Training, Education & Capacity Building

Training, Education & Capacity Building

From free certified online programs (GCP, CRA, RBQM, disease literacy) to corporate curricula on regulations, epidemiology and indication trainings — delivered with 29 years of field experience.

Capabilities

Key Features

Each capability is delivered by experienced specialists with deep domain expertise.

GCP Training Programs

Comprehensive Good Clinical Practice training ensuring regulatory compliance.

Investigator Training

Specialized training programs on study protocols and regulatory requirements.

Capacity Building Initiatives

Programs designed to strengthen clinical research capabilities and infrastructure.

Regulation Trainings

Clinical research legislation (RG 32203) article by article, plus eCTD and bioequivalence regulations.

Epidemiology & Biostatistics

Study design, sampling, bias and the statistical literacy every research team needs.

Indication Trainings

Site-specific curricula in the indication your team studies — oncology, haematology, cardiology and beyond.

Training Catalog

Program catalog

Online programs are free and certified on the BİRİK training platform; corporate curricula are delivered by the Omega Training Academy tailored to your team.

Free Certified 16 modules · 25 hours

GCP Foundation Training

ICH-GCP principles and TİTCK regulations; the complete clinical research process across 16 modules.

Free Certified EN 6 modules · 25 hours

GCP E6(R3) Training — ICH-Based (EN)

English GCP program built on the current ICH E6(R3) guideline.

Free Certified 6 modules · 3 hours

GCP E6(R3) Refresh (Certificate Renewal)

A focused renewal training on the E6(R3) changes that keeps GCP certificates current.

Free Certified 5 modules · 8 hours

Introduction to Clinical Research

The clinical research lifecycle, its parties and core concepts — for newcomers to the field.

Free Certified 4 modules · 8 hours

Fundamentals of Ethical Approach in Clinical Research

Research ethics principles, volunteer rights and the ethical decision-making framework.

Free Certified 4 modules · 6 hours

Standardization Course for Ethics Committee Structuring

Establishment, operation and standardization requirements of ethics committees.

Free Certified 3 modules · 7.5 hours

Regulatory Affairs Specialization

TİTCK submission processes, the regulatory framework and regulatory strategy.

Free Certified 4 modules · 8 hours

Pharmacovigilance and Drug Safety Specialization

Monitoring, ICSR processes and safety reporting, including SUSAR and periodic reports.

Free Certified 10 modules · 11 h 40 min

CRA Certification Program

The full CRA role from site visits to reporting; a certified mastery program.

Free Certified 12 modules · 10 hours

CRA Monitoring Training

Site initiation, periodic and close-out visits; management of monitoring findings.

Free Certified EN 10 modules · 11 h 40 min

CRA Certification Program — English

The English edition of the CRA certification program — for international teams.

Free Certified EN 12 modules · 10 hours

CRA Training Program — English

The English edition of the field monitor training.

Free Certified 4 modules · 5 hours

Clinical Research Nurse Program

Volunteer follow-up, IMP handling and the research nurse’s responsibilities.

Free Certified 3 modules · 3 hours

Research Pharmacist Program

Receipt, storage, dispensing and return of investigational products at the pharmacy.

Free Certified 5 modules · 15 hours

Role-Based GCP Simulation for Site Staff

GCP simulation with role-specific scenarios for the site team.

Free Certified 5 modules · 12 hours

Role-Based GCP Simulation for CRO/Sponsor Staff

GCP simulation tailored to sponsor-side and CRO roles.

Free Certified 3 modules · 6 hours

Risk-Based Quality Management (RBQM)

Risk-based monitoring, quality tolerance limits and critical process parameters.

Free Certified 3 modules · 7 hours

Clinical Data Management (CDM) & EDC

From the data management plan to EDC entry; data quality and query management.

Free Certified 3 modules · 6 hours

Clinical Project Management (CPM) Leadership

Planning, budgeting and stakeholder management of clinical projects.

Free Certified 3 modules · 7 hours

Cell & Gene Therapy (CGT) Clinical Research

Trial design, manufacturing and logistics requirements of advanced therapies.

Free Certified 3 modules · 7.5 hours

AI Applications in Clinical Research

Signal detection, AI-assisted monitoring and data science in clinical research.

Free Certified 9 modules · 24 hours

CAR-T Cell Therapy Program

Aligned with the EBMT/EHA curriculum; from basic science to CRS/ICANS management in 24 hours.

Free Certified 4 modules · 8 hours

Advanced Clinical Research Program

Advanced design, analysis and regulatory topics for experienced professionals.

Corporate · On demand

Clinical Research Legislation — Article by Article

A practical walkthrough of Regulation RG 32203: every article with case examples.

Corporate · On demand

eCTD and Submission Readiness

The eCTD module structure, compilation and agency submission process.

Corporate · On demand

Bioequivalence and BY/BE Regulations

BY/BE study design, facility requirements and the regulatory framework.

Corporate · On demand

Epidemiology and Study Design Series

From observational to interventional designs; sampling, bias and confounding.

Corporate · On demand

Biostatistics Fundamentals

Statistical literacy for clinical researchers, from p-values to power analysis.

Corporate · On demand

Indication Trainings — Site Specific

A curriculum specific to the indication your site studies (oncology, haematology, cardiology…).

Corporate · On demand

Medical Writing: Protocol and ICF

Writing and readability of protocols, consent forms and participant information.

Free Certified 12 modules · 7 hours

Myeloproliferative Neoplasms (MPN)

Pathophysiology and clinical management of MPNs.

Free Certified 12 modules · 7 hours

Haemophilia A and B

Literacy on diagnosis, treatment and follow-up of haemophilia.

Free Certified 12 modules · 6 hours

Systemic Lupus Erythematosus (SLE)

The clinical spectrum of SLE and modern treatment approaches.

Free Certified 13 modules · 6 hours

Thyroid Diseases

Diagnosis and management of thyroid dysfunction.

Free Certified 12 modules · 5 hours

Atrial Fibrillation

AF diagnosis, risk management and anticoagulation.

Free Certified 12 modules · 6 hours

Atherosclerosis and CVD

Atherosclerosis pathophysiology and cardiovascular risk.

50+

disease-literacy programs

Haematology (17) · Rheumatology (7) · Oncology (6) · Infectious (5) · Neurology · Cardiology · Endocrine · Respiratory · Gastro · Metabolic · Ophthalmology

Browse the full catalog

Need a tailored program for your site or team?

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

How We Deliver Training, Education & Capacity Building

1

Kick-off alignment on objectives, risks, timelines, and required evidence package.

2

Detailed execution plan with role clarity, communication cadence, and milestone governance.

3

Delivery with continuous quality checks, documentation control, and corrective action loops.

4

Readiness close-out with final outputs, handover package, and next-phase roadmap.

Engagement Outcomes

  • •Faster preparation and approval cycles with fewer avoidable queries.
  • •Higher data and documentation consistency across study milestones.
  • •Improved inspection and audit readiness across teams and sites.
  • •Clear visibility on risks, decisions, and timeline-critical dependencies.

Ready to Get Started?

Contact our team to learn how Omega CRO can support your clinical research needs.