CRO Oversight: Practicalities, Roles and Responsibilities Discussion

Duration: 60 Minutes
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.
CRO Oversight
Instructor: Laura Brown
Product ID: 509299
The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses monitors and documents risk management activities is critical to both compliance and success. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring audit readiness.

Objectives of the Presentation
With Regulatory Inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming increasingly important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company's ability to identify and select the right CRO / vendor for the right project and manage them efficiently and effectively will help to ensure compliance with the Regulator's expectations.

In this course you will learn:
How to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R & D projects you need to outsource. This course also covers the techniques for successfully managing CROs / vendors and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be discussed.

Why Should you Attend
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing clinical trials to remain compliant.

Using a combination of theory and practical examples, this interactive course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge you need to ensure quality oversight.

Areas Covered
  • Understand how to effectively manage CROs / vendors used in the pharmaceutical industry
  • Build an understanding of your responsibilities as the sponsor or the vendor: identifying the right level of oversight
  • Discover tools and processes to manage CROs and other vendors
  • Gain an insight for CROs/other vendors of what sponsors expect and how to meet their expectations
  • Measuring CRO performance including metrics and key performance indicators
Who will Benefit
This course is designed for personnel involved in vendor/CRO oversight (including those working in Clinical Research, Regulatory Affairs, Pharmacovigilance, and Manufacturing ) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs) , Vendor Management, Global QA/Compliance, Contracts and Outsourcing. VPs, Directors, Managers and other personnel involved in selecting and managing CROs will benefit from this course. Outsourcing department staff, purchasing, finance and contract management staff who participate in the Request for Proposal (RFP) process will find this course a valuable introduction or refresher course focusing on best practice.
$375
Recorded Session for one participant
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Live Session - How it works
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr Laura Brown is an independent pharmaceutical QA and training consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff. Laura is an expert in outsourcing pharmaceutical research projects including CRO selection, audit and management. She has more than 20 years' experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International in outsourcing pharmaceutical projects. She has worked in several vendor selection and management roles which have included reviewing quality and performance of CROs and has advised companies on how to implement quality systems for CRO selection and management.
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