In clinical research and medical product development, biomarkers, imaging, adverse events, and statistical outputs often drive decision-making. These are all essential—but they don’t always show the full picture. They rely on indirect measures, such as lab values, imaging, and performance outcomes, to interpret what might be happening biologically at the treatment site. That’s where histology […]
Category Archives: Clinical Research
Micki Duerre (Principal Clinical Research Associate) Traceability Starts at the Source: Part 1, Navigating eCRFs, Worksheets, and eSource Why Missing Source Matters In my experience as a monitor, the fastest way to uncover hidden risks in a clinical trial is to start with the source. Source documentation tells the story the case report forms (CRFs) […]
By Micki Duerre (Principal Clinical Research Associate) In clinical research, informed consent is far more than a signature on a form – it is the foundational process that supports ethical participation and regulatory compliance. As clinical trial professionals, we understand that the consent process is not just an ethical obligation; it is a legal requirement, […]