Being Human and Considering the Role of Human Trials
The use of an experimental drug to treat a handful of health care and ministry workers infected with the Ebola virus may have attracted more press attention than the outbreak…
Tags: Clinical Trials
NIH Clinical Center Directors Annual Report
Recently, the NIH Clinical Center Directors Annual Report was released by the National Institutes of Health. The NIH Clinical Center is the “world’s largest hospital completely dedicated to clinical research”. …
Using Workflow to Manage Study Startup
InfoEd’s Clinical Trials module features highly flexible workflow administration tools that can be used to manage the various internal approvals and other steps that make up the study startup process.…
Does InfoEd Support Social-Behavioral Research (SBR)?
We’ve fielded this question during several recent product demonstrations and other interactions with prospective clients. The answer is, absolutely! The InfoEd Human Subjects module can support virtually any type of…
Handling Clinical Trial Protocol Amendments in InfoEd
According to a study by the Tufts Center for the Study of Drug Development, almost 60 percent of clinical trial protocols for new drugs are amended at least once. The…
Using InfoEd to Enhance Clinical Trial Billing Compliance
Medicare and Medicaid fraud have been in the spotlight lately, with news of the indictment of Dr. Jacques Roy and six others in an alleged scheme that cost taxpayers almost…
Form FDA 1572 Still Valid for Use
Federal agencies must periodically apply to the US Office of Management and Budget (OMB) for continued clearance of forms that collect information from the public. The process is intended to…
What’s Happening With InfoEd Clinical Trials?
The need for robust clinical trial management systems has never been greater than it is today. The changing realities of research – increasingly complex protocols, tighter timelines, and less forgiving…
FDA Warning Letters: A 2011 Retrospective
The year just ended was a busy one for the US Food and Drug Administration (FDA), particularly with regard to inspections and enforcement activities. The FDAZilla blog predicted on November…
Readability & Consent Form Development
What is readability, and why should the research community be concerned about it? Readability refers to the ease of reading and understanding written information. At this time and for the…