Information Library
Results for: Clinical Services - Phase I/IIa - ECG
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Establishment and Operation of Clinical Endpoint Committees
White Paper — February 29, 2012
This white paper provides a detailed account of the operation of Clinical Endpoint Committees. It discusses how they are formed, how information is sent to -
Centralised Endpoint Adjudication in Cardiovascular Outcome Studies
Hear from the Experts — February 29, 2012
This paper provides a succinct overview of Clinical Endpoint Committees, their role in the independent adjudication of suspected cardiovascular events during clinical trials, and the need for their employment in clinical development programs for new antidiabetic drugs for Type 2 Diabetes Mellitus. -
Cardiovascular Safety Watch - Part 2: Regulatory Landscape for Off-Target Blood Pressure Assessment
Hear from the Experts — February 29, 2012
This column provides further discussion related to a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, based on feedback from additional cardiovascular safety conferences. -
Cardiovascular Safety Watch - DIA Cardiac and Cardiovascular Safety Conferences
Hear from the Experts — February 29, 2012
This column reviews the 2nd DIA Cardiac Safety Conference in Japan (held September 5th and 6th in Tokyo), and previews the 5th DIA European Cardiovascular Safety Conference, held on November 3rd and 4th in Barcelona. -
Cardiovascular Safety Watch - Regulatory Landscape for Off-Target Blood Pressure Assessment
Hear from the Experts — February 29, 2012
This column discusses a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, and the challenges of deciding which parameter(s) to focus upon, and how to determine thresholds of regulatory concern. -
Cardiovascular Safety Watch - DIA/FDA Conference on Cardiovascular Safety in Drug Development
Hear from the Experts — February 29, 2012
This column provides a report of the DIA/FDA conference entitled “Cardiovascular Safety in Drug Development: State-of-the-Art Assessments,” held in Washington DC on 14-15th April 2011. -
Cardiovascular Safety Watch - Assessments for New Oncologic Agents
Hear from the Experts — February 29, 2012
This column discusses cardiovascular safety assessments for new oncologic agents, and illustrates how benefit-risk balances differ in different circumstances. -
Cardiovascular Safety Watch - Introduction to Cardiac Safety Research Consortium
Hear from the Experts — February 29, 2012
This column provides an introduction to the Cardiac Safety Research Consortium (CSRC) and a review of its 2010 Annual Meeting and accompanying Pediatric Drug and Devices Cardiovascular Safety Think Tank, in December 2010 at the FDA Headquarters (Silver Spring, Maryland). -
Cardiac Safety Solutions
Brochure — January 17, 2012
Learn how you can proactively assess and manage cardiac safety issues for your entire product development process with the help of our cardiovascular experts and core ECG laboratory providing validated methodology, sophisticated technology and reliable data. -
The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio
Hear from the Experts — January 16, 2012
This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies.
