In today’s global regulatory climate, dealing with the volume of adverse event information, accurately producing medical analysis, and maintaining timely reporting to regulatory bodies is significantly stressing many pharmaceutical medical organizations.

Our Experience

For several years, Praxis has been working with pharmacovigilance teams to help them meet today's challenges.   Our experience includes:

• Strategy development to move from paper-based processes to fully electronic distribution
• Process improvement - case processes
• Process improvement - safety letter processing
• Surveillance process design
• Planning and implementing systems related to case processes using ARGUS, ARISg, Phase Forward and Semantix
• Computer system validation for pharmacovigilance systems

Our Approach

First we make sure there is a good process foundation and that systems are appropriate and effectively aligned with the business process.  Implementing new technologies with the wrong processes  can bring your operations to a halt.

We plan these projects using our proprietary Risk-Based Planning® workshops which provide realistic, risk-adjusted schedules for these critical projects.

Overall, our approach is characterized as "partnering and collaborative" approach where our clients can benefit from our experience.