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| When A Rare Disease Partnership Evolves Into A Global Effort | Guest Column | By Ken Kahtava, FSHD Society, and Mel Hayes, Fulcrum Therapeutics | 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. |
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| Top Tips For Taming CRO Turnover | Article | By Cathy Gooch, senior VP, people operations and culture, Biorasi | 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. |
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| Unlocking Europe's Commercial Potential For Biopharma Startups | White Paper | By Markus Gores, Tom Woods, and Michele Cimmino, IQVIA Biotech | 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. |
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| Global Resourcing Maximizes PV Operations To Meet Timelines | Case Study | PPD FSP Pharmacovigilance Solutions | 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. |
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| 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! |
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| What Does The New FDA DHT Guidance Mean? | White Paper | ActiGraph | 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. |
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| 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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