IPHARMA is a contract research organization specialized in conducting clinical trials of investigational drugs in the Russian Federation and the EAEU.

  • Preclinical studies
  • Early Phase clinical trials
  • Pilot trials and registration
  • Drug registration
  • Pharmacovigilance
  • Bioequivalence trials
  • Audits
  • Trainings
IPHARMA is a member of ChemRar High-Tech Center group of companies and MD Medical Group. IPHARMA is an accredited partner of Skolkovo Innovation Center.
Our services
IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

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Study documentation
  • Clinical trial program development
  • Clinical trial documentation development (IB, Protocol, ICF, Patient Materials)
Project management
  • Site and Investigator contract development
  • Payment schedule development
  • Training program and materials development
Clinical Monitoring
  • Site identification and feasibility
  • Site qualification, initiation, monitoring, and close-out visits
  • Oversight of communication with Local Ethics Committees (approvals and notifications)
  • Collection of essential documents and TMF maintenance
  • Source data verification, CRF review, and query resolution and tracking
  • Tracking of enrollment, subject progress
  • Tracking of protocol deviations
  • Communication with clinical sites
Medical monitoring
  • Medical monitoring and support to clinical sites and project teams
  • Interfacing with Data Safety Monitoring Boards
  • Interfacing with the Sponsor’s medical department
  • SAE reporting, AE listings, and laboratory alert and protocol deviations review
Data Management and biostatistics
  • DM and Statistical analysis plan
  • eCRF and database development
  • Data review and query generation
  • Statistical analysis
  • BDR
Pharmacovigilance
  • Safety plan development
  • Safety precautions
  • SUSAR Report Preparation
  • Post authorization pharmacovigilance
Regulatory Submissions
  • Clinical Trial Insurance
  • Registration dossiers submission
  • Clinical Trial Application to RA
  • Import/Export licenses
  • Clinical trial documentation consideration monitoring
  • Legislation amendments monitoring
  • Legal analysis
  • Study documents translation management and notary certification
IPHARMA results
According to the information-analytical bulletin issued by Association of Clinical Trial Organizations (ACTO), IPHARMA topped the list of CROs by the number of local trials and bioequivalence trials.

100+

CTA approvals

150+

drug products in pipeline

20+

drugs registered

50+

medical devices registered

180+

protocols written

820+

clinical sites

6 500+

healthy volunteers enrolled

11 250+

patients enrolled

Pharmacovigilance
If you would like to report an adverse drug reaction, you can do this by phone: 
+7 (495) 276-11-43, e-mail sae@ipharma.ru or by filling out the online form on the website.

IPHARMA is now collecting information on
Normacor®, Levopront, OKI ACT and Avifavir.

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