Supporting your Innovation

CONTENT

• Mission

• The European Market

• Regulation in the EU

• Product Lifecycle

• Price and Reimbursement

• Our Services

• Company Profile

• Full Services Provided

• Company Organization

• Team of Experts

MISSION

“Be the best at what you do”

Our aim is to help you promote your innovation in Europe’s growing

market.

At ClinSearch we work to ensure that our team of highly qualified

healthcare specialists delivers the best quality results and a high level

of availability to meet and exceed the needs of our clients.

With this in mind, Clinsearch provides outstanding solutions that are

not only adapted but complete.

“Promoting and supporting your innovations through quality

research and trials “

“Bringing your innovations the recognition they deserve “

MANAGING DIRECTION AND RESEARCH DIVISION

Directors

Fabrice RUIZ

14 years of experience in biomedical research and epidemiology. Vice-President of a Master’s Engineering SchoolMasters in Biotechnology

Jérôme SEYMOUR

20 years of experience in biomedical research and epidemiology. 8 years in Medical Device.Field work for an American CRO (OMNICARE) in order to create the French entity (5 years as Deputy General Manager)PhD in Immunology

MANAGING DIRECTION AND RESEARCH DIVISIONSenior Consultants

Sandy MAUMUS-ROBERTProject Manager – Medical writer 5 years in Public Health, epidemiological and data mining at public (INSERM, INRIA) and private (ClinSearch) organizations.PharmD – PhD in Epidemiology and Public Health

Abir TalmoudiScientific and medical Advisor – Medical writer 8 years of experience in fundamental, biomedical research PhD of sciences in « Biotechnology, Health and Management »

MANAGING DIRECTION AND RESEARCH DIVISIONSenior Consultants

Evelyn BoosMedical Advisor Evelyne is a doctor of medicine. She has a University degree in clinical oncology. She worked at

the French Sentinelles network on the estimation of the expected impact resulting from a strategy of vaccination in adults after exposure to the varicella zoster virus in France. She joined ClinSearch in 2013

MD

Cécile TrainProject Director Cécile has been working for ClinSearch since 2001. She has extensive experience working in

clinical research gained through monitoring activities as well as regulatory submissions. Cécile's expertise in project management was honed during several years spent working for internal projects and a two-year outsourcing mission for one of the world leading pharmaceutical companies.

MSc in Engineering

SOLUTION

ClinSearch can define a strategy, draft a development plan and build the

tools that will have an impact on authorities

ClinSearch has the methodology, the clinical experience, and the

qualified experts to bring your innovation forward.

The right Method, the right People, at the Right Price

Make a difference

Reach Authorities

The right Clinical Experts

The right innovation

REGULATION, PRICING, AND REIMBURSEMENT

Manufacturers MUST focus on country-specific reimbursement

ClinSearch has the ability to assist you in any EU market

Data gathered for CE Mark DOES NOT guarantee reimbursement

Evidence is needed for:• Clinical efficiency

• Cost effectiveness

• Added value compared to competitor products

ClinSearch gathers the best evidence for you, adapted to your device, and to the chosen EU market

Need to know WHAT evidence is required for the specific reimbursement

ClinSearch knows how to select the evidences required by authorities

Don’t wait until the CE mark to collect evidence required for pricing and reimbursement.

PRICING AND REIMBURSEMENT

OUR SERVICES - EUROPEAN MARKET

How can ClinSearch assist you?

1. By identifying country-specific reimbursement requirements- Consulting and Advisory Services

2. By gathering the necessary evidence adapted for your device

and for the chosen market- Analyzing clinical data

3. By delivering quality evaluation

- Identifying pertinent clinical data sourced from literature

- Using clinical experience and/or clinical investigation

- Appraisal of individual data sets

- Analyzing relevant data

4. By helping you obtain recognition and reimbursement

- Advising, Medical writing of reports, publications, etc.

FULL SERVICES PROVIDED

ClinSearch has multiple competences but we are active uniquely in ourfield of expertise.

After 12 years of providing excpetional services in the life science industry, including 6 years in medical device, we are looking to promote new innovations in Europe through the support of quality evidence.

Our offer...

• We work towards the emergence of innovative projects• We carry out critical analysis of your projects • We guarantee complete information security and deadline respect• We provide unlimited access to our procedures • We apply Quality Control procedures every step of your project

Business Sectors

Expertise

• Methodological conception

• Regulatory affairs

• Assistance in study design and

development for the French health agencies

(Commission of Transparency, Price

Commission, etc..)

• Assistance in the creation of healthcare

networks and evaluations

• Elaboration of risk management plans

Data Analysis & Reporting

• Biostatistics & Data management

• Medical writing

• EMEA-CTD, Commission of

Transparency dossiers.

Operations

• Epidemiology

• Health Economics

• Clinical Research

• Public Health

Information Systems

• Patient Registries – Data management

• Safety surveillance and reporting

• Project management tools

COMPANY PROFILE

Methodological Solutions• Cross-sectional Studies• Case-control• Cohort Studies• Registries• Randomized Controlled Trials