Regulatory Signal Brief
Report List
Choose from the available reports below.
Free Sample Reports → Click “Request Free Sample” and fill in the form. You will immediately receive an email containing the download link.
Paid Reports → Click “Proceed to Purchase Full Report” to open the pre-payment instruction page. You will then be directed to the Stripe checkout page. After the payment is completed, please proceed to the Report Receipt Form, where you can enter your information. Once submitted, your secure download link will be generated.
The New Standard in Clinical Trials – ICH E6(R3)・Qbd and Applied Areas (DCT・RWD・AI) – Dec 2025
A complete, three-layered view of the new regulatory landscape from ICH E6(R3) implementation to the re-defined QbD approach, and practical use of DCT, RWD, and AI. Includes Japan-specific considerations and PMDA expectations.