Bioequivalence studies

The increase of bioequivalence studies in Russia is the result of several factors, which include:

  • Blockbuster drugs patent expiry. The global pharmaceutical market has been witnessing a change as many patents of key blockbuster drugs have expired within last few years.
  • Adaptation of Pharma 2020 Strategy. The strategy is stimulating local production of national generics, creation of import substitution market mechanisms
  • The Russian legislation. The Federal Law "On Circulation of Medicines" requires local studies conduct for generic drugs to be registered in Russia.
The network of centers for clinical research Medical Technologies conducts bioequivalence studies on the premises of IHB RAS.

Medical Technologies has needed infrastructure and equipment for bioequivalence studies conduct in accordance with international standards.

The following services within bioequivalence studies are provided by Medical Technologies:

  • Study subject enrollment
  • Study subject screening
  • Study procedures conduct
  • Study subjects reimbursement

Medical Technologies have an excellent group of investigators, medical staff (including physicians and nursers) and study coordinators. More than 50 employees with solid experience guarantee that all listed services are provided in due time and with good quality. We are ready to meet client's needs and requirements.

Medical staff have experience working with all types of data capture, including electronic CRFs and subject diaries. Our staff know Standard Operating Procedures of Medical Technologies very well. We work with different types of archives and accountability logs. We are ready to adopt our procedures and forms in accordance with Sponsor's SOPs.

Out team experience includes dozens of bioequivalence trials and also includes experience of bioequivalence trials conduct at different sites.

Medical Technologies is an ideal partner for bioequivalence trials because it offers the following advantages:

  • A big database of volunteers who participated in a clinical trial at least once
  • Subject enrollment within several days (depending on the number of volunteers)
  • Quick subjects screening
  • Hospitalization of all subjects in one day. The unit has 60 beds.
  • Established procedures of blood sampling and team work
  • Standardized environment for clinical trials
  • Standardized meals for volunteers
  • Payments to volunteers (bank transfer)
  • Dedicated team of investigators and nurses
  • Data entry operators who complete CRFs in a short period of time
  • Capability of conducting complex procedures
  • Documents expertise before study initiation