Clinical Trial Outsourcing - Request For Proposal (RFP) Process

Launching March 31, 2021!

Pre-register for early-bird pricing today.

Course Description

This course will cover the clinical trial outsourcing request for proposal (RFP) process and how to manage end-to-end qualification and RFP process for clinical provider selection. The course content and modules will include a mixture of video, slides, quizzes, helpful course materials and bonus content. Upon successful completion of course materials and quizzes, course takers will be eligible to access and print a certificate of completion.

Course Objectives

Educate on core elements of the service provider engagement, qualification, and selection process

· RFI Process

· RFP Process

· Due diligence best practices

Special considerations by service provider type

· CRO- full/hybrid outsourcing

· Technology (system) suppliers

· Miscellaneous (3rd party) suppliers

Topics Covered in Course

· Outsourcing Goals

· Relationship Goals

· Outsourcing Strategies

· Outsourcing Tactics

Qualification / RFI Process

Study Selection / RFP Process

· RFP Objectives

· RFP Process Overview

· RFP Project Definition

· RFP Study Assumptions

· RFP – RACI / Service Needs

· RFP – Service Assumptions

· RFP – Budget Grid

· RFP – Questions

· RFI – Requests

· RFP – Selection Criteria

· RFP – Best Practices

Award to Contract Process

Audience

Primary Audience: Clinical operations, clinical development, clinical outsourcing. accounting, finance and other supporting roles within pharmaceutical and biotech clinical study sponsors and clinical research organizations (CROs).

Additional Audience: Those from Clinical Trial and Research Industry.


Your Instructor


Debora S. Araujo
Debora S. Araujo

Débora S. Araujo has over 15 years of experience in the pharmaceutical industry working and consulting for Fortune 500 companies.During her time in this industry her special focus has been on the business aspects of clinical trials including clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments.

In 2018, Débora founded ClinBiz®, an innovative educational platform for clinical trial professionals to remain connected and updated on the latest topics, trends and technologies surrounding the business aspects of clinical trials.Utilizing a forward-thinking and digital approach, ClinBiz® has become an educational reference to clinical trial professionals navigating industry pain points surrounding global clinical site and vendor contract negotiations, fair market value (FMV) issues, outsourcing best practices, vendor contract oversight, clinical trial budgeting and forecasting, investigator site payments, clinical business operations, among other clinical trial business topics.

ClinBiz® has expanded to provide online self-paced educational courses, niche consulting and an annual conference.


Continuing Education

Course takers are encouraged to submit course description, course length and course agenda directly to their specific certification associations to confirm course completion will be accepted as part of their continuing education requirements.

Requirements for SOCRA's Re-Certification Continuing Education for Web Based/Online Coursework:

Agenda AND Certificate of attendance and/or letter signed by supervisor. Course Agenda and Certificate of Attendance (at course completion) will be provided to our course takers.

Requirements for ACRP Re-certification Continuing Education

Please contact ACRP directly with this course title, timed agenda/course overview, and objectives included on this page for their approval as a continuing education course in your re-certification.

Frequently Asked Questions


When does the course start and finish?
The course starts March 31, 2021. It is a completely self-paced online course - you decide when you start and when you finish.
How long do I have access to the course?
After enrolling, you have unlimited access to this course for as long as you like and the course is available - across any and all devices you own.
What is the refund policy for courses?
The courses are non-refundable.
Will I have access to course updates?
Absolutely yes! You will pay only once for this course but you'll receive access to any and all future updates as long as the course is available.

Get started now!