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IPHARMA Clinical Services in
Russia and EAEU
IPHARMA LLC
CRO in ChemRar group
IPHARMA is a well-established CRO that manages clinical trials in Russia
and EAEU.
population over 183 million people
centralized healthcare system
 Partner of Skolkovo Innovative center
 Clinical division of ChemDiv Inc (USA)
 Clinical branch of ChemRar group (Russia)
Full cycle of clinical development from
early phase trials to registration and post-marketing PV.
QUICK FACTS 2012-2018
Innovative products in clinical
pipeline
Protocols written
Regulatory approvals
Clinical sites
Healthy volunteers enrolled
Patients enrolled
Original drugs filed for
registration
68+
80+
53+
240+
542+
8
2180+
THERAPEUTIC AREAS
Registration
No. Studies BE Phase I Phase II Phase III Phase IV NIS
Cardiology 5 3 1 1
Dermatology 3 2 1
Endocrinology 6 3 2 1
Gastroenterology 5 1 2 2
Neurology 7 3 2 2
Oncology 15 3 7 2 3
Otolaryngology 6 2 4
Psychiatry 4 3 1
Pulmonology 6 1 2 1 2
Rheumatology 4 3 1
Surgery 4 2 2
Urology 4 2 1 1
Virology 22 1 9 8 2 1 1
TOTAL 91 9 38 17 19 5 3
CLIENTS
CLIENTS: COMPANIES AND STARTUPS OF CHT "CHEMRAR"
GENERAL MANAGEMENT
Chief Operating Officer
MEDICAL N=11
Medical
Director
QPPV
Medical
Advisors
Medical
Associate
Assistant
CLINICAL N=30
Director of
ClinOps
Project
Managers
Senior CRA
CRA
Project
Administrators
DATA
MANAGEMENT N=5
DM Director
Programmer
Data Manager
DM Speacialist
Biostatistician
REGULATORY N=2
Director of
Regulatory
Affairs
Regulatory
Manager
QA DEPARTMENT
N=3
QA Director
Training & QA
Managers
ADMINISTRATIVE
N=3
Administrative
Director
Senior
Administrator
Office
Administrator
BD DEPARTMENT
N=5
BD Director
BD Manager
Commercial
Manager
Marketing
Manager
IPHARMA QUALIFIED STAFF (N=61)
Natalia Vostokova, PharmD,Chief Operating Officer
• Graduated from the Moscow Medical Academy in 2004
• In Clinical Research Since 2004 (CRA  Project Manager  Commercial
Manager  COO)
• Phase 1-3 Clinical Trials in Russia and Ukraine (Russian, US, and
European Pharma and Biotech Companies)
• 30+ Audits and 4 FDA Inspections
• Leading IPHARMA LLC since 2012
Julia Trakhtenberg, MD, PhD, Medical Director
• Graduated from the Moscow Medical Academy in 1997
• Residency and Post-Graduate Study in Endocrinology (1997 to 2006); PhD
in 2006
• In Clinical Trials since 2001 (Sub-Investigator  Medical Monitor  Medical
Director)
• Phase 1-3 Clinical Trials in Endocrinology, Ophthalmology,
Gastroenterology, Pulmonology, Hematology, Cardiovascular diseases
• Head of the Medical Department of IPHARMA since 2012
Oksana Karavaeva, MD,Director of Clinical Operations
• Graduated from Smolensk Medical Academy in 1998
• Residency in Endocrinology (1998 to 2001)
• In Clinical Trials Since 2001 (Medical Expert  CRA  Project Manager 
Director ClinOps)
• Phase 1-3 Trials in Neurology, Oncology, Psychiatry, Pediatrics,
Endocrinology, CV, GI, Urology, and Ophthalmology
• Head of the Clinical Department of IPHARMA since 2012
Pavel Kholkin, DM Director
• Graduated from the State University of Management in 1996 and the
Project Management Institute in 2016
• In Clinical Research Since 2015 (Data Manager  Programmer)
• Phase 1-3 Trials in Oncology, Pediatrics, Immunology and Dermatology
• Head of IPHARMA DM Department since 2018
Konstantin Semenov, MD, QA Director
• Graduated from the St. Petersburg Medical Academy in 1996
• Residency in Psychiatry (1996 to 1999)
• In Clinical Research Since 2000 (CRA  Auditor  QA Director)
