IMETICS, a small Romanian CRO founded in 2013, has the people, resources and culture to respond to pharmaceutical and biotechnology clients’ drug development challenges. We are one of a small group of organizations with the capability and expertise to conduct clinical trials and develop projects on a local basis. We can provide clinical development services on a stand-alone basis or as part of an integrated “full service solution”. IMETICS is a Contract Research Organization based in Tirgu Mures, Romania, with experience and expertise in bioequivalence trials, and other phase I-IV trials. Our role in the pharma industry is partnering with clients to accelerate time-to-market, control development costs and reduce risk on investment. We have provided services to several Pharmaceutical and Biotech companies, helping them develop and launch some of the most important drugs of our time.Our services include strategy development, clinical trials management, data management, biostatistical analysis, regulatory affairs, training and publishing. 

Experts in Medical Monitoring

IMETICS has a great expertise in the field of Safety Medical Monitoring. Our team supports the entire clinical trial, from protocol design to study close out for CTP design i.e.: assessing the inclusion and exclusion criteria, weighing the efficacy and safety assessments of the protocol, defining safety endpoint, adverse event assessment and collection, or study discontinuation criteria.

We are providing on a regular basis medical expertise for trial oversight and safety concerns. We are prepared to answer inclusion and exclusion questions from investigative sites, CRAs, and study teams, and to answer questions specific to the protocol during the site start-up process. Our usual activity covers coordinating with other personnel on the study to ensure that information is consistent, addressing safety issues across the study from sites and the study team,actively interacting with investigative sites and acknowledging and providing guidance for when a subject needs to be unblinded due to medical emergency. Our expertise allow reviewing line listings for coded events to verify Medical Dictionary for Regulatory Activities (MedDRA) consistency.

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