The agreement signed with the US Food and Drug Administration (FDA) will see Spaulding, an early-stage contract research organization (CRO), conduct a number of clinical trials assigned by the regulatory agency’s division of Applied Regulatory Science.
Under the agreement, Spaulding will be responsible for running the trials including providing the required support services, such as clinical trial recruitment, conduct, and laboratory assessments.
The trials will examine drug product candidates in ‘various therapeutic areas of interest’, with the company stating that “all [trials] address important regulatory science questions in today’s pharmaceutical market.”
Per the financial terms of the agreement, Spaulding will receive from the FDA $5m (€4.5m) for the first out of the five years covered in the contract, to conduct the trials at its 200-bed facility in the state of Wisconsin.
The agreement with the regulatory agency follows Spaulding’s previous collaborative work with the FDA on clinical trials, which began seven years ago. The aim of that partnership had as an aim the development of a screening model for prolongation of quality testing for new drug products.
This work as well as the publications that it resulted in, helped the company build a ‘productive partnership’ with the governmental agency, said Jay Mason, Spaulding’s chief medical officer.
The signing of the contract with the FDA comes only one month after Randy Spaulding, the company’s founder, stepped down from the role of the CEO to be succeeded by the as-yet COO, Cassandra Erato.
Commenting on the projected work, Erato said that the company is ‘perfectly suited’ to conduct these trials, since it holds the ‘right-sized’ project management and principal investigator team to achieve the requested goals.
