proprietary and confidential GENERAL PRESENTATION where the patients are
proprietary and confidential
GENERAL PRESENTATION
where the patients are
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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)
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GEOGRAPHICAL COVERAGE
Coverage (offices or home-based)
Office, Clinical Operations
Office, Finance
Moscow
Smolensk
Tbilisi
Dublin
Kyiv Prague
Budapest
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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
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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
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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
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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
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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
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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
proprietary and confidential
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
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RECENT EXPERIENCE by therapeutic areas
N = 91, as of 21 March 2017
(only projects involving monitoring)
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RECENT EXPERIENCE Post Marketing Studies (phase IV and
observational)
N = 18, as of 21 March 2017
(only projects involving monitoring)
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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
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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%
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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
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CONTACT INFORMATION
Vladimir Krechikov, MD, PhD, MSc
Director of Business Development
Tel.: +353 151 33 525
E-mail: [email protected]
proprietary and confidential
THANK YOU