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Estimand Framework : Ophthalmology Trial Evaluating a Combination Therapy

CASE STUDY September 8, 2025

Background This case study applies the estimand framework from ICH E9(R1) to a clinical trial comparing the efficacy and safety of a fixed combination of two components with each component used in monotherapy for patients with bilateral ocular hypertension or open-angle glaucoma. The randomized, double-masked, multicenter trial enrolled 335 patients and assessed intraocular pressure (IOP) …

Estimand Framework : Ophthalmology Trial Evaluating a Combination Therapy >

Estimands in Today’s Clinical Trials & Regulatory Landscape

WEBINAR April 2, 2025

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

CASE STUDY March 15, 2025

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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