There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.
TransCelerate recently announced a new initiative focused on eLabeling in clinical trials. The eLabels Initiative is expected to improve label usage for patients, streamline labeling approaches at sites and create opportunities to decrease timelines in the investigational supply chain resulting in cost efficiencies for sponsors.
While some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.
Do 50% of US investigators only conduct one clinical trial? Much of the misunderstanding behind this “one time” claim, which first surfaced in the 1990s, rests on a misunderstanding of the BMIS.
Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.
By 2020, orphan drug sales are expected to make up 19% of prescription drug sales, excluding generics.
The emergence of risk-based monitoring (RbM) is creating a revolution in the way biopharmaceutical sponsors and CROs manage clinical trial quality.
Palatin Technologies is a biotech company focused on developing targeted, receptor-specific, peptide therapeutics for the treatment of diseases with significant, unmet medical needs and commercial potential.
With a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding.
As acceptance for risk-based monitoring grows, this e-Book examines next steps for sponsors and CROs. This e-Book offers case studies, practical tips, and applications to enhance the effectiveness of a risk-based monitoring strategy.
This e-Book features information from a recent conference of global thought-leaders in clinical data disclosure and transparency, which address current practices, potential challenges and solutions for pharmaceutical companies complying with the regulatory, ethical and legal issues around clinical trial data sharing.