WEST BEND, Wis.—Spaulding Clinical Research recently announced that it had been awarded a five-year contract with the U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science to conduct multiple clinical trials in various therapeutic areas of interest.
The deal will kick off with $5 million of clinical trial work to be run in 2020. Spaulding Clinical is responsible for conducting the trials and providing the necessary support services, including clinical trial recruitment, conduct and laboratory assessments.
“We are happy to partner with the FDA to help address agency questions about various classes of drugs. Spaulding Clinical is perfectly suited to conduct these trials, as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need,” said Cassandra Erato, CEO of Spaulding Clinical Research.
Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years.
“We began conducting clinical trials for the FDA to explore a model to screen new drugs for prolongation of QT. Through this work and resulting publications, we have developed a productive partnership,” commented Dr. Jay Mason, chief medical officer at Spaulding.
Spaulding opened in 2008 and was built upon fully electronic data and integrated, purposefully engineered systems for conducting Phase 1 trials. Spaulding runs a 200-bed facility in Wisconsin and conducts and analyzes first-in-human, clinical proof-of-concept, cardiovascular safety and NDA-enabling clinical pharmacology studies. Spaulding Clinical also provides expertise on study design, medical writing, clinical data management, biostatistics and pharmacokinetic/pharmacodynamic analysis.