• More than 15 Years of Clinical Trial Auditing (Clinical Sites, CRO, Labs,
Depots), Reception of Audits and FDA Inspections
• Trained in Russia and UK
• Head of IPHARMA QA Department since 2012
Diana Sapozhnikova, PhD, Director of Regulatory Affairs
• Graduated from the Moscow Medical Academy in 2003; PhD in 2006
• In Clinical Trials since 2003 (Medical Associate  Medical Director 
Regulatory Affairs)
• Phase 1-4, BE in a wide range of therapeutic areas
• Head of the Regulatory Affairs Department of IPHARMA since 2018
Vyacheslav Rogov, Administrative Director
• Law school of Moscow Economic and Legal University in 2010
• Over 10 years in clinical research (jurisprudence, audit, compliance)
• Member of the Ethics Committee
• Head of the Expert Group 2.2-2.4, Laboratory of program management and
projects development in the field of Living Systems
• Head of IPHARMA Administrative Department since 2017
Anna Rashina, BD Director
• Graduated from the Belgorod State University in 2005 and the State
University of Management in 2010
• In Clinical Research Since 2004 (Assistant  PM  Head of PM group 
BD Director)
• More than 12 Years as PM at Central Lab (Phase 1-4, BE, Post-Marketing
trials), 50+ Audits
• Head of IPHARMA BD Department since 2016
Natalia Vostokova, PharmD
Chief Operating Officer
Mobile: +7 (926) 098-36-33
NV@ipharma.ru
IPHARMA LLC (ChemRar group)
5, Nobel street, Moscow, 143026, Russia
Tel.: +7 (495) 276-11-43
Fax: +7 (495) 276-11-47
Web: www.ipharma.ru
We will be happy to conduct a complimentary feasibility for your study
and provide you with the best clinical trial solution.
Anna Rashina
Business Development Director
Mobile: +7 (903) 578-33-23
AAR@ipharma.ru

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IPHARMA presentation eng

  • 1. IPHARMA Clinical Services in Russia and EAEU IPHARMA LLC CRO in ChemRar group
  • 2. IPHARMA is a well-established CRO that manages clinical trials in Russia and EAEU. population over 183 million people centralized healthcare system  Partner of Skolkovo Innovative center  Clinical division of ChemDiv Inc (USA)  Clinical branch of ChemRar group (Russia)
  • 3. Full cycle of clinical development from early phase trials to registration and post-marketing PV. QUICK FACTS 2012-2018 Innovative products in clinical pipeline Protocols written Regulatory approvals Clinical sites Healthy volunteers enrolled Patients enrolled Original drugs filed for registration 68+ 80+ 53+ 240+ 542+ 8 2180+
  • 4. THERAPEUTIC AREAS Registration No. Studies BE Phase I Phase II Phase III Phase IV NIS Cardiology 5 3 1 1 Dermatology 3 2 1 Endocrinology 6 3 2 1 Gastroenterology 5 1 2 2 Neurology 7 3 2 2 Oncology 15 3 7 2 3 Otolaryngology 6 2 4 Psychiatry 4 3 1 Pulmonology 6 1 2 1 2 Rheumatology 4 3 1 Surgery 4 2 2 Urology 4 2 1 1 Virology 22 1 9 8 2 1 1 TOTAL 91 9 38 17 19 5 3
  • 5. CLIENTS CLIENTS: COMPANIES AND STARTUPS OF CHT "CHEMRAR"
  • 6. GENERAL MANAGEMENT Chief Operating Officer MEDICAL N=11 Medical Director QPPV Medical Advisors Medical Associate Assistant CLINICAL N=30 Director of ClinOps Project Managers Senior CRA CRA Project Administrators DATA MANAGEMENT N=5 DM Director Programmer Data Manager DM Speacialist Biostatistician REGULATORY N=2 Director of Regulatory Affairs Regulatory Manager QA DEPARTMENT N=3 QA Director Training & QA Managers ADMINISTRATIVE N=3 Administrative Director Senior Administrator Office Administrator BD DEPARTMENT N=5 BD Director BD Manager Commercial Manager Marketing Manager IPHARMA QUALIFIED STAFF (N=61)
