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| Impact Of Research Misconduct Updates On Clinical Trial Sponsors | Guest Column | By Darshan Kulkarni, Pharm.D., Kulkarni Law Firm, Clinical Leader | The Office of Research Integrity (ORI) has proposed updates to the Public Health Service Policies on research misconduct. Darshan Kulkarni outlines how the proposal should influence sponsors to reevaluate existing trial practices. |
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| Reporting Unexpected Incidents To The IBC | Article | By Daniel Eisenman and Scott Swindle, Advarra | Utilize this comprehensive guide to better understand reportable incidents and the appropriate channels for communication when unforeseen events arise. |
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| Studying The Effects Of Drugs On Driving | Article | Altasciences | For CNS drugs that need assessment of their impact on driving ability, Altasciences offers faster study start-up and lower costs with on-site driving simulators. |
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| Strategic Regulatory Documentation Practice | Brochure | inSeption Group | Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities. |
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| Regulatory Affairs And Drug Development Solutions | Datasheet | IQVIA Safety & Regulatory Compliance | Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services can help reduce time, cost, and risk, from discovery through post-registration. |
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| Development To Commercialization And Beyond | Article | PCI Pharma Services | Explore how a CDMO with global capabilities and flexible solutions can help reduce time-to-market, mitigate supply chain risks, and meet global demands while bringing a product to market. |
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| 4 Ways FSP Models Are Being Used To Drive Success | White Paper | PPD FSP Solutions | Dive into several case studies where clients have leveraged clinical research services to surmount critical challenges within the industry and accelerate their achievements. |
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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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