Performing a Remote Audit of your EDC Vendor

There has been a great deal of discussion lately on remote trials, remote monitoring, e-consent, etc., in the context of COVID-19. Another great topic worth discussing is remote auditing. Sponsors and CROs typically conduct on-site audits of their EDC vendors on a bi-annual or tri-annual basis, but what if that can’t be done on schedule? Add in the fact that experienced auditors are amongst the most vulnerable population, and the need for an alternative becomes painfully obvious. 

Recently, Prelude Dynamics has experienced an increase in Requests for Information and Vendor Qualification Questionnaires. Instead of becoming overwhelmed by filling in the same information multiple times, we have come up with a solution to streamline the process. We created a proprietary Remote Audit Response document for distribution to our Sponsor and CRO clients. It is a comprehensive document which will provide a suitable baseline for remote audits going forward. If you’re interested in receiving a copy, Contact Us. 

Remote Audit Checklist

We recently attended a webinar on the topic of remote audits so that we could provide helpful information to our Sponsor and CRO clients. Here are the most important tips we learned:  

Use a risk-based approach to identify providers to audit 

  • The FDA uses a risk formula to determine inspection priorities. 
  • It may be appropriate to assess less risky organizations and sites using a questionnaire. Software-as-a-Service (SaaS) providers are very good candidates for remote audit. 
  • Consider auditing 10% of the riskiest providers. The complexity of the service provided and proximity to market (GMP) factor into risk. 

Establish protections for Intellectual Property and methods of communication and data transfer. 

  • Non-Disclosure agreements protect both Sponsors/CROs and vendors and promote the flow of information. 
  • Test web-based video teleconferencing platforms and data transfer mechanisms in advance. 

Conduct the remote audit in phases. 

  • Ask the provider for an initial set of documentation and use that as a basis for a second request for information. Establish a deadline for submittal. 
  • The initial set should include indices (such as an SOP list), Organization Charts and Quality Manuals. 
  • Plan subsequent phases to address issues and questions that remain after the initial set has been reviewed. 

Formulate and communicate the agendas for additional phases in advance. Both parties should confirm receipt of all audit related communications. 

  • Requests for information should not be all inclusive. Request subsets such as specific training records, validation results and backup and restore evidence. 

Conduct opening and closing meetings to review status and remaining agenda items. 

  • If interviews with specific personnel are required, collaborate on scheduling. 

Conduct a closeout meeting to discuss observations. Only assign severities in the final report. 

  • Set realistic timeline for audit response. Define how results of any CAPAs will be reviewed (e.g., video telecon, copies of documentation). 

We are ready to collaborate with you on your next remote audit of Prelude Dynamics! 

Prelude Dynamics offers process improvements to help you cope with this new normal. Prelude Dynamics

 

 

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Prelude Dynamics Releases New ePro Mobile Application.

Prelude Dynamics, LLC, has announced the release of their new VISION ePro mobile application. This application enables patients to input data directly into the electronic data capture (EDC) system on their phone for a simpler and more efficient clinical trial experience.

Traditionally, personnel have had to expend a great deal of effort to get patients to follow through with their part in trials. It is difficult for patients and other infrequent users to navigate EDC systems as they can be complex and difficult to use without proper training. The extra effort it takes to follow up with these kinds of users has translated into higher costs for sponsors and monitors. VISION, Prelude’s renowned EDC platform, is one of the most intuitive and user-friendly systems for electronic data-capture on the market today.

Prelude continues to develop products like the ePro mobile application that will make their clients’ clinical trials more efficient than ever. Patients and pet owners participating in clinical trials can now navigate the VISION software with more ease and reliability, and the costs for trials are projected to go down as Prelude continues to enhance this new capability.

As the developers of VISION, the #1 EDC software system in Animal Health, Prelude Dynamics has made sure that animal owners and human patients involved in clinical trials will benefit from this new streamlined process. Tommy Jackson, COO at Prelude Dynamics states,

“VISION ePro captures real-world study data straight from the source. Built on VISION, Prelude’s world-class integrated EDC platform, this new app will enhance the experience for all parties involved in the trial process.”

VISION ePro features many of the benefits of the VISION online system in one, easy-to-use mobile application for patients and pet owners who are on the go. Features include:

  • Mobile patient-entry
  • Scheduled survey forms
  • Push notifications
  • Media-upload capabilities
  • Complete audit-trail functionality
  • eConsent capabilities

Prelude Dynamics continues to work diligently to make the clinical trial process as smooth as possible for their clients because they understand the importance of efficiency and user-friendly technology in the data-capture and data-management industries.