От бесплатных сертифицированных онлайн-программ до корпоративных курсов по регуляторике и эпидемиологии.
Каждая возможность предоставляется опытными специалистами с глубокой экспертизой.
Всестороннее обучение Надлежащей клинической практике для регуляторного соответствия.
Специализированные программы по протоколам и регуляторным требованиям.
Программы для укрепления возможностей и инфраструктуры клинических исследований.
Регламент по клиническим исследованиям (RG 32203) статья за статьёй, а также eCTD и биоэквивалентность.
Дизайн исследования, выборка, смещения и статистическая грамотность.
Программы под конкретное показание: онкология, гематология, кардиология и др.
Online programs are free and certified on the BİRİK training platform; corporate curricula are delivered by the Omega Training Academy tailored to your team.
ICH-GCP principles and TİTCK regulations; the complete clinical research process across 16 modules.
English GCP program built on the current ICH E6(R3) guideline.
A focused renewal training on the E6(R3) changes that keeps GCP certificates current.
The clinical research lifecycle, its parties and core concepts — for newcomers to the field.
Research ethics principles, volunteer rights and the ethical decision-making framework.
Establishment, operation and standardization requirements of ethics committees.
TİTCK submission processes, the regulatory framework and regulatory strategy.
Monitoring, ICSR processes and safety reporting, including SUSAR and periodic reports.
The full CRA role from site visits to reporting; a certified mastery program.
Site initiation, periodic and close-out visits; management of monitoring findings.
The English edition of the CRA certification program — for international teams.
The English edition of the field monitor training.
Volunteer follow-up, IMP handling and the research nurse’s responsibilities.
Receipt, storage, dispensing and return of investigational products at the pharmacy.
GCP simulation with role-specific scenarios for the site team.
GCP simulation tailored to sponsor-side and CRO roles.
Risk-based monitoring, quality tolerance limits and critical process parameters.
From the data management plan to EDC entry; data quality and query management.
Planning, budgeting and stakeholder management of clinical projects.
Trial design, manufacturing and logistics requirements of advanced therapies.
Signal detection, AI-assisted monitoring and data science in clinical research.
Aligned with the EBMT/EHA curriculum; from basic science to CRS/ICANS management in 24 hours.
Advanced design, analysis and regulatory topics for experienced professionals.
A practical walkthrough of Regulation RG 32203: every article with case examples.
The eCTD module structure, compilation and agency submission process.
BY/BE study design, facility requirements and the regulatory framework.
From observational to interventional designs; sampling, bias and confounding.
Statistical literacy for clinical researchers, from p-values to power analysis.
A curriculum specific to the indication your site studies (oncology, haematology, cardiology…).
Writing and readability of protocols, consent forms and participant information.
Pathophysiology and clinical management of MPNs.
Literacy on diagnosis, treatment and follow-up of haemophilia.
The clinical spectrum of SLE and modern treatment approaches.
Diagnosis and management of thyroid dysfunction.
AF diagnosis, risk management and anticoagulation.
Atherosclerosis pathophysiology and cardiovascular risk.
50+
Haematology (17) · Rheumatology (7) · Oncology (6) · Infectious (5) · Neurology · Cardiology · Endocrine · Respiratory · Gastro · Metabolic · Ophthalmology
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We design and deliver regulation, epidemiology, indication and role-based trainings tailored to your organization — backed by 29 years of field experience.
Request a trainingСтартовое согласование целей, рисков, сроков и пакета доказательств.
Детальный план с распределением ролей, графиком коммуникации и управлением этапов.
Выполнение с непрерывным контролем качества, управлением документами и корректирующими действиями.
Завершение с финальными результатами, пакетом передачи и планом следующей фазы.
Свяжитесь с нашей командой, чтобы узнать, как Omega CRO может поддержать ваши клинические исследования.