CRO, CDMO and Non-Clinical Vendor Management Fundamentals

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    "The Course Director provided many ideas for our company to consider; she is an excellent instructor! Very down to earth, friendly, knowledgeable. Willing to help in any way possible - both in and outside of the course. I wish every class was taught by her!" 


    Sherri C., Clinical Research & Training Coordinator, Micro Vention

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    "Excellent, on point - very useful. Instrcutor was an excellent, energetic speaker. She has a wealth of knowledge that provides insight." 


    Julie G., Regulator and Clinical Specialist, Compliance Insight

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    "The course material was very relevant to my area of expertise. The discussions were engaging and many useful ideas were exchanged. This was further enhanced by the diverse background of the participants. I would recommend this course to others." 


    John P., Sr. Clinical Scientist, Shire

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Description

This training course will provide the attendees with the tools and techniques needed to outsource different development processes, services, and functions. The learning goal is to add consistency and quality to the process of identifying exactly what needs to be outsourced (and what should not), how to put a quality process in place to choose the best vendor and management techniques to ensure a successful relationship and outcome with that vendor, once they are brought into the organization.


The Request for Proposal (RFP Process) is reviewed in detail and templates provided. Different types of vendors and the tools and techniques used with each will be discussed. Clinical Research Organizations (CRO’s) needed to run Phase 1 – 3 clinical studies and Clinical Development and Manufacturing Organizations (CDMO’s) needed to produce Drug Substance/Drug Product will be reviewed in detail. Non-clinical vendors who perform animal studies required for both IND and NDA submissions will also be discussed.


The importance of Contracts, Quality Agreements and Key Performance Indicators (KPIs) will be discussed for different types of vendors and examples provided. Communication tools to develop and forge strong working relationships with your vendors will be provided and practiced during class. The merits of oversight activities like pre-qualification visits and audits (remote and in-person) will be compared and risk analysis discussed in detail.

Who Should Attend

This training course is designed for personnel in the pharmaceutical, biotechnology, and medical device industries who use vendors to produce any, or all, of their product. A basic knowledge of the industry you work in and the standard development process for that product is helpful for this course.

Anyone participating in the selection and/or management of vendors (from the Vice President level down), will benefit from this comprehensive look at the processes involved. Outsourcing department staff and purchasing, finance and contract management staff will find this course a valuable introduction or refresher. Administrative staff involved in operations and business development functions will gain an understanding of what our industries expect from vendors and learn how to determine how well they deliver.

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  • Learning Objectives

    The challenge facing drug and device developers today is to maintain or increase product quality while reducing costs and development lead times.   A company’s (and their employee’s) ability to identify and select the right vendor for the right job, manage that vendor efficiently and effectively, will help them meet this challenge.

    • Learn how to write a Request for Proposal (RFP), run the process to choose your vendors and learn how to get and keep finance, legal and purchasing on your team.
    • Understand what documents you need to have in place with each type of vendor and how to clearly state expectations and roles/responsibilities.
    • Learn how to do a risk assessment based on the services/supplies for which you are contracting.
    • Establish your vendor team, communication guidelines, KPIs and expectations for your vendors and your internal team members.
    • Ensure you have the right level of oversight for each vendor.
    • Practice Lessons Learned to continuously improve your process of bringing in vendors.

  • Course Outline

    History of Outsourcing


    Why & What to Outsource?


    Selection Criteria


    Outsourcing Strategies


    The RFP Process


    Contracts & Other Key Documents


    Metrics (KPIs)


    Risk Mitigation 


    Vendor Communication & Oversight


  • Testimonials

    "This training course was very thorough and comprehensive.  The Course Director was a phenomenal instructor. Polished delivery, great energy and extremely knowledgeable."

    Ryan M., Senior Manager, Procurement, Notch Therapeutics


    "The instructor provided many ideas for our company to consider; she is an excellent instructor! Very down to earth, friendly, knowledgeable. Willing to help in any way possible - both in and outside of the course. I wish every class was taught by her!"

    Sherri C., Clinical Research & Training Coordinator, Micro Vention


    "Excellent, on point - very useful. Kay was an excellent, energetic speaker. She has a wealth of knowledge that provides insight."

    Julie G., Regulator and Clinical Specialist, Compliance Insight, Inc.


    "The course material was very relevant to my area of expertise. The discussions were engaging and many useful ideas were exchanged. This was further enhanced by the diverse background of the participants. I would recommend this course to others."

    John P., Sr. Clinical Scientist, Shire

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.