IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

Services

The efficacy and safety of original drugs is evaluated during clinical trials of Phase II and III.

In research therapeutic Phase II clinical trials efficacy and dosing in patients with specific disease are evaluated.

In confirmatory therapeutic Phase III trials primary endpoint are to demonstrate / confirm efficacy and to evaluate the safety profile for determining the ratio of the expected benefit to the possible risks of the drug.

Medical expertise and effective planning are key factors of clinical development success. Thorough monitoring ensures the quality of data and guarantees the authenticity of results.

IPHARMA resources and experience within clinical trials help to optimized the terms of the trial and reduce the risks:

  • Own scientific-research platform and medical expertise

  • Solid experience in using adaptive clinical design in various therapeutic areas

  • Centrally-controlled clinical trials support in EEU countries

Clinical trials services (Phase II-III):

  • documents development

  • regulatory support

  • project management

  • clinical monitoring

  • medical monitoring

  • pharmacovigilance

  • data management, biostatistics

  • logistics and warehouse

  • central and bioanalytical laboratories

  • quality assurance

List of the MoH approvals for the conduct of clinical trials - Phase II and Phase III:

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