Nextrials Meets with CDER Healthcare IT Group
At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting.
At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting. Using its electronic health record (EHR) integration tool, E2E™, Nextrials staged a live demonstration for the Center for Drug Evaluation and Research (CDER) Healthcare IT Group and authors of the FDA's eSource Guidance.
This demonstration enabled attendees to examine how the integration of electronic data collection (EDC) in clinical trials with individual patient EHRs could not only provide benefits from a regulatory perspective, but also could boost patient care from the standpoint of healthcare providers. Nextrials also met with authors of the FDA eSource Guidance. The eSource Guidance provides recommendations for the use of electronic source data in FDA-regulated clinical investigations. The application of this guidance was discussed from the perspective of sponsors, patients, e-clinical software vendors and treating physicians.
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.
