Knowledge and Technology Transfer Office (KTTO) Clinical Research Coordination Unit Research

The CRCU is a specialized subdivision of KTTO dedicated to supporting clinical research infrastructure at YSMU and affiliated hospitals.

Mission:

• To ensure high-quality, ethically sound clinical trials in partnership with sponsors, CROs, and investigators.
• To promote the translation of scientific discoveries into clinical, diagnostic, and therapeutic innovations.
• To support researchers, clinicians, and students in navigating the innovation pipeline from idea to implementation.

Key Responsibilities:

• Central coordination of all ongoing and upcoming clinical trials
• Feasibility assessments and site readiness evaluations
• Ethics submission support and regulatory compliance
• Investigator and staff training (GCP, SOPs)
• Budget planning and contract negotiation
• Patient recruitment strategies and database coordination

For Sponsors & CROs

CRCU provides comprehensive support for the initiation and management of clinical trials at YSMU and affiliated sites.

Services include:

• Feasibility assessments and site selection
• Regulatory and ethics submission support
• Contract negotiation and budget planning
• Study start-up and operational support

Sponsors and CROs are invited to contact KTTO to initiate collaboration and discuss study opportunities.

For Researchers & Students

KTTO supports researchers and students throughout the research and innovation lifecycle.

Support includes:

• Guidance on protocol development and study design
• Organise training programs and educational resources
• Opportunities for involvement in ongoing clinical research projects
• Ethics submission support and regulatory compliance

Regulatory & Ethics Framework

All clinical research activities at YSMU are conducted in accordance with international and national standards.

• Compliance with ICH-GCP (Good Clinical Practice) guidelines
• Adherence to local regulatory requirements and Ministry of Health policies
• Oversight by independent ethics committees
• Commitment to patient safety, data integrity, and ethical research conduct

Research Infrastructure & Facilities

YSMU provides a strong clinical and academic environment to support high-quality research.

• Access to affiliated hospitals and specialized clinical departments
• Established patient data registry for research and recruitment
• Multidisciplinary expertise across key therapeutic areas
• Infrastructure to support multicenter and international trials

Milestones and Achievements

• Establishment of a centralized patient data registry
• Successful collaboration with international sponsors and CROs
• Ongoing multicenter clinical trials in allergology, cardiology, oncology, neurology, endocrinology, and rare diseases

Why Collaborate with YSMU?

• Experienced and GCP-certified investigators and staff
• Access to a large and diverse patient population
• Strong academic and hospital infrastructure
• Transparent ethics review and regulatory pathways
• Supportive environment for contract and logistics management

Allergology and Immunology Department

The Department of Clinical Immunology and Allergology at N1 “Heratsi” Hospital Complex is actively engaged in clinical research. The department has demonstrated consistent involvement in both sponsor-initiated and investigator-initiated studies, contributing to the advancement of research in allergology and immunological diseases.

Between 2015 and 2025, the department has conducted multiple clinical studies, including Phase III clinical trials and observational research, focusing on conditions such as hereditary angioedema, bronchial asthma, allergic rhinitis, drug allergies. urticaria, and atopic dermatitis.

The department has participated in international multicenter clinical trials in collaboration with leading pharmaceutical companies, including Octapharma, Chiesi Farmaceutici, and Church & Dwight.

Current research activities include ongoing clinical trials and observational studies, while previously completed studies have contributed to improving diagnostic approaches and treatment strategies in allergology.

The department also demonstrates strong research capacity in patient recruitment and management, supported by access to a diverse patient population with a high prevalence of allergic and immunological conditions.

Key Research Focus Areas

Bronchial asthma

Allergic rhinitis

Hereditary angioedema

ACE inhibitor–induced angioedema

Urticaria

Atopic dermatitis

Drug allergies

Clinical Studies (2015-2025)

• An ongoing Phase III sponsor-initiated clinical trial titled the “Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks”, led by Armine Hakobyan, is being conducted between 2024 and 2027 with support from Octapharma. Enrolled patients up to now 11.
• The TRECOS Asthma Study, a Phase III sponsor-initiated clinical trial led by Armine Hakobyan and sponsored by Chiesi, was conducted between 2023 and 2025.
• Another ongoing investigator-initiated observational study, Bradykinin Angioedema Biomarkers, led by Zaruhi Kalikyan, is being carried out between 2025 and 2028 and is state-funded.
• NAREG Registry (Autoimmune Diseases)is a longitudinal, prospective, multicenter Armenian registry focused on systemic autoimmune and autoinflammatory diseases, incorporating an integrated biobanking component. Within its framework, comprehensive clinical data c0ollection and biological sample storage are conducted, including dedicated efforts for patients with hereditary angioedema, enabling advanced research and improved understanding of these conditions. The project is ongoing, the PI is Armine Hakobyan.
• Previously, the department completed an investigator-initiated observational study titled Drug Allergy in Armenia, also led by Zaruhi Kalikyan, conducted between 2018 and 2020 with state funding.
• In 2022, a Phase III sponsor-initiated clinical trial titled Sterimar Allergic Rhinitis Study, led by Armine Hakobyan and sponsored by Church & Dwight, was successfully completed, enrolling 59 patients (ClinicalTrials.gov Identifier: NCT05506709).

Contact Person

Name: Armine Hakobyan

Email: arminehakobyan.v@gmail.com

Study team

Zaruhi Kalikyan

Mariam Movsisyan

Armen Grigoryan

Meline Suqiasyan

Mary Khachatryan

The Educational Unit of KTTO is responsible for developing and delivering structured training programs aimed at strengthening research capacity and professional competencies across YSMU.

Key Responsibilities:

• Design and organize training programs in clinical research, research project management, and standard operating procedure (SOP) development
• Identify training needs and prepare comprehensive training plans for clinicians, clinician-scientists, study nurses and students
• Develop, implement, and continuously improve educational courses tailored to different professional groups, supporting capacity building in clinical research and innovation

Projects organized by Educational Unit

Labship

Labship is a competitive, short-term training program organized by the Knowledge and Technology Transfer Office at Yerevan State Medical University in collaboration with COBRAIN Center. Selected students participate in an intensive, hands-on course combining lectures and laboratory experience across multiple research facilities. The program aims to introduce participants to modern experimental methods, research ethics, and practical skills in biomedical science

Brain bee, Brain Bee Armenia and Georgia Competition 

Trainings

Grant proposal writing

Ethics in Academic and Clinical Research

“Knowledge Transfer” spring school

Launch of a VR-Based Research Project in Anatomy Education at YSMU

Digital SORT IT in Armenia

YSMU is proud to host the SORT IT program, a WHO/TDR-supported Structured Operational Research and Training Initiative. This program builds operational research capacity among healthcare professionals and researchers, strengthens adherence to international research standards, and promotes global collaboration in public health and clinical research. Participation in SORT IT provides researchers and students with structured training in designing, conducting, and publishing operational research studies.

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