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PRIM&R Webinar: Overcoming Obstacles to Research with Pregnant Women

Posted on March 13, 2013 by Matthew Tanner | 0 Comments

From PRIM&R: Overview Pregnant women have historically been excluded from participation as subjects in biomedical research, but there is increasing recognition in the research community of the importance and of the vast potential benefits to allowing their participation. This webinar…

Using Workflow to Manage Study Startup

Posted on July 10, 2012 by admin |

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. The starting point for these configurations is the creation of…

Process Change in Clinical Research

Posted on June 11, 2012 by Matthew Tanner |

The adoption of new software presents a valuable opportunity to improve internal processes and workflows. It also means asking a large number of people to change their individual work patterns, especially if they are making a transition to paperless processing…

Does InfoEd Support Social-Behavioral Research (SBR)?

Posted on May 8, 2012 by Matthew Tanner |

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 IRB review, including both biomedical and SBR models. Flexible administrative…

Handling Clinical Trial Protocol Amendments in InfoEd

Posted on April 9, 2012 by Matthew Tanner |

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 first step with any amendment is to understand what changes…

Using InfoEd to Enhance Clinical Trial Billing Compliance

Posted on March 12, 2012 by Matthew Tanner |

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 $375 million. Payments to over 75 home healthcare agencies have…

Form FDA 1572 Still Valid for Use

Posted on March 5, 2012 by Matthew Tanner |

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 ensure that forms are appropriately designed and are not unduly…

What’s Happening With InfoEd Clinical Trials?

Posted on February 10, 2012 by Matthew Tanner |

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 budgets, in a heavily regulated environment – are making continued…

Menlo Report Comments Deadline Approaching

Posted on February 10, 2012 by Matthew Tanner |

February 27, 2012, is the deadline to submit public comments on the Menlo Report outlining recommendations for the ethical conduct of information and communication technology research. Building on the framework of the Belmont Report, which promoted respect for persons, beneficence, and justice…

FDA Warning Letters: A 2011 Retrospective

Posted on January 8, 2012 by Matthew Tanner |

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 30, 2011, that the number of 483 Forms issued for…