Kynetyx HT is a British-Romanian Contract Research Organization, specialized in performing high quality Phase I and bioequivalence studies.
Kynetyx HT was founded in 2006 by a group of professionals in pharmaceutical-medical field with broad experience in conducting Phase I clinical studies, developing and validating bioanalytical methods, in the field of data and project management, pharmacokinetics and biostatistics, regulatory, drug and business development etc. For our detailed services please follow the link.
We are located in Cluj-Napoca; one of the major university center in Romania and provide full services in Phase I trials. Our headquarter is a privately owned, independent, fully integrated organizational structure in one site, having full control on our studies.

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PHASE I UNIT

*EU-GCP conform clinical unit
*26 dedicated beds for subjects
*Highly experienced clinical team
*Internal emergency care unit
*Collaboration with local ICU, hospitals and certified clinical laboratories

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BA LABORATORY

*GLP certified bioanalytical facility
*LC-MS/MS equipments
*Highly experienced chemists
*Method development and validation
*Bioanalytical samples assay
*EU, FDA, Sponsor specific development and validation

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QA, QC, MONITOR

*GCP & GLP Compliance;
*Highly experienced Quality Assurance, Quality Control and clinical Monitor team
*Internaly developed SOPs
*Internal, external audits
*Validated quality processes
*CIR accreditation
*ISO certification

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PK&STAT, DM

*Pharmacokinetic and data analysis
*Study design and randomization
*Biostatistics with validated softwares
*Highly experienced team
*PK&Stat Report generation
*Data management