Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors

Date: April 4, 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
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:
  1. Best ways to audit a CRO
  2. When to audit and types of audit
  3. Defining scope and process for an audit
  4. Best ways to evaluate the impact of the audit findings
  5. What does FDA expect from a sponsor regarding vendor integrity
  6. Best practices for enforcing the Quality Agreement
  7. Pros and cons of working with large and small CROs, local and foreign CROs
  8. Best practices for interviewing, verifying data, and compliance to process
  9. Common mistakes in contracts and project management
Who will benefit:
  1. Clinical project managers
  2. Clinical operations
  3. Regulatory affairs personnel
  4. Quality assurance personnel
  5. Vice presidents, Directors and Managers
  6. Finance managers, legal and accounting managers
  7. People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com