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MULTINATIONAL STUDIES

Using MediServ will gain you access to the full range of services needed for successful clinical research & development in a multinational environment.

Background

In general in Phase II a small, carefully selected numbers of relevant subjects are treated in single centre trials to evaluate the efficacy, safety, tolerance and possibly the pharmacokinetic characteristics of the drug under investigation. During Phase III confirmatory studies, enough data from a sufficient number of relevant subjects in more realistic circumstances need to be collected within a fixed time-frame. This is usually achieved through the organisation of multicentre/multinational studies.

Multicentre trials present their own challenges, such as:

- Consistency between the centres, facilitated by investigator meetings, training and careful monitoring.

- Consistency in subject intake, which can be assured by a balanced distribution of subjects and treatment arms of over the centres.

Multinational studies

International studies are sometimes necessary for a comparison between patient populations, and/or to test the medicine or device in countries using the appropriate regulatory or marketing conditions for products. Achieving a sufficient number of subjects can also lead to the choice of a multinational study.

The aim of MediServ is to provide reliable, quick and flexible services for national and international clinical trials, not limited by company size and resources. MediServ, itself, operates in the Netherlands and Belgium for geographic reasons: Eindhoven being in the centre of the Benelux.

Further, MediServ is co-founder of PSNResearch, an international full service CRO, covering Europe and Northern America. In 1997, Michael Gierend and Odette Jochems brought together large scale international project management and regional clinical expertise to address an underserved group of Sponsors. In doing so, they created PSNResearch a team custom-fit piece by piece to outperform mega-CROs; building relationships in dozens of countries and localities worldwide. PSNResearch is dedicated to delivering clinical development success to agile and emerging biopharma firms.

PSNResearch believes that providing customized, personal service is what sets them apart from other clinical research organizations. Sponsors have found that PSNResearch is devoted to building relationships with all stakeholders in the complex process of clinical development.

PSNResearch's unrivaled local expertise on regulatory authority strategies, ethics review processes and relations with specialized investigators enable us to provide proven competitive timelines and exceed your expectations.

 


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