Feasibility

Accurate, rapid, professional country/site-level feasibility assessment is essential for successful clinical trial progress, completion.

IRIS CRO has huge country level databases with experienced,
motivated, high recruitment potential sites. Databases updates on daily basis. Only sites with experienced staff, acceptable enrolment, high patients' retention and data quality can be considered as suitable.

Site Selection

Choosing the right site is critical to a successful clinical trial. Sites must have an accurate history of accurately patient enrolment in the required quantity, site staff and procedures must be professional to ensure proper patient retention, sites must be able to provide quality data.

Site Start up

IRIS CRO highly professional Start-up &Regulatory Specialists with more than 5 years of experience are well educated in country regulatory requirements, meet deadlines, helping the sponsor work with Regulatory Authorities and Ethics Committees, coordinating translations and negotiate contracts with sites by following timelines.

Clinical Monitoring

IRIS CRO Clinical Research Associates are highly professional, with more than 3-4 year experience in clinical trials, are experienced in Cardiology, Pulmonology, Oncology, Surgery, Rheumatology, Dermatology, Neurology, Infectious Diseases, Hematology, Endocrinology, Medical Devices, Cosmetics, are assigned for projects by their experience, demonstrate high levels of site management skills. Company’s management follow CRAs training development process to be sure to have the high-level service.

IRIS CRO ‘has dedicated procedures and an experienced team for unblinded monitoring, including managers who manage the parts of trials related to unblinded drug management, and CRAs with vast experience in both onsite and remote unblinded monitoring.

Medical Writing for medicines and medical devices

We can provide Study design and study outline development, development of Clinical Investigator Plan (CIP) for medical devices: pilot, pivotal, and postmarketing studie, Phase I-IV Clinical Study Protocol development and amendments to them, Informed Consent Form (ICF) development, Investigator's brochure development, Case Report Form (CRF) creation.

Data management services

Data management planning (Data Management Plan, Data Validation Plan), EDC system management (OnlineCRF or other EDC’s): configuration, validation, , edit-check programming, account management, etc., performing User Acceptance Test, Data review and data cleaning (medical monitoring, identification of the data discrepancies and outliers, cross-checks, logic checks, query generation/resolution), performing risk-based monitoring, pre-DB closure activities, soft lock, hard lock, Datasets formation and assembly, Blinded Review Meeting preparation and conduct.

Vendor Management

IRIS CRO is experienced with the third party Vendors selection such as customs clearance service, depot service, translation of medical text any complexity, transport patients.

Regulatory Service 

IRIS CRO regulatory specialists are high-level professionals available to provide exceptional services, are with excellent knowledge of regulatory documents preparation/submission processes, with successful outcomes.

Flexible Resourcing services

IRIS CRO provides experienced and professional staff for all company’s services.

Quality 

For IRIS CRO every client is unique. Quality management is one of the main aspects of the work of IRIS CRO. All company’s staff receives trainings in regular basis on high priority. Our clients can be sure of the high quality of provided service. Company is working by following applicable international regulatory requirements and guidelines (i.e. ICH-GCP, and/ or EU-Directives).

We are responsible for

 ▶ Organization of clinical trials IV in Pharma, Biotech, Medical Device and Cosmetics industries 
 ▶ Purchase, storage and distribution of pharmaceuticals 
 ▶ Customs clearance service
 ▶ Translation of medical texts of any complexity
 ▶ Transport of patients.

We offer portfolio of services which can be tailored to meet the individual needs of each client.