  • 7. Natalia Vostokova, PharmD,Chief Operating Officer • Graduated from the Moscow Medical Academy in 2004 • In Clinical Research Since 2004 (CRA  Project Manager  Commercial Manager  COO) • Phase 1-3 Clinical Trials in Russia and Ukraine (Russian, US, and European Pharma and Biotech Companies) • 30+ Audits and 4 FDA Inspections • Leading IPHARMA LLC since 2012 Julia Trakhtenberg, MD, PhD, Medical Director • Graduated from the Moscow Medical Academy in 1997 • Residency and Post-Graduate Study in Endocrinology (1997 to 2006); PhD in 2006 • In Clinical Trials since 2001 (Sub-Investigator  Medical Monitor  Medical Director) • Phase 1-3 Clinical Trials in Endocrinology, Ophthalmology, Gastroenterology, Pulmonology, Hematology, Cardiovascular diseases • Head of the Medical Department of IPHARMA since 2012
  • 8. Oksana Karavaeva, MD,Director of Clinical Operations • Graduated from Smolensk Medical Academy in 1998 • Residency in Endocrinology (1998 to 2001) • In Clinical Trials Since 2001 (Medical Expert  CRA  Project Manager  Director ClinOps) • Phase 1-3 Trials in Neurology, Oncology, Psychiatry, Pediatrics, Endocrinology, CV, GI, Urology, and Ophthalmology • Head of the Clinical Department of IPHARMA since 2012 Pavel Kholkin, DM Director • Graduated from the State University of Management in 1996 and the Project Management Institute in 2016 • In Clinical Research Since 2015 (Data Manager  Programmer) • Phase 1-3 Trials in Oncology, Pediatrics, Immunology and Dermatology • Head of IPHARMA DM Department since 2018
  • 9. Konstantin Semenov, MD, QA Director • Graduated from the St. Petersburg Medical Academy in 1996 • Residency in Psychiatry (1996 to 1999) • In Clinical Research Since 2000 (CRA  Auditor  QA Director) • More than 15 Years of Clinical Trial Auditing (Clinical Sites, CRO, Labs, Depots), Reception of Audits and FDA Inspections • Trained in Russia and UK • Head of IPHARMA QA Department since 2012 Diana Sapozhnikova, PhD, Director of Regulatory Affairs • Graduated from the Moscow Medical Academy in 2003; PhD in 2006 • In Clinical Trials since 2003 (Medical Associate  Medical Director  Regulatory Affairs) • Phase 1-4, BE in a wide range of therapeutic areas • Head of the Regulatory Affairs Department of IPHARMA since 2018
  • 10. Vyacheslav Rogov, Administrative Director • Law school of Moscow Economic and Legal University in 2010 • Over 10 years in clinical research (jurisprudence, audit, compliance) • Member of the Ethics Committee • Head of the Expert Group 2.2-2.4, Laboratory of program management and projects development in the field of Living Systems • Head of IPHARMA Administrative Department since 2017 Anna Rashina, BD Director • Graduated from the Belgorod State University in 2005 and the State University of Management in 2010 • In Clinical Research Since 2004 (Assistant  PM  Head of PM group  BD Director) • More than 12 Years as PM at Central Lab (Phase 1-4, BE, Post-Marketing trials), 50+ Audits • Head of IPHARMA BD Department since 2016
  • 11. Natalia Vostokova, PharmD Chief Operating Officer Mobile: +7 (926) 098-36-33 NV@ipharma.ru IPHARMA LLC (ChemRar group) 5, Nobel street, Moscow, 143026, Russia Tel.: +7 (495) 276-11-43 Fax: +7 (495) 276-11-47 Web: www.ipharma.ru We will be happy to conduct a complimentary feasibility for your study and provide you with the best clinical trial solution. Anna Rashina Business Development Director Mobile: +7 (903) 578-33-23 AAR@ipharma.ru