Newsletter | December 7, 2023

12.07.23 -- Improving Accessibility For Patients With Disabilities

SPONSOR

In the modern globalized landscape, drug developers are increasingly adopting follow-the-sun (FTS) business models to cater to customers worldwide. By partnering with a reputable functional service partnership (FSP) provider, biopharmaceutical innovators can leverage their extensive global expertise and capabilities to effectively implement an FTS model. This white paper examines the essential factors and benefits that sponsors should consider when pursuing an FTS model through an FSP partnership.

REGULATORY & COMPLIANCE

Improving Clinical Trials Accessibility For Patients With Disabilities

While increasing DE&I in clinical trials is essential to all individuals, this article speaks to considerations for removing barriers and improving trial accessibility for individuals with disabilities. Discussion includes combating stigma and bias, changing structural design, and more.

The FDA Race And Ethnicity Diversity Plan

Observe how the DEPICT Act not only underscores the importance of diversity in research but also sets the stage for a more inclusive and comprehensive approach to healthcare development.

Empowering Freenome: Large-Scale Data Quality And Compliance

Delve into the five key ways this biotech company was able to successfully deliver data quality and compliance for large-scale trials while developing next-generation blood tests for early cancer detection.

Regulatory And Commercial Tips For Maximizing Digital Health

Consider how these opportunities could leverage regulatory pathways and factors that could ultimately determine the commercial success or failure of digital products currently in development.

End-To-End Safety Solutions Designed For Success

As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.

SPONSOR

Webinar: Practical Applications Of ICH E6(R3) — What Do We Need To DO?

Join industry experts December 14th as they discuss the strategic, conceptual, and operational implications of the shift toward risk-based monitoring in the ICH E6(R3) draft guidelines and what sponsors and vendor partners should already be doing to thrive in the future of clinical trial management. Click here to learn more.

OUTSOURCING MODELS

Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy

If you're a precommercial biopharma looking ahead to commercial stage, evaluating partnerships is faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

Evaluating A CRO For Rare Disease Studies: A Checklist For Success

When launching an RFP, refer to this checklist to ensure comprehensive coverage of all aspects when evaluating potential research partners for the rare disease study.

The Gig Economy And GxP Auditing In 2024

Explore how this unique GxP auditing approach ensures that vendors stay compliant with all rules and regulations quickly and efficiently, benefiting sponsors and auditors alike.

How CROs Can Simplify Billing

Get help streamlining workflows, reducing errors, improving visibility, and enhancing your customer’s billing experience by embracing a robust, modern industry-specific ERP solution.

Employing An FSP Partnerships Model In Non-Footprint Countries

Maintaining a robust global presence has become a pressing demand. Review this collection of strategic avenues when navigating the clinical trial landscape to promote successful research initiatives.

Solutions For Successful Clinical Research Staffing

Whether a short- or long-term engagement, see how Advarra Consulting Institutional Center of Excellence's specialized research professionals can help you reach your goals for lasting success.

Imagine… Easier, Proactive Drug Development

Imagine partnering with a single CRO/CDMO for your early-phase drug development. With Altasciences, you don’t have to imagine — learn how they’re able to deliver for your project.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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