The information and resources in this section can help you navigate in the Research and Drug Development area to identify issues classified for:
Disease models,
Disease/Translational resources,
Drug Discovery,
Clinical Development,
Published by EBStatMax team
Clinical Trial DesignResearch and Drug DevelopmentThis document provides a project overview and a summary. It can be used as the body of the innovation management toolbox website
Bookmark this resourcePublished by Konstantin Emil Thiel (EBStatMax)
Clinical Trial DesignResearch and Drug DevelopmentSource code of the Rare Disease Analyser, the webapp that implements statistical methods for rare diseases
View this resource Bookmark this resourcePublished by EBStatMax team
Clinical Trial DesignResearch and Drug Developmentdetailed instructions on how to use the RDA
Bookmark this resourceERN Skin webinar on the EBStatMax project outcomes given by Prof. Johan Bauer and Dr. Georg Zimmermann on 30/01/2024
Bookmark this resourcePublished by EU-STANDS4PM consortium
ethicalIn silicoLegalThis report therefore surveys the legal landscape for health data integration, and the challenges which arise when information is re-used to develop analytical or predictive model, which are then re-applied to a patient population
View this resource Bookmark this resourcePublished by European Medicines Agency (EMA)
Drug DevelopmentEMAGuidelinePharmaceuticalsThis guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D.
View this resource Bookmark this resourceThis site provides a central resource for the European fly community. It contains useful information about the European Drosophila Board, which supports community initiatives and oversees the organisation of the biennial European Drosophila Research Conference.
View this resource Bookmark this resourceWhen 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.
View this resource Bookmark this resourceECRIN’s Data Centre Certification programme is ISO 9001:2015 certified and was developed to audit European, non-commercial data centres using ECRIN IT/DM standards, to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials
View this resource Bookmark this resourceDuring 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. ECRIN 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
