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
Webinars
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.
Webinar
Expedited US FDA Development and Approval Programs for Serious Conditions
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.
Webinar
Hindsight is so 2020: Getting Ahead of CNS Trial Enrollment in a Rapidly Changing Clinical Landscape
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,
Webinar
Strategies to Avoid Enrollment Delays
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.
Webinar
Mitigating Covid-19 through a Hybrid Decentralized Clinical Trials Approach
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.
Webinar
CROs: The Tip of the Spear in Maximizing the Value of Hybrid, Virtual, and Synthetic Clinical Trials
Hybrid, Virtual, and Synthetic clinical trials are becoming a part of an increasing number of drug and biologics development programs. In this webinar, Rho experts discuss how their approach to maximizing the benefits of decentralized trials helps sponsors get the most out of their trials through offering solutions that bridge the gap across an ever-increasing number of data collection systems and
leverage the information real-time.
Webinar
Implications of Historical Control Studies for Rare Disease Products
Development programs in rare diseases are becoming a major focus for small biotech and pharmaceutical companies. A crucial consideration is the choice of control group used to assess efficacy. Through recent case studies, we will discuss factors to consider, appropriate analysis, and the critical role that externally controlled studies play in supporting marketing applications for orphan/rare disease products.
Webinar
Potential COVID-19 Products: Choosing the Right Path with FDA
If you are considering development of a product for treatment of COVID-19 or COVID-19-related indications, ensuring no time is wasted between idea and engaging FDA via the appropriate pathway with all the required information is essential. In this webinar, we’ll review the pathways you might consider, based on the development phase and overall goals for your product, and discuss the information and data necessary to help FDA expeditiously review your proposal and move it forward.
Webinar
Managing the Risks of Implementing E6R2
Successful implementation of RBQM is a challenge many in our industry are facing. To understand what it is and how it impacts the management of your clinical trial, this webinar will address what exactly E6R2 is. We will use Rho as a case study for designing and implementing a strategy, discuss common misconceptions, and review lessons Rho has learned through implementation of RBQM.