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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.

Rho_Resource_Blog
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.

Rho_Resource_Webinar
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.  

Rho_Resource_Blog
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.

Rho_Resource_Webinar
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.

Rho_Resource_Blog
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.

Rho_Resource_Webinar
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