Supporting clinical trials across borders
The services provided by ECRIN staff in relation to preparation, set-up, and management of multinational clinical trials in all medical domains for academics and SMEs are ISO 9001:2015 certified. The image below outines the different ways in which ECRIN can support you.
Discover the information on the Access and Cost of the Services.
Ensuring Quality Management
ECRIN develops and implements an effective QMS that offers a clearly structured, systematic approach to improving research and maintaining the highest quality standards.
For ECRIN’s internal processes, quality is assured through Standard Operating Procedures (SOPs), guidelines and training. For national scientific partners (i.e., clinical research infrastructure networks), quality is achieved through compliance with ECRIN quality standards. These standards (e.g., requirements for data centre certification) are used to confirm partners’ capacity to provide appropriate and effective services.
Additional Activities to Support Multinational Clinical Research
ECRIN is also involved in activities to enhance the ability of European institutions to successfully conduct multi-country clinical research. This can include, for example, the creation and maintenance of tools or databases, or the recognition/certification of high-quality data centres.
Moreover, ECRIN is involved in infrastructure development projects that aim to further develop the European clinical research community and to facilitate multinational trials. For more information on the project or the full list of projects visit the dedicated pages.
Discover the infrastructure development projects.
When planning a multinational clinical trial, you need to consider financial, scientific, regulatory and administrative aspects long before you recruit the first patient. It is necessary to access experts and patients at other sites and countries, but complying with local regulations and requirements, sourcing services, and identifying collaborators can be a challenge. ECRIN is here to guide investigators/sponsors, project coordinators and other stakeholders through the different facets of multinational trial organisation.
Before the start of the trial, ECRIN offers advice on:
- Funding: ECRIN advises on possible sources of funding as well as aspects of the structure of your funding application such as work package architecture, impact, management, governance, consortium composition, and multinational clinical trial management
- Site mapping and participant recruitment: ECRIN's in-country European correspondents can provide details of investigator sites and networks in their countries that can recruit participants for your study
- Selection of clinical trial units: European correspondents can provide input on the facilities in their country that have the capacity and services needed for your trial
- Regulatory and ethical requirements: ECRIN guides you through the necessary steps to meet different requirements in each country
- Insurance requirements: ECRIN provides information regarding the necessary insurance for multinational clinical trials in different countries
- Costs: Costs of ECRIN trial management services are calculated by ECRIN to help you prepare your budget
In the phase immediately preceding trial implementation, ECRIN can provide the following services:
- Scientific & methodological evaluation: When the time comes to write or revise the full protocol, ECRIN supports you by providing methodological consulting and independent input on the scientific and methodological features of the protocol. This evaluation is done by ECRIN’s Scientific Board of clinical research experts.
- Logistical assessment: As well as the science, logistics must be considered so that your trial runs smoothly. European correspondents assess the practicality of plans in each country and give suggestions and alternative plans where necessary.
Scientific/methodological and logistical assessment are requirements for projects to access ECRIN trial management services.
ECRIN provides ISO 9001:2015 certified trial management across borders and, through local ECRIN European Correspondents with the contribution of their national partners, helps to overcome obstacles that occur due to working in different country systems. The effective Quality Management System (QMS) is a key component of trial management and ensures the protection of trial participants and the reliability of study results.
During project implementation, ECRIN offers investigators and project coordinators various trial management services, accompanying them all the way from recruitment of the first patient to scientific publication. Our services include:
- Submissions to competent authorities & ethics committees: ECRIN can manage submissions to regulatory and ethics authorities in participating countries, ensuring that timelines are respected to avoid delays
- Insurance support: ECRIN can provide information regarding multinational trial insurance OR ECRIN can provide quotations for local insurance for multinational clinical trials
- Monitoring: All tasks related to monitoring such as training, on-site visits and reporting can be handled by ECRIN across country sites
- Adverse event reporting: ECRIN can support local reporting according to national requirements
- Data management: ECRIN-Certified Data Centres may be used for data management in multinational trials
- Recommendations for health product and biosample management: ECRIN can provide contacts for medicine and sample handling across countries
How to Access Trial Management Support
ECRIN trial management services are provided at not-for-profit rates to projects approved after a scientific evaluation by the ECRIN Scientific Board and a logistical assessment by the ECRIN European Correspondents. The approval procedure takes seven weeks from protocol submission.
ECRIN Members and Observers can benefit from the full range of ECRIN clinical operation services for multinational trial preparation, protocol review based on clear assessment criteria, and/or operational trial management.
Advice and information are provided free of charge by the ECRIN core team and European correspondents (EuCos) to academic clinical trial projects involving at least two ECRIN Member and Observer countries.
Trial management services are provided at not-for-profit rates to academic sponsors. These rates reflect the non-profit cost of the services carried out by the national scientific partner (in ECRIN countries).
To be eligible for ECRIN support, projects must involve at least two Member or Observer countries. The projects must be reviewed and approved by the ECRIN Collaboration Committee. To find out more on conditions of access and/or submit your project, contact your European correspondent and consult the ECRIN policy “Access to ECRIN Clinical Project Services” and the ECRIN Scientific Board eligibility criteria for access to clinical project services.
ECRIN can provide support services even if the trial’s coordinating country is not a Member or Observer, if at least two ECRIN countries are included in the project. However, in this case support during the period of grant proposal preparation and study design development are not provided.
To find out more about conditions for access and/or submit your project, contact your European correspondent and consult the ECRIN Scientific Board eligibility criteria for access to clinical project services.
Discover the ECRIN Scientific Board and its members.
Who to Contact
The first point of contact for ECRIN trial support services is your local European correspondent. If there is no European correspondent for your country, contact the ECRIN core team.
Additional Information on Cost Policy
ECRIN also offers services to industry sponsors at market rates. These activities do not account for more than 20% of the ECRIN portfolio, as described in its Statutes. In such cases, a separate accounting system is used without VAT exemption.