Clinical Trial Outsourcing - Request For Proposal (RFP) Process

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.