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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.  

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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.

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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.

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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.

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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.

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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.

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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.

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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.