Pfizer's Quality by Design Approach to Trial Management - Pharmaceutical Executive


Pfizer's Quality by Design Approach to Trial Management

Pharmaceutical Executive

Monitor and control

Finally, in order to proactively monitor the new TMF process, key quality control measures were implemented per metrics defined by the CTQ dimensions. The CTQs were rolled up into three key performance indicators: completeness, document quality, and timeliness. Control points were established at key trial milestones which provide real-time feedback on quality performance to study teams and to line management. This enables active management of quality by providing transparent line of sight into quality—when correction requires the least amount of effort. These built-in controls and management reports are used throughout the lifecycle of a study, enabling proactive and continual performance management. As a result, study teams and management have a high level of visibility in monitoring and securing overall TMF quality. This approach also drives increased accountability across the organization.

Bottom line: What was achieved

Little more than a year since the launch of the new TMF process and technology solution, Pfizer has witnessed significant improvements across all three measures of TMF health—completeness, document quality, and timeliness. In particular, TMF completeness—a measure of the presence of required TMF documents at any given point in the trial—improved by more than 50 percent and is progressing well toward meeting established TMF performance targets. More important, for the first time in Pfizer's history, the entire organization has clear visibility into the status of the TMF and is able to intervene in a timely manner to enable quality.

The application of QbD principles to clinical trial processes has provided Pfizer the unique opportunity of achieving the consistent quality demanded by regulators, while reducing operational cost and burden. Pfizer's application of QbD principles to the TMF process is a powerful example of this, and the organization is now extending this approach to other clinical trial processes, including protocol development, data management and regulatory submission management. The key outcome has been increased transparency and real-time visibility into process quality. This ability to actively monitor and control quality reduces regulatory risk, protects patient safety, and results in operational benefits that avoid costly and time-consuming rework, which ultimately increases speed to market and, more importantly, brings medicines to the patients who need them.

Ivan Walrath is TMF Process Owner, Senior Director, Development Operations at Pfizer. He can be reached at
. Coleen Glessner is Head of Clinical Trial Process and Quality, Vice President, Development Operations at Pfizer. She can be reached at
. Amy Cheung is a Senior Manager at Deloitte Consulting. She can be reached at
. Dan Ressler is Principal at Deloitte Consulting. He can be reached at


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