Accovion’s EuropeanDoorOpener provides modular service solutions designed to support your small- or medium-sized pharmaceutical, biotechnology or medical device company in all aspects of your European development program.
With Accovion’s EuropeanDoorOpener, you’ll have instant access to regional expertise and resources that will save you time and money, and add quality to your projects.
Nine different modules enable you to select one or more of the services you need to conduct clinical trials and apply for marketing approval of your product within Europe.
offers information on the regulatory environment, submission and documentation needs and other aspects specific to the region and individual countries.
- Role of the European Medicines Agency.
- EU Clinical Trials and Medical Device Directives.
- Countries, diversities and languages.
- Best practices and underlying research environment.
- Health economy.
- Country-specific dossiers with general information on required documents, regulations and planning of a compliant European clinical trial.
- “Reverse planning” tailored to your project specific needs that will help fine tune your project forecast and schedule.
This module provides services that support and ease your day-to-day business during the planning and preparation phases of your clinical trials.
You’ll receive study-specific information for:
- Consultancy for country selection.
- Legal requirements (mediated by Accovion).
- Material logistics.
- Preparation of documentation (including translations) required by independent ethics committees (IEC) and competent authorities (CA).
- Submission or consultancy for submission to ethics committees and competent authorities.
Modules 3 to 9
These additional modules provide the full range of services needed, starting with the planning phase, conduct and analysis of your clinical trials through to marketing approval of your product. Services cover all aspects from trial initiation and conduct to analysis, reporting, and submission documentation.
For more information regarding the EuropeanDoorOpener, click here for a brochure.