|
|
|
|
|
| Mimicking The Hollywood Mindset To Develop Drugs | Guest Column | By Siddharth Parulkar, PAR Clinical | Traditional organizational structures often struggle to adapt to the dynamic nature of drug development; consultant Sid Parulkar offers another approach that borrows from the Hollywood film industry. |
|
|
| A Streamlined Approach To 14C Human ADME Studies | Article | Quotient Sciences | Understand the benefits of a program that allows for a flexible approach to human ADME studies and the breadth of supporting data and case studies that demonstrate both significant time and cost savings. |
|
|
|
|
|
|
| Day One Bio's Talks With FDA Help Secure Glioma Drug Approval | Guest Column | A conversation with Elly Barry, MD, Day One Biopharmaceuticals | Day One CMO Elly Barry, MD recounts the company's experience working with the FDA and turning a passed-over drug into its first-ever approved treatment for pediatric glioma. |
|
|
|
|
| Understanding Safety Tactics, Regulatory Considerations In JAPAC | White Paper | By Hye Jin Choi, R. Ph. and Dr. Jayawant Fuke, IQVIA Safety & Regulatory Compliance | As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance. |
|
|
|
| Get The Facts: NDA-Enabling Studies | Brochure | Altasciences | Need help with inclusion/exclusion criteria for your Phase 2/3 protocol or an unexpected FDA post-marketing amendment? Altasciences offers reliable solutions with a quick start-up. |
|
|
CHOOSE YOUR OWN ADVENTURE |
|
|
|
| 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)
Learn more about our personalized newsletters here. |
|
|
Connect With Clinical Leader: |
|
|
|