CRO- Contract Research Organization
In order to service our clients and offer the true "From Molecule to Market", we can offer Contract Research Organization (CRO) services through one of our valued partners. This truly makes ACIC the ideal partner of choice as we can offer full support throughout the entire life of your project, or just be an integral part of certain aspects.
Our partner company has invested over one million Euros in building a modern Drug Evaluation Center in order to carry out studies of pharmaceutical bioequivalence and Stage I clinical studies. The center has an area of 1150 m2 with two distinct working sectors - a clinical unit and an analytical unit.
The clinical unit has 32 completely equipped beds, emergency and monitoring equipment, and qualified personnel: pharmacologists and internal medicine and emergency specialists.
Using the latest generation of equipment, the analytical unit develops bioanalytical methods by high-pressure liquid chromatography with UV detection, and fluorescent and mass spectroscopy.There is an extensive list of analytical methods validated in compliance with community legislation and FDA regulations. When requested, the bioanalytical determination laboratory can also develop methods for further analyses.
The center has its own laboratory for metabolite synthesis necessary for the bioequivalence studies.
The new bioequivalence center has its own quality insurance system during the clinical and analytical phases and the bioanalytical determination laboratory is certified Good Laboratory Practice (GLP) by the National Drug Agency. In order to develop bioequivalence studies, the facility has 600 healthy volunteers registered in the data base.
Please contact us to see how we can help move your project along the complex road to market.
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