ERT, a provider of centralized services to the biopharmaceutical, medical device and related industries, announced the launch of Centralized Cardiac Safety 2.0, a portfolio of new solutions that enable a new approach to cardiac safety in clinical trials. These new solutions were developed to overcome many of the perceived barriers to centralizing all ECGs in clinical trials. ERT’s aim is to improve the science of cardiac safety while helping sponsors reduce overall costs with the adoption of a fully centralized approach.
ERT’s Centralized Cardiac Safety 2.0 strives to improve data quality, reduce the investigator workload and improve the overall user experience at the investigative site. The commercial value to sponsors and contract research organizations is derived from cost savings and more efficient operations across entire programs of drug development.
As part of the Centralized Cardiac Safety 2.0 solution, ERT has also introduced ELI-PC from Mortara Instrument. TThis small hand-held ECG collection device aims to make it easier for companies to adopt a centralized system as it interacts automatically with the central database.
Integration of this new ECG machine into computer systems will enable key information, such as patient demographics, to be automatically downloaded before a trial.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
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.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.