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Blog Post
Data Collection in Decentralized Clinical Trials
Information discussing the transition to DCTs and their challenges, alongside the integration of data collection technology and best practices for sharing DCT data.
Blog Post
505(b)(2) Bridging Studies
While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.
Webinar
Using Advanced Data Visualization To Power Up Clinical Trials
It’s in the collective best interest of research sponsors, participants, and sites to get clinical trials up and running faster and with the right safety surveillance mechanisms in place. But all too often, challenges and complexities stand in the way of efficient trial activation, enrollment, and post-activation monitoring.
However, there’s an opportunity to overcome these barriers with a reimagined take on data reporting: We know that existing data can get lost and underutilized beneath piles of raw numbers. That’s where data visualization comes in—giving datasets the structure they need to be seen and put to action for more efficient clinical research.
Blog Post
Nonclinical Considerations for Gene Therapy Products
The development of a gene therapy (GT) product has many considerations that differ from those of a traditional biologic or new chemical entity (NCE) program.
Webinar
Partnering for Success: Doing Study Start-Up Right in the Context of Decentralized Studies
Study start-up sets the foundation for success of your clinical trial. There are many considerations for vendor selection and partnerships during development and start-up. With these come challenges: complex protocols, gaps in site expectations, problems with enrollment and retention, etc. To combat these challenges and improve the chance for success there are several important concepts to keep in mind in the context of decentralized trials.
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