Quality System

 

qPharmetra has invested significantly in its Quality System to ensure that all clients get high quality, reliable analyses, models, and reports on every project from all our consultants. Our Quality System is built upon three components: the Quality Management System, Standard Operating Procedures and Best Practices.


Quality Management System

Our Quality Management System is captured in an over-arching living document that describes what we do everyday to provide our clients with results that they can rely on to make critical decisions about their drugs. It describes our practices to implement quality control and assurance steps on each project, identify and resolve issues and make continuous improvement. Our broad quality objectives are to thoroughly document the process, so it can be recreated internally and by the client, and to make sure the analysis is correct by using a consultant who is not directly responsible for the project to review the work.


Standard Operating Procedures

We currently have over 15 SOPs that provide a consistent way for all of our consultants to execute their projects. Through our experience we know that there is the need for much creativity to provide excellent pharmacometric and clinical pharmacology consulting, however certain parts of the process need to be done in a consistent and repeatable manner to ensure the integrity of the process. The SOPs listed in the table provide a flavor of the areas we have found important to systematize. We are happy to share our full list of SOPs with you when we engage in a project.


Partial List of qPharmetra SOPs

  • Employee training
  • Deviations and Corrective Action
  • Data Handling and Storage
  • QC of Data Management
  • QC of Model Analysis
  • Report Generation
  • QC of Report
  • QA of Project


Best Practices for Rapid Company-Wide Learning

We do this work because we love to learn. We find working with new drugs and developing new models incredibly stimulating. We actively share our learning within the company, so as an organization we can learn much faster than we can individually. We don’t want each consultant to reinvent the wheel, so we have incorporated these approaches to ensure that our best practices are shared and used throughout the company:

  • Turn our learning into Standard Operating Procedures and internal software tools that everyone can use
  • Project review meetings are used to identify and discuss new analytical and modeling techniques as well as client feedback
  • A standard report framework is used to make sure each qP report contains all the information we know is critical for the client and ultimately for review by regulators
  • Consultants frequently solicit company-wide input on modeling and disease-specific information to access new ideas and approaches