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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.

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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.

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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.

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Webinar

Challenges with Fast Enrolling Post-Operative Acute Pain Studies

There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly?  Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution. 

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Webinar

Regulatory Agency Meetings – Your guide to EOP2 meeting preparation

The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission.  Companies nearing completion of their phase 2 studies or who are planning phase 3 programs will benefit from this webinar.