Give Your Input on Impact of EU Clinical Trials Directive
ICREL allows you the opportunity to give your input through a survey about the EU Clinical Trials Directive.
Brussels, Belgium-June 9, 2008-ICREL is a one-year EU FP7 project, coordinated by EFGCP with further consortium members being EORTC under leadership of Denis Lacombe, ECRIN under leadership of Jacques Demotes, The Ethics Committee of the University of Vienna under leadership of Christiane Druml, and Hospital Clinic I de Barcelona under leadership of Xavier Carné. The project aims at analyzing the impact of the Clinical Trials Directive 2001/20/EC on clinical research in Europe.
ICREL has just launched a survey, giving sampled-out stakeholders (commercial and non-commercial sponsors, ethics committees, and competent authorities) the opportunity to have their experiences taken into account. As the results of this survey will form the basis for the European Commission Directorate Entreprise for their decisions on areas to be changed in the new clinical trials legislation it is very important that we collect as much information as possible. WE NEED YOUR SUPPORT!!!!
Please go to www.eortc.be/icrel and complete the questionnaire suitable for your type of organization.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
