Personalized medicine has a complexity problem. In Parkinson’s, this complexity problem is far-reaching and access-limiting. Dr. Schmidt presents his insight from bench research, clinical trials, and care workflow optimization to explore how optimized clinical trials can expand access, improve care, and pave the way for more regionally diverse innovations in Parkinson’s.
Join Rho, Altreos, and Dr. Vince Clinical Research as our experts discuss important aspects of designing and conducting Human Abuse Liability/Human Abuse Potential (HAL/HAP) clinical studies to satisfy FDA’s expectations and guidance for abuse liability assessments.
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.
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.
Expanded Access can be leveraged to advance and even accelerate clinical development of treatments for serious or life-threatening conditions. This webinar examin
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.
The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program.
The past six months have highlighted both existing and unexpected enrollment challenges, as sponsors, CROs, and sites have been pressed to evolve their recruitment strategies. Join us as Rho experts discuss their approach to adapting CNS trial enrollment to a rapidly changing clinical landscape,
Completing enrollment is typically one of the most critical milestones in a clinical trial. Enrollment delays impact the study budget, site resources, and downstream timelines. Therefore, it is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible. Defining risk mitigation strategies and setting quality tolerance limits allows the study team to quickly identify when a strategy must be implemented to keep enrollment on track. In this webinar, we will discuss how we have used a risk-based quality management system to document enrollment risks and creative solutions we have implemented.
The Covid-19 pandemic has presented the industry with many risks and challenges to the management of clinical trials. For many, the mitigation of these issues has accelerated the implementation of decentralized approaches to monitoring and management of clinical trials. In this webinar, we will discuss:
what risks and challenges COVID-19 has presented, ways in which these can be addressed, and
Rho as a case study.