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Estimands in Today’s Clinical Trials & Regulatory Landscape

This panel discussion discusses the role of Estimands in enhancing precision to meet study objectives and share examples of their application in specific trials and analyze case studies from the regulatory point of view. Our expert panel of medical directors, biostatisticians, and medical strategy experts address the above challenges, sharing their views on new strategies that help enhance clarity in …

Estimands in Today’s Clinical Trials & Regulatory Landscape >

Enhancing Clinical Data Quality: A Programmatic Approach for RECIST Data Checks in Oncology Studies

Objective A small oncology biotech company with an expanding pipeline required a flexible resourcing model of statistical programmers to address their immediate priorities. One crucial need was supporting database lock (DBL) and Clinical Study Report (CSR) activities for a Phase 2 solid tumor study while developing project timelines for key objectives. The Inference team prepared …

Enhancing Clinical Data Quality: A Programmatic Approach for RECIST Data Checks in Oncology Studies >

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