Blog
Gretchen Bowker, Pearl IRB COO to speak at MAGI’s Clinical Research Conference in Boston, May 5-8
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...
Final Rule requires CMOs, GPOs to report annual payments to doctors
A final rule published by the Centers for Medicare and Medicaid Services (CMS) requires drug manufactures, including contract manufacturing organizations (CMOs) and group purchasing organizations (GPOs) to report annual payments to physicians or investment interests...
Hastings Center Special Report calls for changes in ethical oversight of medical research
Two articles in the Hastings Center Report, entitled “Ethical Oversight of Learning Health Care Systems” challenge the current ethical practices for protecting human volunteers in medical studies, according to a recent article on medicalnewstoday.com. The Hastings...
Mega-Trials: the new norm?
Numerous pharmaceuticals are approved and marketed based on the premise that they favorably change disease state-biomarkers. However, recent data has shown that altering the biomarkers indicative of disease does not necessarily translate to ameliorated health. In an...
Research organizations question FDA draft guidance on IRBs
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is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...