Contact - Mediserv

Transcription

Contact - Mediserv
Contact
Odette Jochems
CEO
MediServ B.V.
De Stadspoort 32
5611 GZ Eindhoven
The Netherlands
Tel. +31 (0)402433070
Fax +31 (0)402434505
[email protected]
www.mediserv.nl
Nadja Schikhof
Project Management
Elise Wiermans
Office Management
THE One-Stop Contractor in
Clinical Research
MediServ is an independent contract
organization, established in 1980 as the
first of its kind in the Netherlands.
Today MediServ covers
The Benelux and via PSN, Pharmaceutical
Service Network, all European countries,
North America and Canada.
PSN,
Pharmaceutical Service Network
Our services
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Clinical Research and Statistics
Regulatory Affairs
Training and Education.
Regulatory Affairs
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Clear Cost control
We bill either man-hours or the contract
price. The client receives a budget break
down.
Clinical studies
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Pharmaceutical drugs in Phase IIIV
Medical Devices
Design/Protocol/CRF/Monitoring
Data Management/QC/QA
Periodical Reporting
Investigator’s Brochure, IMPD
Statistical Report
Final Study Report
Preparation of
Publications/Lectures.
Registration of products in the Netherlands,
Belgium, ranging from general advice to
actual dossier applications.
Preparation of adequate texts for part IB
(Summary of Product Characteristics), The
Patient Information Leaflet and the
Package Labels according to current rules.
Training and Education
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In-house training courses
External courses on clinical drug research
National and international courses
Workshops.
MediServ offers international services in
Europe through its partnership in PSN.
PSN comprises the five CRO’s
 ARG, United States
 CCA, United Kingdom
 Dimensione Ricerca, Italy
 Klifo A/S, Denmark
 medicomp GmbH, Germany
 MediServ, The Netherlands
 RCTs, France
 Sermes, Spain
PSN was founded in 1997 and is
characterized by:
 An association of medium sized
CROs
 Coverage of all European
countries, North America and
Canada
 Well-esteemed, financially stable
and growing CRO-companies
 Co-operation with one CRO on
multinational trials
 Task performance according to one
set of common SOPs.