Let clinical evidence support innovation

Who we are

What we can do for you

Why you should go outside US for your innovation

developmentTo Europe…

…or further: Middle East

• A European Contract Research Organization specialized in Clinical Evaluation

• Founded in 1999

• An international team of highly qualified experts

• With a high level of availability to our customers

• We own a well defined Quality System based on international quality standards

• We are committed to operating in a compliant and ethical manner in your interests

• EU accounts for ¼ of the global medical device market.

• EU’s regulatory system is open and transparent, and based on international standards.

- CE marked products can reach patients 2 to 3 years earlier than in the US.

- 5 to 10 times less capital than in the US to achieve regulatory approval.

• Furthermore, in the last decade, Eastern European countries, among others Croatia, Bosnia,

and Serbia, gained extreme importance for clinical research:- High patient enrolment potential

- Highly experienced and motivated KOL, with working experience in US and/or Western

European countries.

- Adaptation of their national regulations according to EU directives and strict application of

GCPs.

We provide consultancy and operational services for Medical Device.

Our solutions are not only adapted but complete OUR SERVICES:

Safety and risk management

Statistical and methodological consulting

Clinical data management

Statistical analysis and reporting

Medical writing

Project management

Clinical monitoring

Audits

Post-marketing surveys

Price and reimbursement dossiers

We help you promote your device in Europe’s

growing market and obtain a fair reimbursement by

performing any necessary clinical evaluation or

investigation:

• Guidance on clinical evaluation strategy

• Bibliographic review and meta-analysis

• Analysis, reporting and publishing of existing data

• Controlled clinical trials

• Observational studies: cohorts and registries

• Diagnostic accuracy studies

• Medico-economic evaluations

The Middle Eastern market for medical devices is expected to increase around 41% by 2014.Middle East, in particular United Arab Emirates, Kingdom of Saudi Arabia, Qatar and Bahrain, is becoming

a more attractive market for clinical research because of the rising costs of clinical trials in the West and

the need for a greater market.

The growing scientific and medical community coupled with good international collaborations is promoting

medical research in the region.

ClinSearch – Paris: +33 1 47 35 17 17

Contact: Allison Brown (Mob) +33 6 99 60 40 52 — allison.brown@clinsearch.net

Go outside US, but above all, invest in the strongest and earliest

clinical evaluation to guarantee success

Why you should work with ClinSearch

Recent amendments made to the Medical Device Directive (MDD 93/42/EEC) state that every

medical device sold in Europe, regardless of its classification, must have a clinical evaluation report in

its technical file.

Concurrently, national health authorities, facing rising health costs, are stricter about reimbursement

issues leading to greater demand in clinical evidence for performance, safety, and efficacy.

Don’t view it as a a burden but as an opportunity

- to make your innovative product stand out from the rest

- to save time

- to save money

- to make profits: obtain rewarding reimbursement rates

- to ally market growth and compliance: the best way to collaborate

with healthcare professionals.

We want to promote your innovation, not hide it!

The innovative product you develop deserves the best strategy to access markets outside US. ClinSearch has

the ability to assist you on any EU, Western Europe or Middle East market throughout your product lifecycle,

thanks to a team fully fluent in the various languages spoken in these countries (e.g. Arabic, Polish or Slavonic).

Let’s prove your innovation with evidence-based medicine

Let’s work together in the patient’s best interest Clin

Se

arc

h P

ari

s: +

33

1 4

7 3

5 1

7 1

7

Em

ail:

info

@clin

se

arc

h.n

et —

We

bsite

: h

ttp

://w

ww

.clin

se

arc

h.n

et

Avoid the pitfalls of clinical

evaluation thanks to our

expertise in Medicine,

Methodology and Statistics,

and Medical Writing.

Manufacturing

and Release

Marketing

authorization

Price and

Reimbursement

Market access

Device

improvements

Medical device

Design

Clinical evaluation

Real-life studies

Health-economic studies

Clinical evaluation

Evidence-based Medicine

CE marking (Notified Body)

Based on both the innovation of

your device and the quality of

collected clinical data we

guarantee you a strong dossier

for a fair reimbursement.

Clinical evaluation

Clinical evaluation

Clinical Investigation

Preclinical

studiesClinical evaluation

Feasibility studies