Blog
New Guidance Issued on Informed Consent Waivers for Minimal Risk Studies
The US Food and Drug Administration (FDA) on Monday, July 24 issued guidance detailing the circumstances to which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants, according...
Site Selection Tips
Kunal Sampat, MNA, senior manager for Clinical Trial Programs at Abbott Vascular believes that data should lead the way it comes to site selection. He says, “let data drive your site selection decisions” and “don’t support lousy site seletion.”1 His other tips...
Promoting Clinical Trial Participation
Doctors told T.J. Sharpe that they would be surprised if he was still alive in two years. That conversation occurred five years ago. Clinical trial practitioners helped Sharpe beat the odds. Sharpe says, “You and I can’t cure cancer, but we can help the people who...
Gretchen Bowker to lead session at 2017 RAPS Convergence
Gretchen Bowker, Co-founder and COO of Pearl IRB, will lead a session of the Health-Related Foods Track at this year’s RAPS Convergence in National Harbor, MD. The session, titled "Functional Foods and Dietary Supplements: Manufacturing, Claims, and Marketing," will...
BioCrossroads competition encourages entrepreneurial activity of Indiana life science companies
The BioCrossroads New Venture Competition, an early stage business competition designed to encourage entrepreneurial activity of Indiana life sciences and health information technologies, is now accepting applications at www.biocrossroads.com. Since 2012, the...