News By: Emily Norris

To comply with the 21st Century Cures Act,1 the U.S. Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to federal regulations. These two NPRMs are intended to harmonize the FDA institutional review board (IRB) and informed consent regulations with the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to the extent possible. 

While speed and efficiency are vital aspects of any study start-up, approaching the process with only these goals in mind can create issues that can set you back and impact the overall success of your studies. Fortunately, evaluating some of the details underlying your start-up timelines can remove the potential for certain missteps. With these things in mind, here are five tips for improving your site’s study start-up timelines.

Lessons learned from a new clinical research internship program held in central Pennsylvania last summer have helped prepare new and upcoming entrants for the research workforce, as well as to inform how the next generation of the program will evolve.

With the recent launch of the U.S. Food and Drug Administration’s Rare Disease Endpoint Advancement Pilot Program, the clinical research enterprise gains new support for efforts aimed at efficacy endpoint (or clinical outcome) development and the timely approval of drugs and biological products that treat rare diseases, including rare diseases in children.

In recognition of National Hispanic Heritage Month and the importance of clear communications between study teams and participants in clinical trials, no matter what their native languages may be, ACRP reached out to Emi Pell, Head of Sales and Marketing (Global) at Conversis, and Cassandra Andrade, Director of Strategic Accounts - Trial Interactive at TransPerfect and Brand Ambassador for Latinos in Clinical Research, to discuss careers and challenges related to translating study documents for patients.