Newsletter | November 17, 2022

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 & ComplianceUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Outsourcing Models
Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases

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.

Think Your Large CRO Can’t Fail? Think Again

Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.

Phase 2/3 Outsourcing Partner Selection Attributes

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.

5 Must-Haves In A Contract Packaging Partner

A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship. 

Three Steps To A Client-Focused CRO Cloud Environment

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.

The Right-Sized Partner For Your Epilepsy Program

Learn about the CRO with over 245 full-service neuroscience trials conducted, including rare and orphan indications in over 50 countries around the world.

Regulatory & Compliance
Survey Reveals High Levels Of CTIS Adoption In Europe

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.

Optimizing Regulatory Lifecycle Management

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.

Go/No-Go Decisions Based On Early-Phase Oncology Trials

In this webinar, gain insight into the latest regulatory and clinical developments in the field of oncology in China.

How Global Regulations Impact Technology: Shared Responsibility For Maintaining Compliance
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.
Understanding The Scope And Pain Points Of Study Start-Up, Part 2: The Evolving EU Landscape

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.

Expert Medical Writing For Your Every Need

Our medical writing experts can help you tailor a complete range of regulatory documents that open doors to the future success of your project.

Oracle Safety Cloud

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.