Applied Clinical Trials Online Blog
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Applied Clinical Trials is the authoritative resource for information on Phase I - III clinical trials, news, company info, best practices, articles. Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
Applied Clinical Trials Online Blog
10h ago
The Tufts Center for the Study of Drug Development is gathering new benchmark data on the vendor qualification process including the time, cost, and resources required to qualify contract service and technology vendors ..read more
Applied Clinical Trials Online Blog
10h ago
Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease ..read more
Applied Clinical Trials Online Blog
15h ago
In part 1 of this video interview series with Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints, Getz touches on the findings from a recent study on RBQM adoption ..read more
Applied Clinical Trials Online Blog
1d ago
A survey conducted at this year’s Pistoia Alliance conference determined that although 70% of life sciences experts acknowledge artificial intelligence’s potential, many still struggle with its initiation and implementation ..read more
Applied Clinical Trials Online Blog
1d ago
A cohort study used county-level data on social determinants of health to examine their association with oncology study access ..read more
Applied Clinical Trials Online Blog
1d ago
Findings from the Phase III KEYNOTE-B21 trial show that Keytruda (pembrolizumab) plus chemotherapy as adjuvant therapy, with or without radiotherapy, administered to patients with newly diagnosed high-risk endometrial cancer following surgery with curative intent did not achieve superiority in disease-free survival over placebo ..read more
Applied Clinical Trials Online Blog
1d ago
In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare ..read more
FDA Grants Breakthrough Device Designation for At-Home Self-Collect Cervical Cancer Screening Device
Applied Clinical Trials Online Blog
2d ago
Midpoint clinical trial data for Teal Health’s Teal Wand is promising after exceeding initial enrollment numbers in the last 6 months ..read more
Applied Clinical Trials Online Blog
2d ago
Multicentric studies on diarrhea are essential for comprehending its epidemiology, causes, and treatment outcomes ..read more
Applied Clinical Trials Online Blog
2d ago
Cell-selective, adeno-associated virus gene therapy DB-OTO restored hearing to normal levels within 24 weeks in a child born with profound genetic deafness due to variants of the otoferlin gene ..read more