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 Clinical Research and Statistics Regulatory Affairs Training and Education. Regulatory Affairs Clear Cost control We bill either man-hours or the contract price. The client receives a budget break down. Clinical studies 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 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.