从免费认证在线课程到法规、流行病学和适应症培训的企业课程。
每项能力由具有深厚领域专业知识的经验丰富的专家提供。
确保监管合规的全面GCP培训。
关于研究方案和监管要求的专业培训项目。
旨在加强临床研究能力和基础设施的项目。
逐条讲解临床试验法规（RG 32203），以及 eCTD 和生物等效性法规。
研究设计、抽样、偏倚以及研究团队所需的统计素养。
按团队研究方向定制的课程——肿瘤、血液、心脏等。
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
No programs under this filter.
We design and deliver regulation, epidemiology, indication and role-based trainings tailored to your organization — backed by 29 years of field experience.
Request a training对目标、风险、时间表和所需证据包进行启动协调。
详细的执行计划，包括角色明确、沟通频率和里程碑治理。
通过持续质量检查、文档控制和纠正措施循环进行交付。
准备就绪收尾，包括最终输出、交接包和下一阶段路线图。