ACT's eNewsletter, Lab Views, brings you news specific to the laboratory and its uses in clinical trials including deals, alliances, business developments, people news, and events.
FDA Advisory Committee on Cardiovascular Safety
The FDA Endocrinology and Metabolic Drugs Advisory Committee recently voted to recommend that the FDA require pharma companies to establish cardiovascular safety evidence for new diabetes medicines. How will this impact the clinical trials industry? Joel Morganroth, MD, Chief Scientist at eResearch Technology, told Applied Clinical Trials that in the area of cardiovascular testing, "A core ECG laboratory can provide consistent and accurate evaluation of changes from baseline in 12-lead ECG morphology (such as new myocardial infarction pattern) plus identification of interval changes (e.g. QT prolongation and risk for sudden death from an arrhythmia) signals of which may be lost or be falsely positive using site interpreted ECGs. Site interpreted ECG data has so much variability and inaccuracies that core laboratory analysis, like other critical research endpoints, should always be employed."
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Enterprise-Wide LIMS for Pharma/Biotech Manufacturing
August 4, 2008
The Westin Hotel|Philadelphia, PA
5th Annual Congress: Partnering with Central Labs, Cardiology and Imaging Labs Europe
September 10-11, 2008
Courtyard Marriott Brussels|Belgium
2nd Annual Kinase Inhibitors
October 21-22, 2008
World Trade Center|Boston, MA
Maureen Loftus
- IBT Laboratories' new president and COO.
Yi Zhu
- ACR Image Metrix adds clinical research project manager.
Patrice Hugo, PhD
- MDS Pharma Services' Vice President of Scientific Affairs for its global central labs network.
Sally Warner, Medical Director, Medical Imaging Group for Perceptive Informatics, discusses "The Role of Labs in Imaging Components for Diabetes Trials" in our podcast series titled Challenges & Solutions in Diabetes. Click here to listen.
Parexel has expanded global clinical logistics for centralized coordination of clinical study supplies, lab services, and more.
Cordium Links' joint venture brings central and core lab services to China.
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Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
WCG Randomized 1,600 Participants for RSV Vaccine Trial
October 31st 2024A top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered multiple countries and contributed almost one third of overall randomizations in the supported countries, bringing the study in ahead of schedule despite delays due to COVID-19 impacts on RSV seasonality. The sponsor met study timeline past enrollment by continuing to work with WCG’s retention support.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
WCG Randomized 1,600 Participants for RSV Vaccine Trial
October 31st 2024A top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered multiple countries and contributed almost one third of overall randomizations in the supported countries, bringing the study in ahead of schedule despite delays due to COVID-19 impacts on RSV seasonality. The sponsor met study timeline past enrollment by continuing to work with WCG’s retention support.
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