Trainings
We offer specialized training programs designed for professionals involved in clinical research and life sciences. Our trainings combine regulatory knowledge, practical experience, and real-life case studies, ensuring participants gain both theoretical understanding and hands-on insight.
All courses are delivered by experienced clinical research professionals and can be tailored to different levels of expertise – from entry-level to advanced roles.
Our Training Areas
ICH GCP R3
Comprehensive training covering the latest updates to ICH Good Clinical Practice (R3). The course focuses on the principles of quality by design, risk-based approaches, data integrity, and participant safety, with practical guidance on implementation in day-to-day clinical trial operations.
Clinical Trials of Medical Devices
Training dedicated to clinical investigations of medical devices in accordance with applicable EU and international regulations. The course addresses study design, regulatory requirements, safety reporting, documentation, and the roles and responsibilities of sponsors and investigators.
Clinical Trials of In Vitro Diagnostic Medical Devices (IVD)
Specialized training focused on performance studies of in vitro diagnostic medical devices under IVDR. Participants gain an understanding of regulatory pathways, study documentation, ethical considerations, and compliance requirements specific to IVD clinical performance studies.
Clinical Trials of Medicinal Products
In-depth training covering the full lifecycle of clinical trials involving medicinal products – from early-phase studies to post-marketing trials. Topics include regulatory submissions, safety reporting, study conduct, and inspection readiness.
Clinical Trial Regulations and Legal Framework
An overview of the legal and regulatory environment governing clinical trials, including EU Clinical Trial Regulation (CTR), MDR, IVDR, and national requirements. The training provides clarity on compliance obligations and regulatory expectations across different trial types.
Clinical Trial Monitor (CRA)
Practical training for current and aspiring Clinical Research Associates (CRAs). The course covers monitoring responsibilities, source data verification, site management, communication with investigators, and preparation for audits and inspections.
Clinical Trial Assistant (CTA) – Introduction to the Role
An introductory course designed for individuals starting their career in clinical research. The training explains the role of a Clinical Trial Assistant, daily responsibilities, collaboration with study teams, and essential documentation and systems used in clinical trials.
Clinical Trial Documentation
Training focused on essential documents in clinical trials, including the Trial Master File (TMF), Investigator Site File (ISF), and regulatory documentation. Participants learn best practices for document management, quality control, and inspection readiness.
Clinical Trial Start-Up
A practical course covering the clinical trial start-up phase, from feasibility and site selection to regulatory and ethics submissions, contract negotiation, and site activation. The training highlights common challenges and proven strategies to accelerate study start-up while maintaining compliance.