cromos™ pharma general presentation

proprietary and confidential

GENERAL PRESENTATION

where the patients are


WHO WE ARE

• Privately owned leading independent contract research organization

in Eastern Europe

• Established in 2004

• Solid financial standing, debt-free

• Steady regional geographical expansion over the last 3 years with

special focus on countries often overlooked by bigger CRO

(Armenia, Belarus, Georgia)


GEOGRAPHICAL COVERAGE

Coverage (offices or home-based)

Office, Clinical Operations

Office, Finance

Moscow

Smolensk

Tbilisi

Dublin

Kyiv Prague

Budapest


OUR REGIONS Reasons for attraction • High subject recruitment rates

• High subject retention and low drop-

out rates

• High quality of clinical data

• Motivated study investigators

• Competent and experienced clinical

staff

• Competitive costs

• Growing markets


HIGH RECRUITMENT RATES Case Study • Pivotal international phase III

oncology (breast cancer) study

• Over 20 countries participated

• 19 active sites in Russia

• Over 350 pts enrolled in Russia within

12 months

• Over 30% of worldwide enrolment

• Some sites enrolled 40-50 pts

• 3 sponsor audits conducted to date

• No critical findings


WHY CROMOS™ PHARMA?

• “No patients = no payments” initiative

• Own depots in Russia, Ukraine,

Georgia and Belarus

• Core clinical staff are MDs and PhDs

key to running complex studies

• Intimate knowledge of local clinical

markets and its regulatory hurdles

fast and smooth regulatory approval

process

• Full professional liability coverage

from Lloyd’s of London

• Diligent and frequent communication

with the sponsor you are always

abreast of your study’s progress

• Large database of qualified clinical

trial sites fast selection of best sites

for your study

• Regulatory inspections (including FDA

inspection in 2017) and audits that

attest to the highest quality of data


International

clinical trials

• Regulatory affairs

(RA approvals,

import / export

licenses)

• Project

management

• Site selection

• Monitoring

• Study drug and

supplies logistics

Registration

services

• Development of a

drug / device

registration

roadmap

• One-stop-shop for

local registration

studies (incl. BE)

• Preparation of drug

/ device

registration dossier

Post-marketing

services

• Non-interventional

programs

• Patient registries

• Phase IV studies

Local depots

and logistics

• Depots in Russia,

Ukraine, Belarus

and Georgia

• Comparator

sourcing

• Named patient

programs


OUR SERVICES

• Expertise in local medical and

country-specific requirements

• Regulatory activities

• Medical writing

• Clinical monitoring and related

services

• Feasibility and sites selection

• Initiation visits, ongoing monitoring visits,

close-out visits

• Project management

• Medical management

• Data management services (via

preferred providers)

• Biostatistics services

• Full custody of logistics in clinical trial

materials

• Supply of comparator drugs for clinical

trials

• Established execution algorithm of

contracts and payments to sites


MEDICAL MONITORING SERVICES

• Medical Monitors

• vast expertise in protocol

development

• consultations for investigators on

protocol inquiries

• medical data and coding review

• targeted eligibility verification of

KOLs

• review of diagnostic reports

• review of study documents

(Protocol, IB, ICF, CSR and

narratives)

• disease-specific trainings for study

teams


STUDY MANAGEMENT • Model A – full project management

• Cromos Pharma is responsible for all study activities with regular study status reporting

to the Client

• Model B – local project management

• Client’s project manager provides general study management, Cromos Pharma

appoints local study coordinator who manages all activities and reports to Client’s

project manager

• Model C – monitoring only

• Study is managed by Client’s project manger, Cromos Pharma provides monitoring

and local support only


RECENT EXPERIENCE by therapeutic areas

N = 91, as of 21 March 2017

(only projects involving monitoring)


RECENT EXPERIENCE Post Marketing Studies (phase IV and

observational)

N = 18, as of 21 March 2017

(only projects involving monitoring)


OVERALL MEDICAL DEVICE EXPERIENCE • Ophthalmic lens for cataract in Russia

• 1 site – 25 pts

• Dental implant in Russia

• 1 site – 5 pts

• Test for oncology screen in Russia

• 3 sites where samples were

collected, 1 central lab testing

• Stent for aortic malformation in Israel

• 1 site, 5 pts

• Vaginitis – registration in Russia with

local testing

• HIV rapid test – Georgia, Russia,

Belarus

• Subarachnoidal hemorrage in Czech

Republic

• 3 sites, 8 pts

• Cardiovascular stent in Poland and

Czech Republic

• 4 sites, 8 pts


EMPLOYEES • Majority of core clinical team posses

terminal degrees [MD, PhD, PharmD,

etc]

• Over 70% of CRAs are MDs

• Approximately 60% are “cum laude”

graduates

• Pool of prescreened CRAs

• Our approach: the same team for the

lifetime of your study

• Turnover rate under 5%


QUALITY MANAGEMENT SYSTEM • In-house Quality Assurance

Department

• Own standard operating procedures

• Regular internal audits

• Regular co-monitoring visits for every

project

• Vendor audits

• Intensive training program (via LMS)

• Clinical staff (PM, CRA initial, follow-up

and advanced, CTA)

• Clinical Project Management

• Systems Theory Practice

• SOPs – for CROs and Sponsors

• International and local CA requirements

• Soft skills management training


CONTACT INFORMATION

Vladimir Krechikov, MD, PhD, MSc

Director of Business Development

Tel.: +353 151 33 525

E-mail: [email protected]


THANK YOU

cromos™ pharma general presentation

Health & Medicine