The work, which involved a refit of the second floor of Spaulding’s Wisconsin, US facility, increased capacity to 96 beds making the firm the largest provider of Montara Surveyor telemetry capability in the “clinical research world.”
Company spokeswoman Amanda Baltz said that pharmaceutical industry demand for efficiency in Thorough QT (TQT) monitoring trials has increased markedly in recent years.
Baltz told Outsourcing-pharma that such trials “are typically one of the most costly Phase I studies that Sponsors conduct, and therefore, there is little tolerance for issues related to quality or execution.”
These factors, she explained, were the primary motivations for the both the new expansion and an ongoing construction project that will “increase [Spaulding’s] capacity to over 150 beds in the very near future.”
Centralisation
Baltz also suggested that the ability to conduct large cohort early-phase work under one roof fits with the current opinion among regulators worldwide on the benefits provided by centralization.
“The concept of centralized services removes so much variability within the cardiac measures and results themselves, and allows the study physicians and the Sponsors better insight into the effects of the drugs.”
This belief is in keeping with the trends highlighted by other centralised electrocardiogram (ECG) service providers in recent months, including rivals like Celerion, Clinlabs and ERT.
Data management
The Phase I expansion was also a motivation for Spaulding’s recently announced adoption of Medidata’s remote access Rave electronic data capture (EDC) platform.
Baltz explained that: “Data capture points are electronically fed into our EDC System which also allows for Sponsors to view near real-time access to all study data.