Oct 31, 2016, 12:03 by Michael Croft

STAT |  If data are collected using standards that are compatible with each other, they will be more easily shared and provide the greatest return.

Oct 31, 2016, 11:35 by Michael Croft

Outsourcing-Pharma |  Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.

Oct 28, 2016, 15:03 by Michael Croft

23andMe |  23andMe and Pfizer are collaborating on a lupus trial. The two have enrolled 5,000 people with autoimmune disease, and hope to use genetic and survey data to learn more about the genetics of lupus.

Oct 28, 2016, 11:34 by Michael Croft

MassDevice |  Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.

Oct 28, 2016, 10:45 by Michael Croft

Clinical Informatics News Briefs | New partnerships and products from BBK Worldwide, Emulate, Veeva, and more.

Oct 27, 2016, 09:30 by Michael Croft

Clinical Informatics News | Typically, sharing information in the life sciences industry has proven more challenging primarily because of siloes in place between not only companies, but also functional areas within an organization. A unified clinical technology landscape can have a positive impact that ripples throughout the entire organization. 

Oct 25, 2016, 16:35 by Michael Croft

STAT |  New data indicates prescriptions for the allergy emergency device are outpacing last year's figures. Overall, the number of prescriptions for EpiPen is up 14% through September, compared with the same period in 2015. In fact, there were 40% more prescriptions written in the first nine months of this year compared with 2013, even as the price for EpiPen was rising.

Oct 25, 2016, 12:06 by Michael Croft

NEW HAVEN, CT - Oct 25, 2016 - Cogstate and Clinical Ink Deliver Enhanced Tablet-Based eCOA for CNS Clinical Trials Cognitive science company, Cogstate Ltd (ASX

Oct 24, 2016, 10:15 by Michael Croft

Clinical Informatics News Brief | Dell Technologies Enterprise Content Division (ECD) announced the general availability of EMC Documentum for Life Sciences 4.2.
The EMC Documentum for Life Sciences solution suite is designed to break down information silos to transform how organizations access, manage, and share regulated content.

Oct 24, 2016, 09:52 by Michael Croft

BOSTON, MA, USA - Oct 19, 2016 - The Pistoia Alliance, a global, not for profit alliance that works to lower barriers to innovation in life sciences R&D, has today announced that Pine Biotech and Medexprim have been selected as the grand prize winners of its 2016 President’s Startup Challenge

Oct 24, 2016, 09:21 by Michael Croft

Pharmaphorum |  The UK government has published its long-awaited Accelerated Access Review, a report that aims to cut up to four years from the process that gets a drug from the lab to use on England's National Health Service.

Oct 24, 2016, 09:06 by Michael Croft

RESEARCH TRIANGLE PARK, NC, UNITED STATES - Oct 24, 2016 - Cenduit, a joint venture between QuintilesIMS and Thermo Fisher Scientific, is participating in a free webinar hosted by QuintilesIMS, where expert guest speakers will highlight regulatory trends, technology innovation and industry perspectives surrounding Continuous Glucose Monitoring (CGM) to help sponsors develop smarter diabetes clinical trials

Oct 21, 2016, 10:34 by Michael Croft

STAT |  An FDA official said this week that Sarepta's approach in winning approval for its DMD drug should not be copied by other drug firms.

Oct 20, 2016, 13:49 by Michael Croft

Nature News & Comment |  EMA becomes first major drugs agency to publish clinical study reports online.

Oct 19, 2016, 08:29 by Michael Croft

PRINCETON, NJ, US - Oct 19, 2016 - DDi the eclinical and technology partner of pharma and Biotech companies is selected by Asia Pharma Major for Clinical Oversight and RBM

Oct 19, 2016, 08:17 by Michael Croft

PRINCETON, NJ - Oct 19, 2016 - Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that the Office of Generic Drugs (OGD), US Food and Drug Administration (FDA) has awarded it a multi-year research grant to create and validate a physiologically-based pharmacokinetic (PBPK) modeling and simulation framework that complements existing models within the Simcyp® Population-based Simulator

Oct 18, 2016, 13:59 by Michael Croft

PHILADELPHIA, PA, UNITED STATES - Oct 19, 2016 - ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today announced its support of the regulatory review of Pediapharm’s Health Canada approval of rupatadine

Oct 18, 2016, 11:05 by Michael Croft

RESEARCH TRIANGLE PARK, NC, UNITED STATES - Oct 18, 2016 - Cenduit, a joint venture between QuintilesIMS and Thermo Fisher Scientific, is showcasing its solutions and expertise as the largest interactive response technology (IRT) specialist in the world at IRT 2016 — Interactive Response Technologies in Clinical Trials, October 25-26, 2016 in Philadelphia

Oct 18, 2016, 10:35 by Michael Croft

FDA Blog | The FDA has announced a new cluster with the EMA to advance treatments for patients with rare diseases.

Oct 18, 2016, 10:20 by Michael Croft

Clinical Informatics News Brief | The FDA announced yesterday that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases.