Understand the numbers that matter to your business
We don’t just calculate statistics, we understand them. We can support your technical experts, or provide an independent review of your approach and methods. We have supported clients in all phases of development: R&D, transfer to manufacturing, clinical, manufacturing, and post-market.
- Optimized study designs
- Accurate data analysis
- Predictive modeling and simulations
Case studies
Nobody likes to be the source of the problem, but sometimes you are
The design, manufacturing, and testing teams were all blaming each other for the delay in validating the new production line. We helped everyone focus on the critical tasks to achieve an on-time launch six months later.
No validation extends outside the tested range
A client had variation between suppliers that was not well managed. We helped identify the root cause and recommended both short-term (current year) and long-term solutions.
Process simplification isn’t always simple
A client knew their current process would not pass FDA review. We fixed the process to allow removal of the single tricky step causing the concern.