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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 >

Integrating EDC & EHR for Gene Therapy in Phase 2 Diabetic Ulcer Trial

CASE STUDY April 8, 2025

Case Study: Streamlining Data Management for a Gene Therapy Trial Integrating EDC and EHR Platforms in a Phase 2 Diabetic Ulcer Study Background A biotech sponsor developing a gene therapy for wound healing in ulcerative patients needed a robust data management strategy to reconcile images from the EHR (Electronic Health Record) with their clinical database …

Integrating EDC & EHR for Gene Therapy in Phase 2 Diabetic Ulcer Trial >

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 >

Choice of Endpoint in Covid Trials

WEBINAR November 25, 2024

Presented on: September 16th at 1pm (EST) Overview: Many trials are now underway to find an effective treatment for COVID-19. To show effectiveness of a treatment a number of endpoints can be considered including duration of hospitalization, ventilator use, mortality etc. Is there a preference? Does it depend n the phase of the study? In …

Choice of Endpoint in Covid Trials >

Two-sided vs. One-sided Tests: This Should not be “Controversial”

ARTICLE November 25, 2024

The appropriateness of two-sided vs. one-sided hypothesis tests in clinical trials has been the subject of an old debate.  This is probably because of the intra and inter disciplinary disagreements among statisticians, clinicians and regulators on this matter often expressed via conflicting recommendations in the literature. First let’s look at how the current ICH E9 Guidance …

Two-sided vs. One-sided Tests: This Should not be “Controversial” >

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