CRO Selection and Oversight – A Risk-Based Approach

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials (GCP Training)/ Medical Device Training/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders.  This includes procedures for selection and oversight of CROs and other vendors.  Every process – from vendor selection and establishing preferred vendor programs, to study project reports, communication plans, and project escalation – requires a high degree of risk-based diligence to satisfy regulators.

As industry becomes more reliant on outsourcing clinical research activities, outlining clear roles and responsibilities between CRO and sponsor regarding who assesses, monitors, and documents risk management activities is critical to both compliance and study success.  Understanding these roles and designing/executing effective risk-based vendor strategies will separate successful firms from those who will fail.

Come to this interactive live session and you will be able to:

  • Identify the risk-based study management approaches to CRO oversight
  • Recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management
  • Build a risk-based assessment tool  for CRO management
  • Identify key approaches to planning and preparing to outsource

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved with the selection, procurement, and management of Contract Research Organizations (CRO) on both the sponsor or vendor side.  Additionally, those involved in regulatory submissions or who need to be conversant in roles of sponsor firms or vendors will find this course highly useful.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

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