Founded in 2013 as a specialized consulting firm, IMETICS has evolved into a Contract Research Organizations (CRO) based in Romania.
IMETICS started its activity in R&D as a CRO principally operating in the Clinical Pharmacology field both in Romania and in the EEC.
IMETICS plans, co-ordinates, monitors and reports Non-clinical, Bioequivalence, Phase II, III and IV clinical studies in Romania and Europe according to the International Standard ICH on “Good Clinical Practice” adopted by the National Authority of Medicine and Medical Devices Romania and/or updated EMEA Guidelines.
The presence of CRA Monitors allows IMETICS to accurately manage and co-ordinate clinical studies. IMETICS also utilizes local Clinical Monitors to accurately manage non therapeutic observational trials, at a reduced costs. IMETICS Clinical Monitors have a degree in biomedical sciences and are trained through periodic courses. All monitors familiar with our regularly reviewed Standard Operating Procedures. This ensures that they use a “common language” when reporting on any study.
Monitor meetings are regularly held during the start-up phase and at least monthly during the course of the trial. These meetings are essential to rapidly identify any problems and to maintain the high standard of quality that is the hallmark of all IMETICS studies.
The IMETICS organizational structure guarantees thorough management of Adverse Events, especially of Serious Adverse Events, in accordance with the new NAMMD and EEC regulatory requirements.
IMETICS also has a Quality Assurance Service that operates independently of the Clinical Research Department, reporting directly to the General Manager. This service is essential for careful Quality Control of data management and clinical study related procedures.
IMETICS has Standard Operating Procedures (SOPs) which cover all the aspects of clinical trial from planning to management or the flexibility to operate utilizing the Sponsors’ SOPs.
IMETICS provides Data Management and Statistical Analysis services with a staff of fully trained and experienced personnel.
Our strategic divisions are:
- Clinical Research Division
- Consulting Division