Proxima Clinical Research, Inc. Participates in FDA Sponsored Pediatric Medical Device ConsortiumView All articles
HOUSTON– (September 6, 2018) – The Southwest National Pediatric Device Consortium (SWPDC), anchored by Texas Children’s Hospital and Baylor College of Medicine, recently received a prestigious P50 grant from the U.S. Food & Drug Administration (FDA). The five-year, $6.75M grant began on Sept. 1. Proxima Clinical Research, Inc. is honored to be a part of this consortium.
The SWPDC supports pediatric device innovators with the goal of addressing the shortage of novel medical devices for children, a public health problem that has been acknowledged by the FDA. “A great need currently exists for medical devices designed specifically for children,” said Dr. Chester Koh, MD founder of SWPDC and lead principal investigator. “Proxima is a valuable part of our consortium and will advise participating companies on regulatory and clinical strategies as well as support the administration process of the consortium,” he explained.
The SWPDC grant will provide services in several areas: unmet needs assessment, prototype development, product and technology acceleration services, and business acceleration services. The SWPDC members will evaluate and support projects, as well as advise innovators throughout the total product life cycle. Based on individual project needs, the consortium will direct investigators to specific resources, collaborators, and industry experts and will coordinate the services offered by its member programs to identify,evaluate, and assist pediatric device projects.
As a member in the SWPDC, Proxima Clinical Research Inc., will support and advise participating companies on regulatory and clinical strategy to advance them in their product development. “We are seeing so many exciting things happen in Houston for emerging medical device companies such as Johnson & Johnson’s Center for Device Innovation (CDI) and The Texas Medical Center’s Accelerator (TMCX),” said Jaye Thompson, PhD, co-founder and COO for Proxima. “Proxima helps emerging companies move technologies from concept to the patient. We look forward to using our experience to benefit the underserved pediatric population,” she added.
Proxima Clinical Research, Inc. is a Clinical Research Organization (CRO) serving emerging companies by providing advisory services and clinical trial solutions. For more information about Proxima Clinical Research, Inc. and the Southwest Pediatric Device Consortium,visit www.ProximaCRO.com and www.swpdc.org.