Clinical research across Eastern Europe
Integrated operational support from feasibility and start-up through monitoring, data activities and study close-out.
Discuss your study
IRIS CRO supports phase I–IV studies in the pharmaceutical, biotechnology, medical-device and cosmetics sectors. The scope can be tailored to each sponsor and protocol.
Accurate and timely country- and site-level feasibility is essential to study planning. IRIS CRO maintains country-level knowledge of experienced sites, recruitment potential, patient retention and data quality. Candidate sites are assessed against protocol requirements and sponsor expectations.
Site selection considers documented recruitment performance, access to the required patient population, qualified staff, suitable facilities, patient-retention capabilities and the ability to produce reliable data.
Experienced start-up and regulatory specialists coordinate country requirements, regulatory authorities and ethics committees, document collection, translations, site contracts and study timelines.
Clinical Research Associates are assigned according to relevant study and therapeutic-area experience, including cardiology, pulmonology, oncology, surgery, rheumatology, dermatology, neurology, infectious diseases, hematology, endocrinology, medical devices and cosmetics. Training and development are overseen by company management. Dedicated procedures and experienced personnel are available for blinded and unblinded activities, including drug-management oversight and on-site or remote unblinded monitoring.
Project managers work directly with clients to lead studies, support planning and set-up, coordinate trial processes, manage budgets and timelines, oversee risks and maintain agreed quality standards.
Support can include study design and outlines; Clinical Investigation Plans for pilot, pivotal and post-market medical-device studies; phase I–IV clinical study protocols and amendments; informed consent forms; investigator brochures; and case report forms.
Services can include Data Management Plans and Data Validation Plans; EDC configuration, validation, edit-check programming and account management; User Acceptance Testing; data review and cleaning; medical review support; discrepancy and outlier identification; cross-checks and logic checks; query generation and resolution; risk-based monitoring support; pre-database-close activities; soft and hard lock; dataset assembly; and Blinded Review Meeting preparation and conduct.
Third-party vendor coordination may cover customs clearance, depot and logistics services, medical translation and patient transportation.
Regulatory specialists support document preparation, submission processes, authority and ethics interactions, query coordination and country-specific follow-up.
Experienced clinical research professionals can be provided across the company’s service areas to complement sponsor and study teams.
Every client and study is treated individually. Personnel receive regular training, and work is performed in alignment with applicable international requirements and guidance, including ICH-GCP and relevant EU legislation.
The table below retains the planning information from the original website, edited for clarity. Timelines are indicative and must be reconfirmed against the current regulation, authority practice and individual study pathway before they are used for planning.
| Country / review | Medicinal products | Medical devices | Planning note |
|---|---|---|---|
| Georgia — local ethics committee | 3–4 weeks | 3–4 weeks | Ethics approval is included in the national regulatory submission package. |
| Georgia — regulatory authority | 21 working days for review, plus up to 15 working days for query responses | 21 working days for review, plus up to 15 working days for query responses | Confirm the current pathway and document sequence for the individual study. |
| Latvia — ethics/regulatory review | CTIS procedure: validation and assessment periods apply; the original planning estimate stated a maximum of 106 days including queries | Approximately one month in the original planning estimate, excluding clock stops for questions | Medicinal-product submissions use CTIS. Medical-device pathways and timelines depend on study classification. |
| Ukraine — ethics committee | Approximately 4 weeks | Approximately 4 weeks | Regulatory, operational and safety feasibility must be reconfirmed before planning. |
| Ukraine — regulatory authority | Approximately one month plus query time | Approximately two weeks plus query time | Regulatory, operational and safety feasibility must be reconfirmed before planning. |
| Poland — ethics/regulatory review | CTIS procedure; the original planning estimate stated up to 106 days including queries | Approximately one month plus query time | Medicinal-product submissions use CTIS. Medical-device timelines depend on the study pathway. |