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| Mastering The Monitoring Visit: Key Tips For Site Success | Guest Column | By Rachana Kanvinde, MS, SFC, CCRP | The ACRP Atlanta Chapter recently hosted a Lunch-n-Learn session on “Mastering the Monitoring Visit: Key Tips for Site Success.” The conversation highlighted the shared goal of CRAs and CRCs: ensuring compliance, protecting data integrity, and making monitoring visits a collaborative — not adversarial — experience. |
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| Monitoring Application: A Flexible Technical Solution | Datasheet | PPD Clinical Research Business of Thermo Fisher Scientific | This dynamic, system-agnostic approach to modernizing clinical trial monitoring supports targeted oversight, as well as sampling at the subject, visit, and form levels. |
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CLINICAL DATA MANAGEMENT & ANALYTICS |
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| FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials | From The Editor | By Dan Schell, chief editor, Clinical Leader | As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones. |
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| How AI-Enhanced CAPA Systems Actually Work | Article | Ideagen | Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies. |
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| Clinical Analytics Use Cases For AI | Video | Revvity Signals Software, Inc. | Automating FDA data validation rules and analyzing audit trail data can significantly reduce fraud and predict areas of concern. Discover how these advancements can transform your clinical trials. |
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| Drug Development Strategy And Analytics | Brochure | IQVIA Biotech | Read how IQVIA Biotech can help develop a strategy that will effectively translate into trial execution and avoid costly amendments down the road. |
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CHOOSE YOUR OWN ADVENTURE |
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| You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. 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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