No Seeds…Yes, Famine
Part 5 of a 12 part series where Edward Johnson Jr. (a.k.a. Eddie) sits down with Sandra Nordahl, President, Society of Research Administrators International (SRA), to discuss the mission of…
Tags: CT
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…
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…
Regulatory Documentation in Clinical Trials
A clinical trial is only as good as the records kept by investigators and their research teams. Research sponsors tend to be very specific in outlining their expectations for records…
Public Comment Sought on Proposed Changes to Research Regulations
The U.S. Department of Health and Human Subjects (HHS) recently issued a press release outlining proposed changes to the “Common Rule”, which has gone essentially unrevised since its adoption in…