Webinars

June 13, 2013 - 11:00am (EDT)

New Strategies to Expedite Go/No Go Decisions in Oncology Trials

Ronald L Van Heertum, MD will speak on the benefits of utilizing molecular imaging in early phase oncology clinical trials and how the use of FDG PET and other molecular imaging modalities can expedite critical go/no go decisions

December 31, 2015 - 12:00pm (EST)

Clinical Research Standards and Guidances: Implications for eClinical Technology

The complexity involved in the design and implementation of clinical research technology can be daunting. There are many factors to consider in assuring the correct data is captured to determine a successful outcome, and assuring that information is collected according to certain regulatory guidelines. In addition, the study must be designed using data standards to ensure optimal submission to the regulatory agency. These data standards are vital to improving the way clinical trial information is managed, interpreted, and shared.
Modern Randomization: A Sampling of Current Schemes using IRTs

Patient randomization is critical to running all blinded clinical trials, but not all randomization methods can meet the needs of modern studies. Complex protocols that include multiple treatment arms, adaptive designs, and inconsistent allocation ratios require advanced interactive response technology (IRT) randomization engines for proper trial execution. This increased statistical power brings with it a higher risk of error and can impact drug supply predictability, making it more important than ever to find the right IRT system for your trial.
Keeping Current with Coding – The Upversioning Approach

Keeping up with medical coding standards is an important part of ensuring clean clinical trial data. This webinar will cover reasons and strategies for upgrading both MedDRA and WHODrug dictionary coding. We will discuss both internal and external tools to assist with the recoding of medical data, including the BioClinica Autoencoder Dictionary Migration (available in Express 5.2) and the MVAT (MedDRA Version Analysis Tool).
Being OnPoint with SharePoint

This webinar will explore the origins and current trends towards Clinical Trial Management Systems (CTMS) in an effort to help participants make more informed technology choices. While any good CTMS is a significant improvement over paper-based processes, the right selection will provide the automation needed to streamline trial logistics as well as help your organization save time and money.
The Capabilities of SharePoint for Clinical Trial Operations

Les Jordan, CTO, Life Sciences Industry Unit at Microsoft, will explain how SharePoint helps companies to manage their clinical operational data, to collect more timely information, and to make more informed decisions.
The New FDA Draft Guidances – What it means to me as a Site, a CRA and a Data Manager

The FDA has recently issued draft guidances for Industry on Standards for Clinical eSource and Risk-Based Approaches to monitoring which have a broad impact on almost all facets of the clinical trial management. This webinar series will discuss the impact of recent FDA guidances on industry and approaches to prepare to implement new strategies.
Independent Review for Imaging-Based Clinical Trials

Independent review of medical images is one of the most important steps in an imaging-based clinical trial. Imaging Core Labs exist to meet the demand for radiological reads as well as facilitating the acquisition and processing. For many of the processes employed there has been minimal documentation in the scientific literature to support the methodologies. This webinar will present read methodology and design as part of the detailing of the clinical trials.