11.17.22 -- Inside Janssen's Collaboration With Academia On Immune-Mediated Disease
Welcome to the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. Update your topic preferences to receive additional Clinical Leader newsletters on:
Guest Column | By George Vratsanos, M.D., and Luke Devey, M.D., Ph.D., Janssen Immunology
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.
In the beginning of 2022, ISR surveyed 132 sponsors worldwide who outsource Phase 2/3 studies and asked them to identify attributes that are important to them when selecting an outsourcing partner. The research revealed that respondents valued operational excellence and therapeutic expertise highly when choosing a provider for their Phase 2/3 studies.
Article | By Yves Massicotte, Ropack Pharma Solutions
A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship.
Consistently providing excellent client experiences is one of the hallmarks that separate the most innovative and value-focused contract research organizations (CRO) from the rest of the field. Delve into portal proliferation and explore what a CRO-optimized cloud might look like.
Learn about the CRO with over 245 full-service neuroscience trials conducted, including rare and orphan indications in over 50 countries around the world.
Guest Column | By Kieran O’Donnell and Nicola Kidman, Arriello
Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life sciences leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.
White Paper | By Christina Bodurow, Ph.D., IQVIA Integrated Global Compliance
If a medicine’s sponsor wants to maximize the impact of the product on patients, providers, and their own bottom line, the need to proactively make regulatory affairs part of the lifecycle planning strategy is critical to the planning process.
When searching for clinical trial software, every site, sponsor, and CRO has the same question: “How does this software comply with (insert clinical trial regulation here)?” Learn the answers in this article.
In this webinar, review some key changes to the European Union regulatory framework, in particular the EU Clinical Trial Regulation (EUCTR) that came live earlier this year, and how this affects study start-up.
Oracle Safety Cloud offers the industry’s broadest platform of integrated systems and workflows to drive greater compliance and data insight while automating processes. See how you can detect risks earlier, automate processes, and increase compliance with unified multivigilance.
This newsletter is being sent to {{lead.Email Address}}. If the topics covered in it are no longer of interest to you, you can change your topic preferences on your profile page. To cancel your subscription to all Clinical Leader newsletters, please unsubscribe.
This website uses cookies to ensure you get the best experience on our website. Learn more