Newsletter | February 1, 2024

02.01.24 -- When A Rare Disease Partnership Evolves Into A Global Effort

OUTSOURCING MODELS

When A Rare Disease Partnership Evolves Into A Global Effort

Marked by a gradual evolution from small, meeting-oriented work to a transformative initiative, the FSHD Society and Fulcrum Therapeutics partnership in rare disease research exemplifies the power of trust and shared commitment.

Top Tips For Taming CRO Turnover

Employee turnover, even during complex clinical trials, should never be the breaking point of a project. Avoid these instances and keep studies on track by developing proactive employee retention strategies.

Unlocking Europe's Commercial Potential For Biopharma Startups

While the U.S. market remains the primary focus for most EBPs, they need to broaden their horizons to maximize product value. Dive into this compelling case for launching in Europe and how to succeed.

Global Resourcing Maximizes PV Operations To Meet Timelines

Discover how clients were able to leverage the extensive resources of PPD FSP Pharmacovigilance globally, maximizing their PV operational delivery model and successfully meeting ambitious timelines.

SPONSOR

2024 PDA CDMO Partnership Workshop

Unlock success in the pharmaceutical and biotech industry by attending the 2024 PDA CDMO Relationship Management Workshop, March 28-29, in Long Beach, CA. Gain invaluable insights into optimizing critical partnerships with CDMOs. Learn how to streamline communication, enhance project oversight, navigate regulatory complexities, and control costs effectively. Discover best practices for supplier selection and risk mitigation. Learn more and register today!

REGULATORY & COMPLIANCE

Knowing When To Take Action In A Regulatory Submission Crisis

While a few red flags are common during any regulatory submission, several occurring in concert can precipitate a crisis. Learn who you can turn to for help and when it's time to seek assistance.

What Does The New FDA DHT Guidance Mean?

In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.

Orphan Drug Designation: Considerations, Rewards, And Differences

The National Institutes of Health (NIH) estimates that one in 10 Americans are affected by a rare disease or condition. Explore global challenges and regulatory frameworks for rare diseases in this presentation.

Clinical And Regulatory Strategy For Biotechnology Companies

Get support from clinical regulatory specialists with expertise in creating clinical and drug development plans, GMP compliance, designing and coordinating GLP-compliant toxicology studies, and more.

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