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What To Do When A New Drug Has A QT Signal – The Use of T Wave Morphology Analysis to Supplement QT Measurement

May 1st, 2014

During clinical drug development, finding a “QT signal” – evidence that a drug lengthens the QT interval – can delay or halt a drug’s development. While it is clear that all drugs which produce Torsade de Pointes lengthen the QT interval, the converse is not true, and many drugs with a modest QT signal may have little or no proarrhythmic potential. This webinar will discuss the use of quantitative T Wave Morphology Analysis to supplement standard QT assessments. T Wave Morphology Analysis is a tool to evaluate the effect of drugs on multiple components of the T wave independent of the QT interval, and which can help distinguish between drugs which are truly proarrhythmic and those which are not.

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Optimal management of lung function data to drive successful respiratory clinical trial outcomes

April 23rd, 2014

Because the prevalence and overall importance of COPD as a health problem is increasing, clinical trials involving spirometry as a metric are becoming more common. However, due to a variety of factors, the clinical data being generated in these trials is often of insufficient quality to stand up to regulatory scrutiny. In this informative webinar, we’ll look at the elements of variability in measuring lung function as well as the ATS/ERS criteria for standardizing technique. The presenters will demonstrate a jointly developed methodology for dramatically improving lung function data collection in respiratory trials, thereby improving study outcomes. Key Learning Objectives: • The significant areas of variability in lung function testing • The impact of high data variability in respiratory studies • Benefits of centralized spirometry control • How to save $100 million from your drug development budget

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ePRO Data Collection: New Findings and Key Considerations on Administration Methods, including BYOD

February 27th, 2014

This webinar reviews the results of a recently published study conducted by the PROMIS Initiative that tested the impact of Method of Administration on certain PRO measurement characteristics. Within this context, the presenters will review the benefits and key questions that clinical trial sponsors should consider when implementing a Bring Your Own Device (BYOD) approach for ePRO data collection in pre-approval studies.

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Running Successful Trials in Emerging Regions

January 9th, 2014

The clinical development world is shrinking and running trials in emerging regions is becoming increasingly desirable and acceptable. This webinar, jointly presented by Pharm-Olam and ERT, will address the challenges most commonly faced by sponsor companies: managing patients, investigative sites, and logistics while implementing technology systems to overcome multi-cultural differences and maximize trial success.

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Respiratory Update: Minimal Clinically Important Differences in COPD and Demonstrating PROs

December 4th, 2013

Pharmaceutical companies face the daunting task of getting new respiratory products approved and launched in a crowded marketplace. Two main challenges in respiratory clinical trials are; interpreting minimal clinically important differences (MCID) and designing a patient reported instrument to demonstrate a compound’s value. Both are critical in the approval of your compound as well as in post marketing activities. To compete effectively in the respiratory market, it is critical to show the value of your product over the competition. One way to do this is to examine the effect of new products on patients using Patient Reported Outcomes (PROs). In this webinar, the presenters will examine MCIDs and different types of PROs that are available for respiratory diseases and review case studies of successful demonstrations of product value in respiratory programs.

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