Outsourcing Preclinical Toxicology Studies

This course is ideal for those in pharmaceutical and biotechnology companies who are involved in or support outsourcing preclinical toxicology studies including but not limited to:

• Toxicologists – pharmaceutical and biotechnology companies
• Outsourcing professionals
• Senior and operational management
• Procurement personnel
• Quality assurance professionals
• Clinical veterinarians
• Consultants
• CRO management and scientists
• CRO business development and client services personnel

Learning Objectives

Attendees will learn how to how to evaluate their outsourcing needs and how to develop a cost-effective strategy that will lead to a successful outsourcing experience. Participants will receive detailed instruction on how to inspect, select, and build relationships with a CRO.

Course Description

The course will address ways to identify contract research organizations (CROs) who can meet these needs and will include evaluation tools, information sharing of real life outsourcing experiences, interactive exercises, and daily opportunities for Q&A.

Upon completion of the course, attendees will have a much better understanding of methods to promote teamwork and improve effectiveness within pharmaceutical and biotechnology companies by aligning the understanding of outsourcing operations among personnel in the multidisciplinary departments that support this activity. Senior management and operational personnel can learn how to better understand outsourcing resource requirements and how to manage risk.

This course is also beneficial for CRO management, scientists, and business development personnel who want to better understand outsourcing customer’s needs and expectations. The course outline is flexible so it can be adjusted to the specific needs of attendees. The course instructor will be available before and after class to consult on any participant projects. The course also provides the following:

• Industry trends in preclinical outsourcing
• How to increase productivity in a toxicology research component
• Study monitoring at CROs
• Small class size (20 or less) insures individual attention

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COURSE AGENDA

DAY ONE

Outsourcing Strategies

• Why do companies need to outsource
• What do companies hope to accomplish by outsourcing
• What type of work should be outsourced
• What outsourcing strategy should be used
• What is required to implement an outsourcing strategy
• Internal barriers to outsourcing

Identifying, Evaluating, and Selecting a Contract Research Organization

• What do you need from a CRO
• What should you look for in evaluating a CRO
 operational assessments
 regulatory assessments
 personnel assessments
 facility assessments
• The CRO Prequalification Visit

Information Sharing - Real Life Examples of CRO Prequalification Visits

Questions and Answers

DAY TWO

Evaluating CRO Marketing and Business Development Themes

Selecting a CRO

The Transition from Vendor Selection to Actual Outsourcing

• What internal resources are required
• What information is needed by the CRO
• The importance of aligning the internal departments that support outsourcing

Building and Maintaining a Successful Sponsor-CRO relationship

Information Sharing - Real Life Examples of CRO Selection Decisions and CRO Relationships

Questions and Answers