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Therapy & Theranostics

Delivering First Time Quality in Clinical Trial Imaging

Delivering First Time Quality in Clinical Trial Imaging

In this blog, Martin Preis, Vice President of Quality, shares how Perceptive Imaging ensures high quality in every study we support.

 

 

What is the driving force behind Perceptive’s approach to quality?

Perceptive Imaging has defined its purpose as ‘Serving science to improve people’s lives.’ As such, we consider the rights, safety, and well-being of trial participants to be the most important aspect of quality criteria in our service delivery.

How exactly does Perceptive instill quality principles throughout the delivery of imaging services?

At Perceptive Imaging, quality control and quality assurance form an inherent part of our policies and procedures. This enables us to live up to our commitment to First Time Quality, as depicted in the image below (click to enlarge).

By following these well-defined processes, we enable quality by design with clearly defined preventative and detective controls, including:

  • Automated image tracking
  • Built-in measurement assurance
  • Scientific reviews
  • Data quality evaluations.

Have regulatory agencies ever inspected Perceptive’s processes?

Yes! At Perceptive, we not only expect regulatory agency inspections, we plan for them and are always ready. To date we have participated in:

  • 5 Perceptive on-site regulatory inspections 2024 with no observations
  • 86 site and customer inspections supported in 2024

Evidence of our approach to First Time Quality can be seen in the outcome of our customers’ important clinical development programs. In 2024, Perceptive Imaging data supported 42 regulatory approvals (313 total since 2002). These approvals were granted by various authorities including, but not limited to FDA, EMA, and NMPA.

What role do employees play in Perceptive’s commitment to quality?

Perceptive Imaging scientists and science operations teams have qualified imaging centers and sites across the globe. All Perceptive Imaging employees have a clear training plan and transcript.

They also have skills and experience that match their role. And we verify that independent reviewers have the required experience and expertise and are appropriately trained as part of trial onboarding.

What do you see as the next level of quality-driven services for Perceptive Imaging? 

Perceptive imaging has automated a variety of quality controls and we’re leveraging deterministic and self-learning AI solutions to proactively identify risks and potential concerns.

 

Reach out to better understand why Perceptive’s commitment to First Time Quality can make a difference in your clinical development program.

How Can We Help?

Reach out today and one of our solution experts will be in touch to learn about your specific needs.