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Blog Post
Estimands: An insight into the new framework
An estimand framework has been presented by the ICH in November 2019 and the FDA in May 2021 to provide clarity on defining the reported treatment effect. This blog post summarizes the key components to the estimand framework that are covered in the ICH E9 (Revision 1) addendum on estimands and sensitivity analyses in clinical trials, as well as the supporting FDA guidance and ICH training material.
Webinar
Accelerating Clinical Development with Expanded Access
Expanded Access can be leveraged to advance and even accelerate clinical development of treatments for serious or life-threatening conditions. This webinar examin
Case Study
Successful Submission of a Complex NDA for a Breakthrough Therapy- Designated Product
Successful NDA submissions require a foundational regulatory and clinical strategy that can adapt to the challenges and competing priorities of the drug development process and ultimately drive the program forward. Read our case study to learn more about the approaches and activities we implemented to meet timeline goals
Article
Clinical Studies Required for a 505(b)(2) Development Program
A very common yet very critical question for a 505(b)(2) development program is “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program.
Webinar
Mitigating COVID-19 Risks in a Complex Pain Program: a Sponsor and CRO Perspective
UNITY Biotechnology partnered with Rho to execute a complex and fast-moving Osteoarthritis program with three concurrent clinical trials and database locks scheduled during the height of the COVID-19 pandemic. In this webinar, hear from both the Sponsor and CRO about the creative solutions they implemented and how they worked together to pivot quickly and meet critical study timelines in the midst of the pandemic.
Blog Post
Inspection & Audit Preparation in Decentralized Trials
To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. We have outlined several areas for consideration to ensure audit readiness from start-up through submission.
