Rho Webinars

  1. Mitigating COVID-19 Risks In A Complex Pain Program: A Sponsor And CRO Perspective 5/25/2021

    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.

  2. Expedited US FDA Development And Approval Programs For Serious Conditions 3/10/2021

    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.

  3. Hindsight Is So 2020: Getting Ahead Of CNS Trial Enrollment In A Rapidly Changing Clinical Landscape 12/11/2020

    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 the webinar to hear experts discuss their approach to adapting CNS trial enrollment to a rapidly changing clinical landscape.

  4. Strategies To Avoid Enrollment Delays 10/21/2020

    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.

  5. Mitigating Covid-19 Through A Hybrid Decentralized Clinical Trials Approach 10/15/2020

    The covid-19 pandemic has presented the industry with many risks and challenges to the 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.

  6. CROs: The Tip Of The Spear In Maximizing The Value of Hybrid, Virtual, And Synthetic Clinical Trials 9/2/2020

    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, leverage the information real-time, and bring this information to bear on business decisions, clinical trial execution decisions, and marketing application dossiers.

  7. Potential COVID-19 Products: Choosing The Right Path With FDA 7/16/2020

    Information is being shared by FDA in an ongoing fashion as they manage the response to the current COVID-19 pandemic for ongoing and planned clinical research. In this webinar, we’ll review the pathways you might consider, based on the development phase and overall goals for your product, and discusses the information and data necessary to help FDA expeditiously review your proposal and move it forward.

  8. Implications Of Historical Studies For Rare Disease Products 7/16/2020

    Development programs in rare diseases are becoming more common and a major focus for small biotech and pharmaceutical companies. A crucial consideration in clinical study and protocol design in these indications is the choice of control group used to assess the efficacy of an intervention.

  9. Are You Really Ready For Your End Of Phase 2 (EOP2) Meeting? 4/21/2020

    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.

  10. Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access 1/29/2019

    Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.