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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.