Standardized Metrics for Better Risk Management: The Right Data at the Right Time
August 31st 2016Just because information can be gathered and shared more quickly among stakeholders does not mean that it can identify risk. This article describes the need for pharma to adopt fully-vetted, standardized operational-level time, cost and quality performance metrics as tools for tracking and predicting performance.
Gastroparesis Treatment: What’s Coming Up Next
August 29th 2016Gastroparesis patients face a series of symptoms for which there is currently a significant void in treatment. With complications and questions aplenty, answers are in high demand as physicians search for suitable medicines to combat this disease.
Early Phase Clinical Trials in Patients With Hepatic or Renal Impairment
August 26th 2016Studies in Hepatic and Renal Impaired special populations have almost always required drugs with systematic absorption resulting in unclear conclusions. A solution for this would be a study design based on pharmokinetic properties that incorporates principles of Hepatic and Renal Impaired pathologies.
Getting There: A Behind the Scenes Look at Cancer MoonShot 2020 - ACT
August 24th 2016The Cancer Moonshot 2020 Initiative has been a long time coming for the team working to develop the program’s infrastructure and logistics. Following years of planning the result has been an increased response in the belief that a vaccine-based immunotherapy to battle cancer will be available by 2020.
Merck’s Adam Colley on TransCelerate’s SQT Initiative: Mutual Recognition for EDC System Training
August 23rd 2016TransCelerate’s Site Qualification and Training Initiative has launched a special project aimed at improving Electronic Data Capture system efficiencies between sponsors and sites. Adam Colley of Merck explains the improvements that this initiative will provide for training providers and sites.
Tribunal Orders Release of Withheld Data from London Trial
August 19th 2016The tribunal noted the "strong public interest in releasing the data given the continued academic interest" and "the seeming reluctance for Queen Mary University to engage with other academics they thought were seeking to challenge their findings."
Europe Makes Medicine Research Grants Conditional on Open Access
August 18th 2016EU Research Commissioner Carlos Moedas says all data generated under the $350 million Horizon 2020 projects will be open access. This supports the shift of greater cooperation in research and a new era of global and open science.