Avoid Data Integrity Issues: How to Audit a CRO and Other Vendors
Date: April 4, 2025
Duration: 60 Minutes
Time: 12 PM EST
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.
- 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
- 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
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
We accept credit card, debit card, and PayPal.
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.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
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.
