial design, patient safety, and data quality during early-stage development
This course is ideally suited to clinical research professionals, investigators, and healthcare practitioners seeking to enhance their knowledge and leadership in the innovative design and implementation of Phase I clinical trials.
ONLINE INSTRUCTOR-LED COURSE
Organizers: Avantyo Institute of Clinical Research
Location: Online
Duration: 1-day sessions for 8 hours each day
Training days: July 25, 2025
Training time: From 10 AM GMT+2
Language: English / Romanian
Trainer: Dr. Catalina Sarbu
Attendance only by online reservation. Booking available after registering on this site.
WHY ATTEND OUR CRA ADVANCED COURSE?
Expert Trainers: Learn from experienced professionals like Catalina Sarbu, who bring real-world insights and expertise to the training.
Interactive Learning: Engage in interactive sessions, case studies, and discussions to enhance your understanding the nuances of innovative phase 1 Clinical Trial Design
Flexible Learning Options: Attend the course online via Zoom, making it accessible to professionals worldwide.
Certification: Upon completion, receive a certification. Participants will be able to download their Participation Certificates directly from their accounts on www.avantyo.com
For discounts and assistance, or if you wish to be placed on a waiting list for the next course, or require any additional information, please contact us at diana.lupu@avantyo.com (+40 0726 840 456). Be sure to mention your specific educational requirements in clinical trials.
This training is tailored for experienced professionals and medical practitioners involved in the early phases of clinical research, particularly those engaged in the planning, execution, and oversight of Phase I clinical trials.
Ideal participants include:
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Senior Clinical Research Associates (CRAs): Professionals seeking to expand their expertise in early-phase trial design and execution, including First-in-Human and bioequivalence studies.
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Clinical Trial and Project Managers: Individuals responsible for coordinating clinical trial operations, ensuring protocol adherence, and managing study timelines and budgets.
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Regulatory Affairs Specialists: Experts who ensure trials comply with evolving international regulatory frameworks, particularly in the context of early-phase innovations.
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Data Managers: Professionals tasked with managing and ensuring the integrity of complex datasets generated during early-phase trials.
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Principal Investigators (PIs) and Sub-Investigators: Physicians and clinical leaders who oversee and conduct Phase I trials, with responsibilities including participant recruitment, ethical conduct, investigational product administration, and regulatory compliance.
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Quality Assurance Auditors: Individuals ensuring that early-phase trials meet Good Clinical Practice (GCP) standards and are prepared for audit.
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Healthcare Practitioners: Medical professionals, including doctors and nurses, who are entering or progressing within clinical research roles and contributing to the development of new medical treatments through ethical and compliant research.
This course is especially valuable for those in leadership or decision-making positions within clinical research teams, as well as those interested in mastering innovative trial designs—such as umbrella, basket, and platform trials—and understanding the international regulatory and Good Manufacturing Practice (GMP) environment surrounding early medicinal development.
Dr. Catalina SARBU Secretary General of the Romanian Association of CROs (ACCSCR) Romania
- 2022-2025 Secretary General of the Romanian Association of CROs (ACCSCR) Romania
- 2000-2022 Director of the Romanian Representative office of PAREXEL Nederland BV
- Former President of the CRO Association in Romania (ACCSCR)
- General Practitioner – Center of Hematology, Ploiesti, Romania
- Saint Antoine University, Paris, France - Hematology and Blood Transfusion, 1-year courses
- University of Medicine and Pharmacy, Bucharest, Romania - Medical Doctor Degree
For previous events, please access one of the following links.
