Vitalograph Successfully Passes MHRA and FDA Audits
Vitalograph has passed its first routine inspection by The Medicines and Healthcare products Regulatory Agency (MHRA). The Agency reported zero critical findings, zero major findings and few observations. Vitalograph is one of 5% of CROs to pass with this degree of success.
“The results of our MHRA audit in October confirms that our systems and processes...meet the high standards of best practice demanded by this rigorous regulatory environment,” says Vitalograph Clinical Trials Director, Lewis Weidman.
Last year’s FDA audit of the Vitalograph research and manufacturing facility in Ennis, Ireland was also a great success, with zero deficiencies {483's} raised.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
