New hospital based clinic built for efficient conduct of larger and more complex Phase I studies
Groningen, The Netherlands – QPS Holdings, LLC today announced the completion of a 24-bed annex to its Phase I clinic at the University Medical Center Groningen, bringing to 58 its bed capacity for the conduct of first-in-man and early phase research on novel and complex therapeutic agents.
The expansion was prompted by rising demand for QPS to conduct a greater diversity of the large, complex Phase I studies in which it has expertise, including: single and multiple ascending dose trials following allometric (first) dose selection to define maximum tolerated doses in first-in-man exposures; PK/PD modeling studies (e.g. model-based drug development) to define the pharmacokinetic and metabolic characteristics of new chemical entities and biologicals; 14C mass balance trials with analysis of both "hot" and "cold" species in the on-site bioanalytical and 14C radionuclide laboratories; food-effect studies, alone or combined with single ascending dose trials; BA/BE studies for formulation development, generic comparison or pivotal confirmation of a final formulation; drug-drug interaction trials; in-vitro/in-vivo comparisons (IVIVC); and Phase Ib/IIa patient studies using clinical endpoint/proof of concept in common therapeutic areas and particularly in early pharmacodynamic profiling of CNS compounds (imaging and continuous CSF sampling), respiratory agents (bronchoprovocation challenge testing), and gynecological products (transvaginal ultrasound).
"In the Netherlands, where regulatory timeframes are fast and reliable for Phase I studies, client demand is growing. For tight schedules, the Netherlands CTA approval timelines of 14 days are very attractive. Furthermore, our clinics are staffed with very experienced medical professionals who are accustomed to managing higher risk compounds and more complex clinical protocols for investigational medicinal products," said Dr. Wim Tamminga, Division Director, Clinical Pharmacology for QPS Netherlands.
"As QPS continues to expand its overall global clinical capability, we are in a great position to continue to serve our clients by moving their compounds through the drug development continuum as quickly as possible," said QPS Chief Executive Officer Ben Chien. "This additional capacity will allow our clients to benefit from conducting larger and more complex early clinical studies, leveraging the experience of our QPS Netherlands staff that has already conducted over 120 - mainly complex - early phase studies."
As a leading global provider of discovery and development services for pharmaceutical, biotechnology and medical device companies, QPS draws on innovative technologies, therapeutic expertise and a commitment to quality to help clients maximize the return on their R&D portfolios. With proven discovery through clinical development resources, the company also offers IND and NDA program partnering opportunities. QPS employs more than 900 professionals at ten sites in nine countries on four continents. In concert with its global expansion, QPS is proud of and strives to maintain a friendly and caring company culture at all of its business sites. For more information, visit www.qps.com.
About QPS
QPS is a GLP/GCP-compliant CRO that supports discovery, preclinical, and clinical drug development. We provide quality services in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, and Early Stage & Phase II - IV Clinical Research to clients worldwide. Our regional facilities and offices are located in the USA, China, Taiwan, Japan, India, Netherlands, Austria, Czech Republic, Croatia, Slovenia, Serbia, Bosnia, Hungary, Spain, Germany and the United Kingdom. Business development offices are maintained throughout the US, Europe, and Asia. For more information, please visit www.qps.com.