BRANY Announces 5-Year Accreditation
BRANY has successfully continued its Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
BRANY has successfully continued its Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). AAHRPP’s accreditation process help organizations consistently meet ethical principles and standards for protecting research participants. This is the third time the organization has earned the five-year accreditation, meaning that for 15 years, BRANY IRB and IBC Services has met and exceeded regulatory compliance standards while focusing on strengthening protections for study participants.
Read the full release here.
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
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.
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
July 22nd 2025The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.
