© 2019 IPHARMA

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

Services

IPHARMA Quality Assurance System is based on the strict compliance with Russian laws and Good Clinical Practice (ICH-GCP).

 

IPHARMA’s auditors have international certificates and may offer quality assurance services for your future and ongoing projects. We have practical experience in carrying out inspections held in Russian clinical sites shared with regulatory authorities of Russia and the USA.

IPHARMA LLC is ready to offer the quality assurance services. Quality assurance staff have international and local audits experience of many years. 

Quality Assurance services include:

  • Site audits

  • TMF and project management system audit

  • Business processes audit

  • Vendor audit (CRO, labs, depots) 

  • Data management and biostatistics companies

  • Trainings and documents preparation

  • Accompaning Audit

  • Standard operation procedure development

Each audit program may be individually designed, depending on design features and customer requirements. The result of each audit contains the detailed description of actions performed and all nonconformances exposed.

In addition to the audits performance, our staff can participate in the development and coordination of the corrective and preventive actions plan in relation to the results of the audits performed. We are also glad to offer the staff trainings and the paperwork for regulatory inspections, as well as the advisory support during the regulatory authorities inspections.