Quality

Processes

VirtualScopics built its strong scientific reputation in early phase studies, but our focus on operational platforms has led our customers to increasingly select us as their preferred imaging provider for late phase trials. Our adherence to the methodologies of Lean Six Sigma have allowed us to be more flexible, efficient and readily scalable to manage any size project with a proven track record of delivering accurate and on-time deliveries.

VirtualScopics utilizes Lean Six Sigma methodologies as corporate methodology to:

  • Enable rapid response to changing customer requirements
  • Provide real-time organizational visibility and focus to actions and follow-up
  • Enable surge capacity when needed for changing client priorities
  • Utilize value stream mapping approach as it is systematic and repeatable
  • Instill Kaizen philosophy for rapid implementation
  • Track and monitor performance metrics as confirmation of progress
  • Ensure mistake-proof and fail-safe operations
  • Scale operations to minimize hand offs and bottlenecks

Our regulatory-compliant environment includes comprehensive quality procedures and methods to ensure that the best possible data is collected and the analysis is performed accurately and with better reproducibility. All work is documented per GCP requirements, ensuring complete auditability for FDA-facing studies.

Phantoms

One of the great challenges of multi-site trials, especially large phase 3 studies, is ensuring consistency, reliability and harmonization among the imaging sites. To achieve these important goals VirtualScopics institutes the use of phantoms - objects used to test both scanner calibration and personnel capabilities. We will determine the type of phantom to be tested based upon the specific modality and procedure to be studied. These are shipped to the sites with specific directions for scanning and transferring of images. Our team will analyze the phantom scans, document the findings and communicate next steps.

We use phantoms in 3 specific areas of the trial:

  • Qualification - For some studies we will require sites to scan phantoms during the qualification process to demonstrate their system and overall site capabilities.
  • Training - Quite often the protocols used in a study are not commonly used in a clinical setting and are therefore likely to be unfamiliar to the site personnel. This is especially true in trials involving DCE-MRI. For this reason we will implement phantoms into our on-site training program so a complete test run can be performed on the site magnet. This will allow us to familiarize the staff with the protocol and conduct proper calibration of the equipment, if necessary. Examples of commonly used phantom designs will test field homogeneity and linearity, assess the relationship between signal and T1 and signal-to-noise ratio and contrast assessment.
  • Site Monitoring - It is critical to continuously monitor image quality and adherence to study protocol. Along with regular monitoring of patient scans, we recommend re-scanning of qualification phantoms on a quarterly basis, at a minimum. A simple quality check of this phantom data will go a long way toward minimizing the risk of flawed patient data due to system drift, field inhomogeneity or other issues.
© VirtualScopics 2013