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
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.
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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
