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| Gone are the days of paper, illegible handwriting, and data quality nightmares. eCOA and ePRO are revolutionizing the way clinical trials generate data. Register today for the next Clinical Leader Solutions Expo for a comprehensive understanding of the available options from leading suppliers. A can’t-miss opportunity to conveniently find the trial data capture solution that aligns perfectly with your study objectives! |
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| Navigating China's Biologics Approval And Accelerated Pathways | Guest Column | By April Wang, Accestra Consulting Company | Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them. |
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| Bridging The Gap: Breaking APAC Into The U.S. FDA Market | Article | By Jonathan Helfgott, MS, Healthcare Innovation Catalysts, Former Associate Director for Risk Science, US FDA, CDER and Mathew Thomas, MBBS, Ph.D., Healthcare Innovation Catalysts, Former Director of US FDA India Office, Senior Policy Advisor US FDA, CDER., Biorasi | For APAC companies, it's important to identify the differences in care standards, formulate strategies for compliance, and develop solutions to bridge the regulatory gap and realize FDA approval. |
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| IQVIA Labeling Compliance Solutions | E-Book | By Ankit Tyagi, Rama Mohan Rao Chikkam, and Donald Palmer, IQVIA Safety & Regulatory Compliance | Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company. |
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| Modernizing TMF Culture To Better Support Today's Clinical Trials | TMF can represent two very different concepts: for some, it's "Trial Master File," while for others, it jokingly stands for "Too Much Fun!" This duality highlights diverse attitudes toward the essential task of preparing and managing the content within the TMF. When structured as a more engaging and less overwhelming task, the TMF can be more beneficial for all who must collaborate to complete it. |
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| Biopharma In Nonfootprint Countries Gets Support | Case Study | PPD FSP Solutions | Uncover how this tailored solution helped a multinational pharmaceutical and biotechnology firm to develop an in-country presence and expertise, which was critical to meeting their study timelines. |
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| Altasciences’ Facilities Moving In Unison | E-Book | Altasciences | With nine facilities across North America, explore our integrated, comprehensive solution for all your early-phase drug development needs and unique expertise. |
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CHOOSE YOUR OWN ADVENTURE |
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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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