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Webinars

Webinars

Previous Webinars

APRIL 13, 2021

Implementing central reviews for Response Assessment in Neuro-Oncology (RANO) criteria: what are the specificities involved?

If you are an investigator or a sponsor involved in neuro-oncology trials, this 45-minute presentation is for you: we put the focus on RANO criteria and discuss the implementation in independent centralized reviews. These criteria have a number of specificities that can be challenging, notably:

  • RANO criteria include several criteria specific to the neurological tumor and the treatment evaluated
  • Evaluation according to RANO criteria requires a strict MRI acquisition protocol which is detailed in the Image Acquisition Guidelines provided to the investigator site.
  • RANO criteria consist of composite criteria whose clinical part participates in the definition of the response to treatment and must be accessible for the centralized assessment.

Many questions arise when speaking of RANO and this presentation is a nice opportunity for you to get a detailed overview of these criteria.

Presenters

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FEBRUARY 18, 2021

Imaging services in clinical trials: using Business Intelligence-based reporting tools to optimize operations efficiency

Efficient reporting tools are a must have when managing the vast amount of data in clinical trials. However, reports are only meaningful when they are based on accurate operational data and challenges can arise when data is constantly changing and is integrated from multiple sources using various formats.

This 45-minute presentation provides an overview on how Business Intelligence (BI) is used at Median to develop comprehensive and meaningful reporting tools based on high quality data, for better operational efficiency. Here are some insights we will be discussing:

  • BI for data management in clinical trials, including 2 main components: data integration and data visualization,
  • BI-based data integration is the most efficient way to manage clinical data coming from multiple sources using different formats,
  • BI-based data visualization enables the aggregation of data in powerful reports, providing insights on quality monitoring, activity, forecasts, and risk management for clinical trials,
  • Implementing a BI based reporting tool is an exceedingly profitable investment for both clients and imaging CROs! Let us explain why!

Presenters

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DECEMBER 3rd, 2020

Regulatory Considerations on Imaging Endpoint Procedures in Oncology Trials: a Comparison of China NMPA and FDA Guidelines

In April 2020, The China National Medical Products Administration (NMPA) regulatory agency publicly solicited opinions on the draft guidelines on “Standard and Technical Guidelines for Imaging Endpoint Procedures for Clinical Trials of Anti-tumor Drugs”.

  • How the new regulations affect the endpoint selection of cancer drug approval?
  • What are the key differences compared with FDA guidelines?
  • How to select qualified imaging vendors for this activity to accelerate the drug approval in a compliant and efficient manner?

In this presentation, Dr. Yan Liu, Median’s CMO and a member of the expert panel who developed the NMPA guidelines, as well as Mr. Faisel Jobrani, Head of Median QA provide you with a clear vision based on concrete examples.

Presenters

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SEPTEMBER 24, 2020

Imaging in oncology trials: local vs. central read workflows: Let’s discuss!

Imaging is frequently used to derive the endpoints of oncology studies; hence, it is critical to provide accurate data. However, not every study is designed the same or has the same needs. What is sufficient for your study? What alternatives do you have? The improvement of data reliability that comes with central reads is costly and some decisions are difficult to make. This 30-minute presentation + 15-minute Q&A provides a review of the imaging practices for oncology trials and the elements to support this key decision.

Agenda

  • Overview
  • Local Reads: workflow, limitations
  • Central reads: possible workflows, limitations (difficulties, operational complexity)
  • Quality of reads and variability: monitoring
  • Summary: how to choose the right design

Presenters

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