1 min read
ACRP | DCTs: Key Considerations for Small-to-Midsized Biotechnology and Biopharmaceutical Companies
Decentralized clinical trials (DCTs) are no fad; they are entrenched in the future of clinical development.
Byline Articles
Filter
Subscribe to Our Blog. Stay up to date with the latest news and insights.
1 min read
Applied Clinical Trials: Unraveling DCT Misconceptions
DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.
1 min read
PharmaLive: Decentralized Clinical Trials are Here to Stay
The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.
1 min read
Outsourcing-Pharma: Remarque Lands Patent for Risk-Based Quality Management Platform
The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.
1 min read
Rewriting the Rules: How to Prepare for ICH E6 (R3)
The International Council for Harmonisation (ICH) establishes industry-wide standards for clinical trials – and those standards are undergoing a complete rewrite, affecting the ways trial data is monitored, analyzed, and de-risked. These changes are being developed both at the behest of and with extensive input from a wide range of industry insiders; and they are…
1 min read
Data Literacy: The Foundation for Modern Trial Execution
Data literacy is a simple concept. Looking at data related to your area of specialty, you can deduce insights, ask appropriate questions, and make clear data-based decisions. Within the clinical trial ecosphere, each role requires a different degree of skill both vis-à-vis data in general and the trial data specifically.
1 min read
Clinical Trial Evolution: The Drive to Update ICH E6
The ICH E6 guidelines has set the clinical trial industry standard since it was first published in 1996. As clinical trials and technologies, however, continue to rapidly evolve, there is a need for these guidelines to shift as well. The industry has called for a revision of the ICH E6 (R2) guidelines to spotlight risk-based…
1 min read
How to Manage Machine Learning Algorithms in Clinical Trials
As today’s clinical trials grow increasingly complex, risk-based monitoring has become the watchword of the day. It is integral to any quality management program; it is mandated by regulatory agencies; and, critically, it is a potent tool for forestalling costly failures…