In order to be irreplaceable one must always be different. Coco Chanel (1883 – 1971)

2. In order to be irreplaceable one must always be different. Coco Chanel (1883 – 1971)

3. Who are we… BIOCARD – is a full service CRO and a full cycle logistics specialist with 23 years of experience.

4. Worked with 14 out of top 20 pharma companies in the world • Biocard is the oldest CRO’s in Russia (eg. 1988/89 we ran the first trial in Post Soviet Russia for Austrian company Ebewe)  • over 10 years exclusively represented Covance in Russia

5. Participated in more than 350 (incl. 320 system and site audits) multi-center phase II-III trials; ran more than 20 BE and phase I studies • We can name many examples, when Biocard saved international multicentre trials • 80% of our studies completed recruitment ahead of schedule.

6. Our therapeutic expertise… On average 25 multi-center studies per year. 19% Оncology 9% Anaestesiology 1% ORL 3% Endocrinology 17% Cardiology 1% Diagnostics 7% Pulmonology 3% Infections 17% Neurology 1% Rheumatology 5% Psychiatry 3% Gynecology

7. What we offer for multicenter international/ local trials • Study Conduct • Project management • Site Management • Monitoring (paper and eDC) • Pharmacovigilance • Data Management • Biostatistics • Storage and distribution of investigational drugs and trial-related materials • Central Laboratory Management • Close-Out • Closing centers • Disposing of products • Regulatory Notification • DB Lock • Statistical Analysis • Integrated Final Report • Setup • Feasibility • Medical writing, SAP, DMP • Site selection • Translation • Insurance • Regulatory • Import and export of clinical supplies and biological samples • Setup and conduct of investigator meetings • IVRS

8. We think that feasibility is one of the key selection factors, influencing outcome of the study. Defining the “Optimal Site” Investigator interest and experience in clinical trials • High patient recruitment potential Willingness to pre-screen existing patients Ability to perform all protocol requirements Sufficient and dedicated site staff Acceptable contract process Past proven record of recruitment and quality

9. But why we think that we stand out from the crowd?

10. We are not afraidof challenges! To start with...

11. We are proud of our regulatory knowledge Local Country Start Up Expertise Local Regulatory expertise Close relationship with local Regulatory Authorities In depth understanding of local practices and procedures Local language communication Strategic regulatory advice/consultancy throughout project life

12. We offer full cycle of clinical logistics • IMPORTATION • RECEIPT • AND • CHECK • EXPORTATION • DESTRUCTION • STORAGE • RETURN • AND RECALL • LABELING • DISTRIBUTION

13. Unmatched customs clearance performance Importation/exportation of all kinds of study materials (drugs, lab Kits, CRF’s, ECG machines, etc.) Your consulting assistant in obtaining import/export licenses Customs clearance under 24 hours!

14. OWN COURIER SERVICE Special temperature and humidity controlled vehicles Experienced and trained staff Accountability at every stage of the process

15. We can provide all types of storage Privately owned, validated storage facility designed and equipped for separate storage of different study materials Equipped to provide for different temperature requirements: +15 … +25°c / +2 … +8°c / -20 ± 5°c / -85°c Control of temperature and humidity by centralized computer system Uniquely developed Warehouse Management System (WMS) with stock tracking capability (client web access) Company’s own staff (pharmacist) to manage storage, distribution & drug accountability Monitored access and top class security system.

16. Collaboration with most experienced local units and analytical labs (local and EU) Own DB of volunteers Medical writing Regulatory: preparation of the submission package and close follow-up of the approval process Import/Export Monitoring/QC Independent Audit Final Report We know how to run bioequivalence studies For local drug registration purpose and for registration in EU

17. Our Proposition for BE Studies in Russia

18. Benefits • Reported study data is accurate, complete and verifiable from source documents • Source documents are adequate; lab and instrumental methods are authentic • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP and the applicable regulatory requirements • You don’t get trapped in a “bottleneck” like the rest of the market

19. We have relevant experience

20. How do you know if we are the right partner?

21. We have all the right ingredients Speed Quality Experience Communication Customer Focus BIOCARD Full Cycle Problem Solving Innovation

22. Quality in Everything We Do SOPs governing all our procedures Our track record Independent quality assurance Well structured disaster recovery plan ISO 9001-2008(Biocard Logistics) Pharmacy license (Biocard Logistics)

23. Our team is accustomed to work in a fast paced environment. We deliver on our promises without compromises. Our rule is to exceed your expectations. You get fast results

24. We are cost effective Flexible and ready satisfy your expectations without putting too much stress on your budget.

25. We focus on our customers! Our basic strategy is a clear execution of customer’s requirements. But we aspire “to foresee customer’s wishes”. Give us a chance and present yourself with ease of mind!

26. Our Contacts Give us a call, and our representative will be glad to answer your questions! Germany Markstrasse 5, Frankfurt/Main, Germany, D-60388 Russia Karamyshevskayanaberezhnaya 44, Moscow, Russia, 123423 Oleg Baykov Business Development T. +7 499 199 2680 M.+7 916 519 5006 ob@biocardcro.com www.biocardcro.com KaramushevskayaNaberezhnaya 44, Moscow, Russia, 123423 Markstrasse 5, Frankfurt/Main, Germany, D-60388