|
|
|
|
| IRB in Action: A Live Mock Board Review offers a behind-the-scenes look at the IRB review process through a live mock board meeting led by experienced IRB members and clinical research experts. Attendees will observe protocol evaluation, risk-benefit discussions, informed consent review, and regulatory considerations while gaining practical insights to improve IRB submissions, protocol development, and study readiness. |
|
|
|
| From The Lab To Regulations As An IRB Specialist | From The Editor | By Dan Schell, Chief Editor, Clinical Leader | In this 8-question Q&A, Ribu Goyal, an IRB specialist and scientific reviewer at the Mayo Clinic Office for Human Research Protection, talks about everything from the details of her job to how sponsors could improve their collaboration with their IRBs. |
|
|
| What Sponsors Get Wrong When Selecting A CRO | Article | Dash Bio | Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results. |
|
|
|
| Open-Label Study Assessing Relative And Absolute Bioavailability | White Paper | By Andy Sykes, Helena Engman, Nigel Taylor, et al., Quotient Sciences | Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions. |
|
|
| Ready To Reach Proof Of Concept Faster? | Product | Altasciences | Proof-of-concept provides a critical bridge between Phase 1 and Phase 2 trials, making an experienced CRO partner vital to achieving optimal outcomes for early-phase clinical research. |
|
|
| The Next Generation Of Oral Targeted Therapies | Brochure | PCI Pharma Services | Solve the unique challenges of poorly soluble molecules like targeted protein degraders (TPDs), such as PROTACs and molecular glues, seamlessly accelerating your molecule from development to commercialization. |
|
|
|
|
| Strategic Implications Of The Single Phase 3 Approval Paradigm | Case Study | By Peter Schmidt, Ph.D., and Sheldon Preskorn, M.D., Dr. Vince Clinical Research | As FDA single-trial approvals gain traction, CNS developers need stronger early evidence. Learn how biomarkers, patient selection, and regulatory strategy can accelerate development. |
|
|
|
| At The Turning Point – Shaping The Future Of Hematology | E-Book | By Heidi Cho, M.D., Parexel International | Hematology is at a turning point. Turn complexity into strategy with smarter trial design, stronger patient engagement, confident regulatory navigation and real-world evidence insights. |
|
|
| Driving Safety And Compliance Seamlessly | Datasheet | IQVIA Safety & Regulatory Compliance | Whether it’s accelerating market entry with the “FSP Country in a Box” solution or maintaining global compliance through expert oversight, IQVIA empowers organizations with scalable, localized support. |
|
|
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: |
|
|
|
