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The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
Investigators have temporarily halted a trial of NewLink Genetics’ experimental Ebola vaccine after several patients reported unexpected side effects. Read More
India’s Central Drugs Standard Control Organization has a released a draft document outlining accreditation and ethics standards for clinical trial sites, investigators and ethics committees. Read More
Sponsors of clinical trials comparing two or more standards of care should ensure that potential enrollees understand the pros and cons associated with each of the treatment options, HHS' Office of Human Research Protections says. Read More
India’s Central Drugs Standard Control Organization is seeking industry feedback on a draft of accreditation and ethics standards that it expects from clinical trial sites, investigators and ethics committees. Read More
The UK’s Health Research Authority is proposing a set of scaled-back procedures for obtaining informed consent from patients in simplified pragmatic research trials. Read More
The FDA is working on a number of projects designed to lower clinical trial costs and speed up trial times, a top FDA official told conference-goers at the Society for Clinical Research Sites’ 2014 Site Solutions Summit. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.
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Manufacturers of interventional cardiovascular devices may benefit from holding their first clinical trials in Europe, a clinical research organization advises. Read More
A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. Read More
A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators. Read More