Clinipace Brings Strategic Level of Global Regulatory and Development Experience to Novel Therapy Trial
MORRISVILLE, N.C. (Business Wire) April 1, 2014 – Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today that Nexstim, a leader in navigated stimulation of the brain, has selected the company to manage the US-based clinical trial for its Navigated Brain Therapy (NBT) System.
Based in Helsinki, Finland, Nexstim develops and markets Navigated Brain Stimulation (NBS) Systems for use in diagnostics and pre-surgical mapping. In 2012, Nexstim launched a novel NBT device for the treatment of brain injury and disease using repetitive transcranial magnetic stimulation (rTMS) guided by a patient’s own MRI scan. While initial results show great promise in helping stroke patients regain lost motor control, the NBT System also enables personalized non-drug treatment for people suffering from major depressive disorder (clinical depression). The NBT System and therapeutic use for stroke and depression are not cleared indications in the US.
The NBT System meets the requirements of the European Medical Devices Directive (MDD) and has been CE marked accordingly. Nexstim’s non-invasive NBT System is not yet approved by the Food and Drug Administration for therapy in commercial use in the United States and is available to select physicians for investigational use only.
“Building a strategic partnership with a CRO with proven global expertise managing regulatory submissions and approvals is critical to the success of our US-based trial,” noted Rainer Harjunpää, Vice President, Quality Assurance and Regulatory Affairs. “Clinipace brings the right balance of regulatory and strategic development experience, working with global regulatory agencies to ensure we are compliant based on regional standards of care, standards of diagnosis, and other factors such as global marketing approval processes.”
“Clearly, new treatments such as Nexstim’s NBT System are urgently needed; however, the development of novel therapies has been traditionally hindered by challenges in conducting clinical research,” commented Jeff Williams, CEO, Clinipace Worldwide. “Our TEMPOTM eClinical platform helps investigators make faster, better informed decisions. This technology-amplified approach to clinical research helps clients like Nexstim speed and facilitates start-up of study sites, patient accrual, clinical monitoring, site management, all the way through study close-out.”
Founded in 2000, Finland-based Nexstim is the world leader in image-guided transcranial magnetic stimulation (TMS). The Nexstim NBS System is the first and only FDA-cleared and CE-marked integrated navigated TMS (nTMS) mapping device. Adjunct to physiotherapy in stroke rehabilitation, Nexstim´s Navigated Brain Therapy (NBT) System enables personalized, non-drug treatment of brain injury and disease using accurate and repeatable 3D-guidance of the therapeutic electric field. Nexstim’s NBT System is currently not available for commercial distribution in the US. www.nexstim.com.
About Clinipace Worldwide
As a global full-service digital contract research organization (dCRO), we have pioneered an innovative technology-amplified CRO service model to serve the unique needs of venture-backed, mid-tier, and strategic pharmaceutical, biotechnology, and medical device firms. Powered by TEMPO™, our proprietary eClinical platform, our team of experts brings extensive therapeutic knowledge and insight into assisting life science firms in developing and executing regulatory strategies, clinical development, and post-approval research to ensure a successful drug and medical device development program. We have managed over 1,500 global clinical research studies and completed over 300 regulatory and strategic development engagements in therapeutic areas such as cardiovascular & metabolic diseases, central nervous system, dermatology, gastroenterology, immunology, infectious diseases, nephrology, oncology, respiratory, rheumatology, and vaccines (and other cell and tissue based therapies). Clinipace Worldwide has 20 offices in 15 countries; and is headquartered in Research Triangle Park, North Carolina with additional domestic operations in Irvine, CA, Boulder, CO, and Overland Park, KS; European operations in Zurich, Switzerland, Munich, Germany, and London, United Kingdom; Asian operations in Taipei, Taiwan, China offices in Beijing, Shanghai, and Guangzhou, Seoul, South Korea, Hong Kong, Hanoi, Vietnam, Singapore, and Kuala Lumpur, Malaysia; South American operations based in Sao Paulo, Brazil and Buenos Aires, Argentina,; Middle Eastern operations in Tel-Aviv, Israel; and Indian operations in Trivandrum Kerala. For more information, visit our website at www.clinipace.com.