Rho, a privately held, contract research organization (CRO) located in Research Triangle Park, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Facebook, LinkedIn and Twitter.

WEBINARS

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

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. In this webinar, we will discuss what risks and challenges COVID-19 has presented, ways in which these can be addressed.

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.

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.

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.

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.

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.

This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development

Dr. Jack Modell discusses why there is more to the story than placebo response in regards to the high failure rate of clinical studies in depression. Identify other factors that can contribute to failures and what steps can be taken to avoid those pitfalls.

How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.

While we can’t predict the outcome, planning ahead for appropriate site and subject selection will take you one step closer to ensuring the successful conduct of a study. From study design to logistics to recruitment, this webinar will look at the key differences between studies conducted in pediatric populations and studies conducted in adult populations.

This webinar will explore the rationale for implementing patient-centered practices and offer guidance for initiating patient-centered approaches to research. Review practical strategies for engaging patients in the clinical trial process without sacrificing research quality or adding untenable costs to your trials and understand which factors matter to patients and how to design trials that honor their needs and desires.

Whether indications of fraud appear as missing documentation, altered numbers, signatures that don’t match, or unavailable medical records Clinical research associates (CRAs) must be aware of the many signs of possible fraud or fabricated data occurring at a clinical trial site. This webinar explains the signs to look for and the proper protocol to handle and report the misconduct during each monitoring visit.

Marketing application submissions, including NDAs, biologics license applications (BLAs), and premarket approvals (PMAs) in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you navigate submissions in the most efficient and effective way.

This webinar will provide advice on how to set your small company up for long-term success through the use of strategic development plans, purposeful outsourcing, patent protection, partnership strategies, and provide specific examples of success stories and lessons learned.

This webinar will provide an overview of the clinical, nonclinical, CMC, and regulatory activities necessary for a successful IND submission.

This webinar includes tips to help quality, project management, clinical, and site personnel manage conflicts as well as a review of the applicable regulations and reporting requirements.

CONTACT INFORMATION

Rho

2635 E. NC Hwy 54

Durham, NC 27713

UNITED STATES

Phone: (919) 408-8000

Fax: (919) 408-0999