Working with Synergy: The Fastest, and Friendliest,

CRO in Russia

August 4, 2016

John Barker

COO, Synergy Research Group

barker@synrg-pharm.com

THANK YOU! • Thank you for asking for more information

about Synergy Research Group.

• This slide deck is meant to be able to “stand alone,” to be passed around to different groups within your company, and to answer a lot of questions without being “presented.”

Working with Synergy • Conducting clinical research in Russia has never been easier thanks to

Synergy Research Groups expertise proven in over 200 clinical trials.

• Let Synergy lead you through our simple 3 Step Model. It is as EASY as counting One, Two, Three!

Just tell us exactly what you want.

Review Synergy’s detailed Proposal and Gantt chart and make any changes you wish.

Sign one and only one contract approving one and only one budget, and sit back and relax.

Synergy will guide you every step of the way, take accountability and run with the program for you, keeping you informed with a live web-dashboard and with weekly updates and meetings at the times of your choosing, adapting and managing as you wish as the trial continues to a successful conclusion on time, and on budget.

What Will Your Contract with Synergy Include?

The answer is EVERYTHING and SIMPLICITY. • Using either your SOPs or Synergy’s, Synergy’s staff of highly experienced

PM’s, CRA’s, CTL’s, Data Managers, Biostatisticians, Safety Monitors and Regulatory Specialists will do all translations, prepare all CRFs, prepare all Informed Consents, contract with all sites, contract with drug storage and shipping providers, educate all participating site staff, meet all regulatory requirements, gain all approvals, manage and pay all sites, manage drug importation and storage, monitor sites, prepare and submit timely monitoring reports, continue to refine and educate sites based on trends from monitoring results, regularly review data for quality and adapt as necessary, manage SAE reporting, collect and clean data, provide interim analysis, analyze data, close sites, dispose of left over study medications, and provide clean data and/or complete analysis.

Synergy’s Top 5 Reasons to Conduct Clinical Studies in Russia

1. High concentrations of eligible patients clustered around major medical institutions

2. Ease and speed of Regulatory approvals that mirror Europe’s Regulatory requirements

3. High quality data as verified by both FDA and EMEA audit histories of Russian sites

4. Costs for conducting clinical studies in Russia can be as much as 60% less than the costs in the USA or Europe for the same studies

5. Simplicity with Synergy: One contract. One Budget. Synergy will take accountability and guide you every step of the way

Click here to see a 3-min video

Thank You Notes

About Synergy: quick facts

• Private Russian company;

• Conducted over 200 clinical trials;

• 130+ full time employees today;

• Offices in Moscow, St. Petersburg, Almaty, Kiev;

• Home-based CRAs in different regions of Russia, Ukraine, Kazakhstan, Belarus and Georgia;

• Orange Paper™ publisher

Click here to see a 1.5-min video

Synergy: today in Synergy

• Over 24,000 patients in ongoing clinical trials

• 66 ongoing studies

• Most of our PMs are MDs, and half of them are also PhDs.

• Most of our CRAs are MDs, most of the remaining CRAs are pharmacists. 20% of CRAs are PhDs.

Synergy: modular solutions or full service

• Study Design;

• Medical Writing;

• Regulatory Approval;

• Project Management;

• Monitoring;

• Data Management;

• Biostatistics;

• Safety Management etc.

Synergy: study experience by phase

• BE Studies: 8% • Non-Interventional Studies: 12% • Epidemiologic Studies: 2% • Phase I Studies: 2% • Phase II Studies: 7% • Phase III Studies: 51% • Phase IV Studies: 18%

More details on our Online Dashboard

Click!

Synergy: Regulatory affairs

• Average approval time is 43 days;

• Import/Export license is 30% faster than industry’s average*

* Data provided by the Russian CRO Association

SOPs

QMS

Training

Quality Management System

Training Center Standard

Operating Procedures

21 Sponsor Audits since 2010 and no Major or Critical findings

Average findings per audit: Critical: 0 Major: 0 Minor: 4

HIGH DATA QUALITY FDA Audit Findings: USA and Russia

Source: FDA. Data available for Inspections ending October 1, 2008 through March 31,

2014

No Actions Indicated 73%

No Actions Indicated 52%

Voluntary Actions Indicated 27%

Voluntary Actions Indicated 43%

Official Action Required 5%

RUSSIA

USA

Mean Per Patient Costs Worldwide Vs. Russia

as of January 2015

Phase Distribution of Studies Conducted in Russia, All Indications

Phase I 5%

Phase II 13%

Phase III 76%

Phase IV 6%

Patient Distribution of Studies Conducted in Russia, All Indications

Oncology 20%

Endocrinology 16% Pulmonology

13%

Musculoskeletal diseases

12%

Circulatory system deseases

10%

Ophthalmology 6%

Neurology 4%

Others 19%

Summary • Clinical trials are alive and well in Russia, demonstrated

by the strong approval rates by both the FDA and EMEA

• High concentrations of patients are available

• Costs are significantly lower in Russia

• Quality is high

With Synergy it is as easy, and simple, as counting

www.synrg-pharm.com