Support for Trial Management Across Borders
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.
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 (learn more about Data Centre Certification)
- 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.
Ensuring Quality Management
An 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. 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.