Medidata Announces Launch of Medidata Detect
Medidata, a Dassault Systèmes company, announced the launch of Medidata Detect, a centralized statistical monitoring solution that aims to improve data quality and promote patient safety in clinical trials for new medicines, vaccines, and medical devices. Medidata Detect, part of Medidata’s regulatory-compliant and unified Medidata Rave Clinical Cloud platform, helps customers manage data quality, monitor site performance, and promote patient safety by uncovering and finding errors, trends, and anomalies in data through statistical algorithms and tests.
Glen de Vries, co-founder and co-CEO, Medidata said, “Detect is another example of our continuous innovation that helps advance clinical trials with increased data accuracy and speed. It’s another way we’re working to get important new vaccines and therapeutics to patients in safer, faster ways.”
A report in the Journal of the American Medical Society (JAMA)* found almost a quarter of new drug submissions required one or more resubmissions before they were approved, with a median delay to approval of 435 days following the first unsuccessful submission. Medidata Detect uses one central system for aggregation and review of any number of data sources, flagging data errors, trends, and anomalies in real time.
* Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE, “Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012.” JAMA.2014;311(4):378–384.
Read the full release, here.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
