Clinical Development

In this section you may find indication on the role and function of clinical studies in research and drug development.

  1. Showing 13 results for:
  2. Research and Drug Development
  3. Clinical Development
All Subjects

ECRIN Services

Published by n/a

ECRINMultinational clinical trial

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.

View this resource Bookmark this resource

ECRIN Services

Published by n/a

Clinical TrialData manangementECRINInsurabce supportMonitoring

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. 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

View this resource Bookmark this resource

ACT-EU is the stakeholder fora and groups within the European medicines regulatory network (EMRN) 

Published by ACT EU

Clinical TrialCTAGNetworkRegulatory

A list of stakeholder fora and groups within the European medicines regulatory network that are involved in the clinical trial lifecycle. Detailed information is published on each group or forum, along with a visual representation of their interactions.

View this resource Bookmark this resource

Patient Engagement Resource Center

Published by EATRIS

Patient EngagementPatient InformationResearch and Drug Development

The Patient Engagement Resource center is an easy to navigate platform to help researchers get started with patient engagement in research. This toolbox provides helpful resources to help researchers understand the basics of patient engagement, and guide them through the different phases of patient engagement, from planning to conducting and evaluating.

View this resource Bookmark this resource

Short guide on patient partnerships in rare disease research projects

Published by EJPRD

Patient EngagementPatient InformationResearch and Drug Development

This guide has been developed with the help of a working group comprising of patient representatives and research funders. Its main goal is to encourage fruitful, sustainable and enduring partnerships between scientists and patient organisa tions, co-leading the way for systematic patient-centered research. It also aims to foster a partnership culture and contribute to an improved understanding of the added value of patient engagement and involvement in basic, pre-clinical, translational and social research for the Rare Disease Community in Europe and beyond.

View this resource Bookmark this resource

Clinical trials – Regulation EU No 536/2014

Published by EMA

Clinical TrialRegulation

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements

View this resource Bookmark this resource