Quorum Review IRB Awarded Full Reaccreditation by AAHRPP
Quorum Review IRB has been awarded full reaccreditation for another three years by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
AAHRPP accredits organizations that can demonstrate they provide participant safeguards that surpass the threshold of state and federal requirements. The accreditation program utilizes a voluntary, peer-driven review and educational model.
Through the accreditation process, organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the highest standards for research. AAHRPP’s standards exceed federal regulations by requiring organizations to address conflicts of interest, to provide community outreach and education, and to apply the same stringent protections to all research involving human participants.
Quorum Review was initially awarded full accreditation status from AAHRPP in April of 2006. Accredited organizations are required to renew their accreditation with AAHRPP every three years to demonstrate compliance with current AAHRPP criteria.
Since the last review by AAHRPP in 2006, Quorum has made several changes to its service offerings, including reviewing studies in Canada. Because of these changes, AAHRPP applied the Canadian Tri-Council Policy Statement guidelines in addition to U.S. guidelines in reviewing Quorum’s processes. Quorum is now one of only a few AAHRPP-accredited IRBs that is specifically accredited to review studies in Canada as well as the United States.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
