About Us
Kynetyx HT is a British-Romanian contract research organization, specialized in performing high quality bioequivalence trials. Kynetyx HT was founded in 2006 by a group of professionals in pharmaceutical field, with experience in conducting bioequivalence trials, bioanalytical method development and validation, data and project management, pharmacokinetics and biostatistics, regulatory, drug and business development etc.
Kynetyx HT is located in Cluj-Napoca, Romania; one of the major university center in Romania with aprox 70.000 students annually. Our vision is to become a team with our Sponsor, taking over the “headache” concerning bioequivalence trials and providing high quality, reliable results in time.
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26 beds, fully equipped, GCP inspected independent clinical unit with highly trained and experienced clinical investigators assure that your bioequivalence clinical studies are conducted in a well controlled environment on healthy human subjects. |
A state-of-the-art, GLP certified bioanalytical facility and the expertize of the analytical staff makes possible to develop, validate bioanalytical methods and analyze biological samples coming from your bioequivalence clinical trials. |
Internal Quality Assurance unit with well trained monitors assures that the conduct of your bioequivalence clinical trials is compliant with the GCP & GLP guidelines, internal SOPs, EU regulatory requirements. |
PK & Statistics, Data Management unit with highly experienced staff designs the best protocol and CRF for your bio-equivalence trials and guarantees the compliance of the trial master file with the regulatory agencies requirements. |