Webinars >>Clinical Research
Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors 

Undetected data integrity issues at a vendor, CRO or otherwise, is a costly mistake for a sponsor. While vendors perform critical functions and offer several advantages over DIY models, an unsupervised vendor would likely lead to data integrity issues and the associated pain. As a general rule, it is the responsibility of a sponsor to assure that data integrity issues at a vendor. CROs are the biggest and most challenging vendors as they control the longest running and most expensive projects. That is followed by GMP vendors. Once the clinical trial is underway, it is necessary to audit the CRO at least at three milestones. Each audit is distinct in its scope, process, and impact. Similarly contract manufacturers need to be audited at defined milestones to assure constant supervision and early detection of compliance and data integrity issues. This webinar will discuss all the above issues and many more based on industry best practices and FDA expectations.
Why should you attend:
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This webinar, presented by a leading expert on CROs, will discuss factors to consider when choosing a CRO. The seminar will discuss critical things such as how to design the best RFP, scouting for potential CROs, how to evaluate referrals, best practices for the CRO interview process, budget and time-line negotiations, GCP audits, quality agreements, project management, and many more. The webinar will provide precise and complete list of measures and checklists to help you find the best CRO for your trials. If you are new to planning clinical trials or if you have done it a few times, this webinar will give you tips to make your next selection better and ways to evaluate your current CROs.
Areas Covered in the Session:
  • Best ways to audit a CRO
  • When to audit and types of audit
  • Defining scope and process for an audit
  • Best ways to evaluate the impact of the audit findings
  • What does FDA expect from a sponsor regarding vendor integrity
  • Best practices for enforcing the Quality Agreement
  • Pros and cons of working with large and small CROs, local and foreign CROs
  • Best practices for interviewing, verifying data, and compliance to process
  • Common mistakes in contracts and project management
Who will benefit:
  • Clinical project managers
  • Clinical operations
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • Finance managers, legal and accounting managers
  • People interested in investing in the FDA-regulated industry
Date: January 16, 2020
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com