Pharmasol Launches New psiXchange Capabilities
Pharmasol has announced the availability of psiXchange version 2.4, which automates the safety document distribution process within clinical trials. PsiXchange is an automated system that establishes relationships between data from multiple sources. The new enhancements within this release include expanded site views, enabling support of clinical operations and site-based teams, and provides information in real-time to a variety of global recipients involved in the drug safety management chain.
Safety documents like suspected unexpected serious adverse reactions (SUSARs), line listings and development safety update reports (DSURs) can be sent to all recipients including sites, ECs (ethics committees), IRBs (institutional review boards), and others through Safety Central (the smart portal that is part of psiXchange). These safety documents are automatically distributed using the embedded country rules and recipients’ language preferences.
For more information, click here.
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.
