In the past few weeks, mid-size CROs Clinipace, Medpace and Rho have all won contracts to manage various clinical trials.
Clinipace was selected by Nexstim to manage a US-based clinical trial for its Navigated Brain Therapy (NBT) system. Helsinki, Finland-based Nexstim develops and markets Navigated Brain Stimulation (NBS) systems for use in diagnostics and pre-surgical mapping.
The NBT system meets the requirements of the European Medical Devices Directive and has been CE marked but it is not yet FDA approved for commercial use 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.
CRO Medpace, which was purchased by a private equity firm in February , will collaborate with NephroGenex to conduct a Phase III study of a diabetic kidney disease treatment. NephroGenex expects to launch the first of two Phase 3 trials in the first half of 2014.
NephroGenex CEO Pierre Legault said that both Medpace and the Collaborative Study Group (CSG), a nephrology academic research organization, "were instrumental in conducting our previous Phase 2b study, through which we were able to identify a Phase 3 patient population accepted by the FDA under a Special Protocol Assessment. These collaborations give NephroGenex the reach and expertise required to successfully execute the oral Pyridorin Phase 3 PIONEER program through to regulatory submission."
And finally, CRO Rho joins ClinicalRM, PPD and Technical Resources International to be selected by the US Department of Health and Human Services’ BARDA (Biomedical Advanced Research and Development Authority) for a grant to develop anti-terror treatments.
Rho will help to develop treatments that protect against bioterrorism and other public health emergencies. The award includes a minimum guarantee of $400,000 over the initial two years and may be extended for up to a total of five years and a maximum of $100m.