Rho is committed to leading and contributing to the discussion around key industry topics and trends. Our experts have conducted a variety of webinars and are happy to share their considerable knowledge and expertise drawn from years of industry experience. Each of the following free webinars is an hour-long and can be viewed on-demand. See our News & Events page for information about upcoming live webinars.

Free Webinar: What Non-statisticians Need to Know about Statistics in Clinical Trials

Not everyone wants to be a statistician; however, in the clinical trials business, your understanding of statistics can make or break your program. Through real-world examples, webinar participants will learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes. Participants will also learn why planning for data collection is so important as well as tips for collecting the right data to answer your scientific questions. These tips and strategies are what every non-statistician should know about statistics in clinical trials.

Erika Menius, MS
Senior Biostatistician
Erika has provided statistical support for clinical trials in a wide range of therapeutic areas for more than six years. She came to the industry with a decade of experience in mathematics instruction, which she will use to share her love of statistics.

Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality

The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools for successfully executing risk-based monitoring.

Lynn King
Assistant Vice President Operations
Lynn King has 18 years of experience in drug development. She specializes in developing and overseeing operational strategy for clinical programs with a focus on site selection, subject retention, and targeted monitoring.

Rob Woolson JD, MS
Senior Biostatistician
Rob Woolson has 12 years experience in the analysis of complex data. He has conducted statistical analyses in all phases of drug development (Phase I through NDA) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas.

Capitalizing on Industry Standards in Clinical Research

Join co-hosts Rho and Medidata Solutions for this complimentary webinar to learn more about the latest developments in industry standards, as well as the role they play in the successful design, execution and conclusion of clinical trials.

Jeff Abolafia
Chief Strategist, Data Standards
Mr. Abolafia has more than 20 years of experience in clinical research and has successfully led multiple CTD/NDA submissions. He is the co-founder of the Research Triangle Park CDISC Users Group and a member of the CDISC ADaM and ADaM Metadata teams.

Joshua Pines
Senior Manager
Medidata Worldwide

Targeted Product Development: Personalized Medicine versus Orphan Product Development

The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan products.  New products must be positioned intelligently to take advantage of this legislation.  Join David Shoemaker, Ph.D. as he discusses the benefits of orphan product designation in the US, EU, and strategies for obtaining these designations for novel products.

David Shoemaker, PhD
Senior Vice President, R&D
Dr. Shoemaker has 25 years of experience in pharmaceutical development and has led the regulatory strategy for programs in many therapeutic areas. He has experience with all types of regulatory submissions and has moderated dozens of FDA meetings.

Cost Effective Data Standards Implementation: How to Integrate CDISC Standards into Your Product Development Strategy

Based on recent guidance from FDA, a data standards plan is now expected at the IND stage of development. Join David Shoemaker, PhD and Jeff Abolafia, MA as they discuss cost effective methods for integrating CDISC data standards into your overall product development plan.

                           

Jeff Abolafia
Chief Strategist, Data Standards
Mr. Abolafia has more than 20 years of experience in clinical research and has successfully led multiple CTD/NDA submissions. He is the co-founder of the Research Triangle Park CDISC Users Group and a member of the CDISC ADaM and ADaM Metadata teams.

David Shoemaker, PhD
Senior Vice President, R&D
Dr. Shoemaker has 25 years of experience in pharmaceutical development and has led the regulatory strategy for programs in many therapeutic areas. He has experience with all types of regulatory submissions and has moderated dozens of FDA meetings.

Stop the pain: Tips for increasing patient retention and decreasing missing data in analgesia clinical trials

Analgesic clinical trials often fail, even when we know the drugs work. Join Lynn King and Karen Kesler as they share real-world solutions for trial design, execution, and analysis that will increase patient retention, minimize missing data, and help you successfully navigate FDA’s new paradigm for clinical trials in pain.

Lynn King
Assistant Vice President Operations
Lynn King has 18 years of experience in drug development. She specializes in developing and overseeing operational strategy for clinical programs with a focus on site selection, subject retention, and targeted monitoring.

Karen Kesler, PhD
Senior Statistical Scientist
Karen Kesler has a Doctoral degree in Biostatistics from the University of North Carolina and over 15 years of clinical trial experience. A recognized expert in adaptive design, she is involved in researching more efficient Phase II & III trials.