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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.