News & Analysis on Clinical Trial Services & Contract Research And Development
When a clinical trial requires local or point-of-care laboratory testing, managing the resulting data can be a significant burden to both the sponsor and the investigator sites. There are several factors driving the need for local lab support during...
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...
Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent of Phase III studies failed due to safety (compared to 55 percent for efficacy), down from 21...
Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and...
Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their patients to the investigator. BBK Worldwide’s Study Voices survey challenges the myth, invoking a...
In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of pharmaceutical professionals, including sponsor companies as well as contract research, development,...
The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness of the validated analytical method. In...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...