Spaulding Clinical Research has begun $5 million of clinical trial work as part of a five-year contract with the U.S. Food and Drug Administration.
The West Bend-based research center runs a 200-bed facility and conducts and analyzes first-in-human, clinical proof-of-concept, cardiovascular safety and NDA-enabling clinical pharmacology studies.
Spaulding Clinical’s contract includes work for an FDA department that is charged with approving all new drug applications in the U.S. Recent work of the FDA’s Division of Applied Regulatory Science has included examining drugs of abuse, including opioids; methods for evaluating new drugs; generics and biosimilars; and over-the-counter products, such as sunscreen.
“We’re really touching all of those,” said Spaulding Clinical chief executive officer Cassandra Erato. She declined to disclose specific therapeutic areas of focus.
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