The regulatory framework for performing clinical trials in Europe is complex and varies from country to country. EastHORN Clinical Services in Europe can provide you with all the local regulatory expertise to ensure the smoothest possible start to your study in the Europe.
EastHORN organizes specialized “start up” teams directly after a project is awarded. These teams consist of a regulatory expert, site contracting expert, project manager and project assistant, all dedicated just to getting the study up and running efficiently.
As more countries in Europe move towards adopting the European Union’s Clinical Trials Directive, you can be assured that EastHORN will keep up with development in each country and regulatory bodies as the situation continues to evolve. EastHORN prides itself on being able to achieve site activation faster than average for the industry in any given country.
Regulatory and Start–up services include:
- Translation of all study-related documents into local languages;
- Submissions to regulatory bodies;
- Site selection and qualification;
- Organisation of study supply logistics, including obtaining import and export licenses
- Organising local insurance coverage;
- Site and investigator contracts;
- Event management;
- Organization of legal representation;
EastHORN can provide these regulatory and start-up services as “standalone” services if required.
Contact firstname.lastname@example.org for more information on our range of services.