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PRA ‘toolkit’ pinpoints rare-disease clinical trial risks The free Patient-Centric Trial Development Toolkit is aimed toward helping sites and sponsors identify and minimize risks in rare-disease clinical studies. PRA Health Sciences has launched its Patient-Centric Trial Development Toolkit, a resource designed to aid clinical trial teams in identifying risks that could stymie the effectiveness and efficiency of their research, and deal with those problems. Outsourcing-Pharma recently spoke with Scott Schleibner, senior vice president of the Center for Rare Di...

IQVIA completes acquisition of Q2 Diagnostics The clinical research tech specialists, which had held 60% of Q2 Diagnostics, will now wholly own the comprehensive clinical laboratory services company. IQVIA Holdings, which provides analytics, technology solutions and clinical research services to life-science clients, has acquired the remaining 40% of Q2 Solutions from diagnostic information services provider Quest Diagnostics. The companies report that $760m changed hands in the deal, via cash on hand. Brian O’Dwyer, Q2 Solutions CEO, spoke with Outsourcing-Pharm...

Dive into advanced data, ethical issues at free online event (NatalyaBurova/iStock via Getty Images Plus) The April 6 webinar, Clinical Development Innovations, will touch upon artificial intelligence, machine learning, ethics and other impactful issues. In the face of increasingly complex data, pressures to get therapies to market as rapidly as possible, desire to decrease patient burden, COVID-19-created obstacles, and other challenges, clinical research professionals are under a great deal of pressure. Any technology or tools that empower them to accomplish thei...

FDA current COVID-19 updates, actions and advice As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance. The phenomenon of "vaccine euphoria" has taken hold in the US, with patients receiving their first or second shots gleefully sharing images on Facebook, Instagram and other social media platforms. Still, because the virus is not over, the US Food and Drug Administration (FDA) continues to act as a resource for medical professionals working on tests, treatments an...

GSK expands its clinical trial manufacturing capacity at dedicated CGT facility in UK Cell and Gene Therapy Catapult (CGT Catapult) says that GSK will leverage its Stevenage facility to perform GMP cell processing and accelerate its cell and gene therapy pipeline for clinical trials. Through this agreement, GSK is looking to improve its GMP cell processing network to advance its early stage pipeline and streamline technical transfer. “The move by a leading pharmaceutical company like GSK to establish ATMP manufacturing capabilities at the CGT Catapult facility i...