Country and Site Selection: Optimizing Protocol Planning Decisions by Leveraging Data Through Custom Algorithms

Do You Believe There is Room to Improve Your Approach to Selecting Countries and Sites?

In this webinar we will discuss best practices for using data to objectively assess the best fit countries and associated sites for particular trials. We will present methods for identifying key success factors for each country, options for measuring key success factors, and how to determine an optimal country strategy to ensure successful delivery of clinical trials. Highlighted will be the analysis, collection, determining data type and developing the right algorithm to help determine the best fit countries and sites for your trial / program.

The approaches will be demonstrated through a case study showing an example of how the appropriate tools, insight from data and approaches are applied in a real world setting.

By attending this webinar you will learn:

• Best practices for objectively selecting countries for inclusion in clinical trials and programs
• Develop and use algorithms to aide in choosing the best countries and sites for clinical trials and programs
• Learn how to determine appropriate data for inclusion and leverage data, knowledge and technology to identify the optimal countries and sites for trials
• Ultimately challenge current methods for selecting countries with data-driven insights And help you avoid costly delays and quality issues, ultimately saving you time and money and help you avoid costly delays and quality issues, ultimately saving you time and money.

Note: this presentation is not a solicitation for business, rather a challenge to the industry to think objectively and spend additional time / effort up front in planning their clinical trial strategies.

Speakers

Chris Frega, Senior Director and Head of Global Feasibility, Quintiles

Chris Frega oversees the Global Feasibility function at Quintiles and also lends strategic leadership and oversight to select customers and engagements. His department is an integral part of clinical trial design and planning and conducts analyses including rapid, data driven, comprehensive assessments of key factors for clinical trials and programs to assess how many patients are available in which locations over what period of time.

Mr. Frega’s key responsibilities include providing optimal country and site distributions, identification of pitfalls / minimization of study risks, and patient recruitment estimates & predictive modeling, all to ensure predictable success for each trial Quintiles runs. His team’s work spans all therapeutic areas and many indications with more than 1500 feasibility assessments conducted over the past 4 ½ years.

Mr. Frega holds a Bachelor of Arts degree in Business from St. John Fisher College and an MBA also from St. John Fisher College.

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Tom Larrichio, Senior Director, Strategic Site Intelligence, Quintiles

Tom Larrichio heads up Strategic Site Intelligence, which is a therapeutically aligned group focused on developing and helping deliver upon strategies that enable Quintiles to identify the optimal sites to support each unique study. Mr. Larrichio’s team leverages data, therapeutic and site knowledge, and applies analytics to deliver executable strategies. Previously, Mr. Larrichio led the Enterprise Data Council Office and was responsible for building and helping the organization execute on a Data Strategy, driving data quality improvements and building a data quality culture by establishing data standards and policies, and educating the organization via stewardship.

Prior to joining Quintiles, Mr. Larrichio was the CEO at BioMachines, Inc, a small biotech company that developed and manufactured equipment to support proteomics research, bio-terrorism, and nano-technology development. From 1999-2005, Mr. Larrichio was the VP of Business Development at TriVirix International. TriVirix was one of the first contract manufacturers and designers focused solely on Medical Devices. While at TriVirix, Mr. Larrichio helped build the company from a start up stage to robust annual sales through the combination of organic growth and acquisition. Prior to entering the Life Sciences industry, Mr. Larrichio held various roles in the Aerospace and Space industry at Honeywell, including Contract Management, Finance, Program Management and ultimately leading cross functional teams with P&L responsibility.

Mr. Larrichio attended the University of New Mexico where he obtained a Business Finance and Economics degree.

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