Partnering withClinSearch

2015

Ivelina Georgieva, International Account Manager

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ClinSearch in Brief

• Founded in 1999 by Jerome Seymour, PhD, and Fabrice Ruiz, MS

• Headquarters: Paris

• Current staff count: 60, including medical and scientific advisors, project

managers, monitors, statisticians, data managers, IT specialists, and medical writers

• Annual turnover: 4 million EUR

• Clients include big pharmas and medical device manufacturers, biotechs and public health institutions.

ClinSearch in brief 2015

3ClinSearch & You 2015

• Faster return on investment

• Increased capital gain

• Increased stability

• Heightened confidence in

products

• Gain a committed consultant

YOU

• Accelerated clinical process

• Faster and more efficient path to market

• Successful regulatory submissions

• Receiving reimbursement

• Limit resourceexpenditure

YOUR INVESTMENT

• Expert knowledge

• Develops and implements an effective

clinical strategy

• Proactiveness and entrepreneurship

• Performs all clinical processes in-house with

stringent QA

• Access to international investigation sites, close long-term partnerships

CLINSEARCH

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OUR SERVICE LINES :

Scientific consulting

Projects include: clinical evaluation; study design and statistical methodology, review and editing of client synopses, scientific communication, KOL communication, supporting abstracts, publications, papers; pricing and reimbursement for France and for other countries.

Our people:

ClinSearch Experience 2015

ABIR TADMOURI: PhD in biomedical

engineering, PG diploma in biostatistics, PG

diploma in clinical research, currently studying

PG in Health Economics. 7 years of experience in

basic neuroscience research; joined ClinSearch

in 2010.

EVELYNE BOOS: MD with a degree in clinical

oncology, partially completed at Duke.

Experience with the French Sentinelles

network working on the estimation of impact of

vaccination of adults after

exposure to the varicella zoster virus in

France; with ClinSearch since 2013.

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OUR SERVICE LINES:

Monitoring and Project Management

• Extensive experience with clinical and non-interventional studies (post-marketing surveys, cohorts, and registries)

• Ad-hoc, flexible monitoring schemes, ideally suited to a SME

• Multilingual CRA team, easily deployed to any location in Europe and MENA, utilizing the low-budget flights available from Paris

• Centralized project management model, enabling harmonization of all operations and superior quality assurance

• Prowess in regulatory dealings with Europe and MENA.

ClinSearch Experience 2015

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OUR SERVICE LINES:

EDC development, MedDRA coding

ADVANTAGES:

Customization of electronic case report forms (eCRFs)

Web-based platform , providing access for si tes to enter data

Cleaning and locking process on-the-go, in which any queries against the data are resolved at entry

Adaptation of the f inal data to SAS datasets

Cost advantage .

ClinSearch Experience 2015

INCLUDES:

Developing data val idation plan

User training and management

Visual implementation of si te data

Creating alerts

Data cleaning and locking on the go

Data reports

Data safety and repository function

Integrated MedDRA coding.

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OUR SERVICE LINES:

Medical Writing & Statistics

Medical Writing Projects include: • writing all study documents (CRF, PL, ICF, study report); • articles & publication materials, posters & slide kits;• scientific committee management; • translations;• conference attendance and minutes taking.

Statistical Projects include: • statistical study design (sample size calculations, statistical power,

randomization);• statistical analyses plans (SAPs);• statistical reports;• SAS programming.

ClinSearch Experience 2015

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OUR SERVICE LINES:

Site Management/ MDKeys network

MDKeys: a partnership between ClinSearch and more than 70 physicians in 11 hospitals in Eastern Europe and Scandinavia

The role of ClinSearch:•Directly manages the sites, hospital contracts and physician agreements;•Sets procedures specific to MDKEYS;•Deploys specialized CRA speaking local languages;•Ensures quality of collected data.

ClinSearch Experience 2015

ADVANTAGES:

• Epidemiological context;

• High potential for patient recruitment

(centralized healthcare);

• Center audits;

• Clinical Research training;

• Compliance with international laws,

regulations, standards and SOPs;

• Physicians and hospital agreements

in place/ quick start of projects.

9ClinSearch Experience 2015

Anesthesiologists

Cardiac Surgeons

Cardiologists

General Surgeons

Gastroenterologists

Gynecologists/Obstetricians

Interventional Cardiologists

Interventional Radiologists

Neurologists

Oncologists

Orthopedic Surgeons

Spinal Surgeons

Physicians and KOL’s

Countries

Austria

Belgium

France

Germany

Italy

Middle East

(several countries)

Netherlands

Spain

United Kingdom

Bosnia &

Herzegovina

Bulgaria

Croatia

Macedonia

Serbia

Norway

Our Advantages

Highly educated multilingual staff, extensive experience with medical devices, pharmaceutical and biological products

Wide in-house resource base providing seamless service (EDC, medical writing and statistics departments)

Focus on adding value and scientific accuracy, proactive partnering

Medium size, guaranteeing maximum focus on your projects

Competitive and transparent budgeting, including fixed rates per service

Split of risks (malus/bonus).

Our Advantages 201510

Compliance and Certifications

OUR STANDARDS ARE BASED ON• Legal and regulatory requirements by country• ICH — Good Clinical Practice• GHTF and AHWP guidance• Good Epidemiological Practice• Declaration of Helsinki• ISO 9001:2008• ISO 19011:2002• ISO 14155:2011• ISO 13485:2003• ISO 14971:2007

Quality Control department.

Compliance 201511

Contacts

For France:Stephanie Dousa-Callier, Business Development ManagerPhone: +33 1 47 35 13 57 Mob: +33 6 64 46 31 28stephanie.dousa@clinsearch.net

International:Ivelina Georgieva, International Key Account ManagerMob: +420 702 133 727ivelina.georgieva@clinsearch.net

Contacts 201512