PSI Expands International Clinical Trial Presence to South Africa
Today, PSI CRO, a full-service contract research organization, announced their expansion into South Africa.
South Africa is a multi-cultural nation with a population of ~50 million people. It has a long history of conducting clinical trials. As such, there exists a strong infrastructure to support all needed activities including regulatory oversight and experienced researchers. Data generated from South African trials receives international acceptance. Expert opinion leaders work in South Africa, providing a high standard of medical care. Therefore, patients who have received state-of-the-art therapy, in addition to treatment-naïve patients, may be recruited for clinical trials. PSI will expand its access to all African countries from the strong base in Pretoria. PSI’s current experience in South Africa stretches across the areas of oncology, CNS, urology, diabetes and other therapeutic areas.
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 Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
