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home > white papers > Spotlight on Quality in Study Startup - Oracle Health Sciences
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Oracle Health Sciences

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Spotlight on Quality in Study Startup

This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
Spotlight on Quality in Study Startup
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The Promise and Challenge of Adaptive Design in Oncology Trials

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Clinical oncology trials are more complex and time consuming than those in any other therapeutic area and failure rates are frustratingly high. Given the urgent need for new oncologic therapies, sponsors are eager to find more effective ways to conduct clinical research. Incorporating adaptive design methodologies into clinical trials can reduce costs and enhance efficiency while maintaining trial integrity. They can also reduce the number of patients on placebo and sub-therapeutic doses. In light of this promise, regulatory bodies have created guidelines supportive of adaptive design.
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