Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
Join Pearl staff and clinical research professionals at the MAGI Clinical Research Conference in Boston, May 5-8, 2013. Pearl’s Gretchen Bowker will be presenting “Medical Device Regulations: How device and drug regulations and guidances differ” during the Regulatory...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
Today, the IEDC released the below press release: INDIANAPOLIS (Jan. 29, 2013) – Pearl IRB, LLC d/b/a Pearl Pathways, a life sciences product development and regulatory consultant company, announced plans today to expand its operations here, creating up to 38 new jobs...