OCT is happy to provide services in bioequivalence trials conduct. OCT experts have experience in more than 50 bioequivalence studies. OCT has long term collaboration with a phase I unit and analytical laboratories in Russia. The phase I unit we work with has a license for volunteers’ hospitalization. The site is one of the biggest sites in Russia. The capacity of the site is 35 beds. The analytical laboratories we work with have state-of-the art equipment to provide a full range of bioanalytical services. They use the following techniques in bioanalytical studies:
- LC–MS (liquid chromatography–mass spectrometry)
- HPLC (high performance liquid chromatography)
- CE–MS (capillary electrophoresis–mass spectrometry)
On September 1, 2010 a new law came into force – law #61 as of April 12, 2010. According to the new legislation “On medicines circulation” in Russia generic medicinal products intended for medical use are subject to trials for bioequivalence and/or therapeutic equivalence in Russia. OCT can assist generics companies to get their drugs registered in Russia. We provide a full package of services to bring your generics products to Russian market.
We can perform pre-clinical studies of generic drugs, which are requested by the Russian Regulations. We perform pre-clinical studies at the leading pre-clinical sites in Russia.
OCT can prepare a full package of study documents necessary to perform bioequivalence studies:
- Study Protocol
- Case Report Forms (CRFs)
- Informed Consent Forms (ICF)
- Investigator’s Brochure (IB)
OCT will assist you with clinical study submission to the Regulatory Authorities in Russia.
Phase I unit we work with will be responsible for
- Healthy volunteers recruitment
- Drug administration
- Laboratory tests
- Blood sampling
- Hopsitalization
- Catering
- Emergency care
OCT will perform routine monitoring visits to make sure that the study is performed in accordance with GCP and relevant guidelines.
Bioanalytical part will be performed at one of our partner laboratories:
- Samples collection
- Drug/metabolite assay development and validation
- Drug/metabolite analysis
- Data Analyses
OCT will perform Quality Assurance and Quality Check at every stage of the study. At the end of the study our clients receive final report which will enable them to get their drugs registered in Russia.
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