OpenClinica
has contracted with the
SAFE-T Consortium
, a public-private partnership of the European pharmaceutical industry, academics and small and medium enterprises working to qualify translational safety biomarkers for drug-induced kidney, liver, and vascular injury to enable quicker and safer evaluations of potential new medications in patients.
Over the next three years, SAFE-T will conduct clinical trials in several sites in Europe and Israel. It is the Consortium’s largest undertaking to date and is designed to assist the pharmaceutical industry in its quest to develop new biomarkers for the early detection of drug induced kidney, liver and vascular injuries.
“We assume that OpenClinica will help us streamline the process. If every study were viewed as a separate project as is common within large pharmaceutical companies, we would not have the resources for efficiently collecting and managing essential data,” said Nicole Schneiderhan-Marra, project manager of the NMI Natural and Medical Sciences Institute in an interview. “By using a common EDC system from OpenClinica, we will reduce efforts in mapping collective data into a common data format.”
Ben Baumann
, OpenClinica’s Director of Business Development, says OpenClinica is able to provide efficiencies by standardizing on a common technology built on open standards, and using a single deployment of that technology for the customer’s benefit.
The Consortium signed to use OpenClinica’s Enterprise solution. OpenClinica Enterprise is the commercially supported version of the OpenClinica open source technology.
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.