PAREXEL Opens North American Facilities in PA
PAREXEL recently opened a state-of-the-art North American Coordination Hub and Distribution Center in Pennsylvania-marking an expanded presence in the region. The facility, located in Quakertown, will provide customers around the world with clinical trial supplies and logistics services designed to reduce study start-up planning and accelerate first patient-in. The North American Coordination Hub and Distribution Center can:
- Provide-local and/or central sourcing of comparator and non-investigational medicinal products
- Coordinate investigational medicinal products manufacturing through contract manufacturing organization or sponsor-delegated partners to optimize material utilization, supply and re-supply strategies, expiration dates and costs
- Offer full-service and secondary clinical packaging for randomized, double-blind or two/three panel studies, as well as customized packaging design, custom secondary packaging and patient supply kits
- Develop, translate and distribute all the documentation for sites, investigators or patients
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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
