How Spaulding Clinical Accelerated PK Analysis with Aplos NCA

In early-phase drug development, speed and accuracy are everything. Since 2007, Spaulding Clinical has built its reputation as a full-service Phase I clinical pharmacology unit that delivers both speed and quality. To keep sponsors ahead of the curve, Spaulding continually invests in operational efficiency and cutting-edge technologies that accelerate decision-making while maintaining regulatory rigor.

Sponsors depend on timely PK (pharmacokinetic) NCA results to make rapid go/no-go decisions on dose escalation and study design. Traditional non-compartmental analysis (NCA) tools like WinNonlin often meant PK turnaround of 2–3 weeks,  too slow under today’s accelerated timelines.

The Challenge: Speed Without Compromise

Spaulding needed a solution that could reduce turnaround time for NCA results without sacrificing data quality or regulatory compliance. As Brian Thornton, Senior VP of Biometrics at Spaulding Clinical, put it: 

“We needed to find a way to do the PK analysis that was faster and less expensive than using WinNonlin.”

The Solution: Aplos NCA

Spaulding turned to Aplos NCA, to streamline the entire NCA workflow, from setup and calculation to export. With intuitive workflows and built-in automation, Aplos helped Spaulding streamline setup, execution, and SAS exports, eliminating manual steps and reducing the risk of error. With an intuitive interface and built-in automation, Aplos requires no specialized coding skills or lengthy onboarding.

Real-World Impact: Faster, Simpler, Smarter

Spaulding Clinical used Aplos NCA across multiple Phase I studies. The platform simplified setup, executed calculations, and exported results directly into SAS for final TLF generation. The results were transformative:

• Workflow time reduced by up to 66%: What once took 2-3 weeks was completed in just 1 week.
• Sponsor deadlines met with ease: Aplos enabled Spaulding to deliver PK NCA results quickly after concentration data became available.
• Operational efficiency improved: Automated calculations, rule-based logic, and built-in export tools eliminated manual steps and reduced errors.

“Setting up the analysis, performing the actual analysis, and exporting the information to SAS, it was all significantly faster. Aplos is very simple and easy to use. We were up and running in a few days.”
— Brian Thornton, Senior VP Biometrics

User Experience: Designed for Scientists

Unlike legacy tools, Aplos NCA was built for scientists, not programmers. Spaulding highlighted several key advantages:

• Fast onboarding: The team was fully operational within days.
• Intuitive interface: Everything from study setup to export was handled in a clean, browser-based environment.
• Automation of redundant tasks: Concentration-unit conversions, rule enforcement, and formatting were all automated.
• Consistency across users: Standard logic and formatting eliminated variability and improved quality control.

Summary: A Strategic Advantage

By adopting Aplos NCA, Spaulding Clinical achieved:

• Up to 66% reduction in PK turnaround time
• Rapid onboardingwith minimal training
• Improved responsivenessto sponsor demands
• Streamlined export to SAS, reducing internal workload

Read more here: USE CASE