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Member Companies Using the QTL Framework Report Benefits in Process Efficiencies, Compliance, and More Proactive Actions



In 2021, almost 60% of TransCelerate’s members denoted they had implemented* the “Quality Tolerance Limits (QTL) Framework.” Many members have reported examples of realized benefits to their clinical operations. Below are examples from four different member companies.

Facilitates compliance with ICH E6 R2

“The solution offers the following benefits being realized in our company: ICH E6 R2 compliance and minimizing confusion – by providing detailed QTL implementation examples, it helps ensuring consistent QTL implementation across portfolio of studies. Examples included in the solution help with the selection of relevant parameters and minimize confusion around the applicability of QTLs to various study parameters.”

Increases in efficiency, minimizes confusion and / or duplication of effort

“Example of an early sign: In a study in an acute indication, a QTL was set up for data missing for the primary endpoint. Thanks to ongoing monitoring, a QTL breach was identified early on, and remedial actions were implemented.”

Enables proactive processes to focus on what matters

“QTL processes … enable proactive rather than reactive action on key parameters when they trend towards being off control (e.g., percentage or number of patients lost to follow up).

“Issues identified as a consequence of our company’s QTLs include:

  • Site only reporting adverse events due to the study drug
  • Site with an unreported premature discontinuation due to adverse events
  • Site having a backlog of data entry.”

*Based on the “implementation status” defined within a voluntary, blinded survey of TransCelerate membership, a response of “implemented” means a solution has been fully or partially leveraged. Therefore, it allows for flexibility, and those who implemented it may not have used 100% of the solution as is.