Now Available for Purchase: CRO Oversight Training

2/09/2021

Sponsors outsourcing clinical trials tasks is nothing new, but how does the sponsor ensure CROs and vendors understand which duties or activities they are conducting and how to provide quality services? Regulatory authorities require sponsors to oversee the quality of the work that CROs or vendors working on behalf of the CROs complete. Good oversight means a supportive partnership that should be established and defined early on.

CRO oversight is a topic that is important to all sponsors that are outsourcing clinical trial duties or activities to support the factors that are critical to success of their product development. Sponsors outsource for many reasons, including but not limited to, meeting the temporary need for a large expanded workforce, additional and sometimes unique expertise, technology, and quality systems. To make these partnerships work, sponsors must have systems in place to oversee the quality of the CRO’s work for the protection of study participants and also the reliability of the data.

Introduction to CRO Oversight lecture video training is now available for purchase in our online store HERE. The training provides an overview of the key concepts and best practices for CRO management in a global clinical trial setting. The training also includes information about the global regulatory landscape regarding CRO management, primarily focusing on EMA, FDA, and ICH E6(R2).

Objectives

  • Describe the Sponsor regulatory requirements for use of CROs.

  • Recognize key components for effective Sponsor CRO oversight.

  • Identify adequate CRO oversight procedures, oversight plans, and documentation management.

Includes:

  • Unlimited access to the content for 45 days from your initial day of purchase.

  • Video lectures

  • Helpful resources

  • Knowledge Checks after each content area

  • Certificate of completion

Audience

A foundation training applicable for all sponsor clinical team members and contractors.

Customization Available

A more detailed and customized course can be developed for sponsors for in person or online workshops, as well as additional development of customized graded post assessments and scenarios. Full LMS compatibility with SCORM packages available. Contact us at info@clinicalpathwaysresearch.com for additional information or to arrange a meeting to discuss.

Enterprise Pricing Available

Off the shelf pricing for over 10 licenses from the store is available when you contact us at info@clinicalpathwaysresearch.com.

Want training for longer than the license timeframe but do not have an LMS? Clinical Pathways can host annual training in our LMS to support your learners, with reports and certificates of completion for audit readiness.

 

- The Clinical Pathways Team

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