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| Challenging the Norm: Smaller Partners, Bigger Impact (Big is Bad Trigger) | In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair Contract Research Organization is quite daunting. Discover how a smaller full-service partner may be better suited to see your study through. |
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| Why Perfect Clinical Trial Data Is A Dangerous Myth | From The Editor | By Dan Schell, chief editor, Clinical Leader | Former FDA inspector Kara Harrison reveals clinical trials fail due to overcomplex designs, checklist-driven monitoring that misses critical issues, and lack of focus on what actually matters for patient safety and data integrity. |
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| The Regulatory Binder Checklist For Clinical Trial Sites | Article | By Meghan Hosely, Advarra | By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management. |
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| A New Approach To Generating Clinical Evidence | Article | By Janet Woodcock, Center for Drug Evaluation and Research, US FDA, DIA | For rare diseases, scientific breakthroughs often stall before reaching patients. A new approach to generating clinical evidence could change that trajectory. |
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| Regulatory Special Designations | Brochure | Halloran Consulting | Discover how securing an FDA special designation can accelerate your drug development process and bring life-saving therapies to market faster. |
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| How To Avoid Costly Study Delays And Mitigate Risks | Brochure | Palleos | Are you still in doubt about your study protocol or how to determine the sample size? Gain access to free clinical trial budgeting and MedSci consulting services from a leading Eastern European CRO. |
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| Clinical Trial Services | Video | Ropack Pharma Solutions | Explore the latest trends in sustainable living and guarantee the proper handling of your clinical materials to cover everything from warehousing and distribution to returns, collection, and destruction. |
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| Liver Disease CRO Services | Product | Novotech | Biotechnology companies consider locations in the Asia-Pacific region, such as South Korea and China to access vast treatment-naïve patient populations and accelerate their clinical trials at lower costs. |
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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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