At dataPharm our specialty is the application of statistical methods to the ongoing development & performance of manufacturing processes, analytical methods, and quality management systems. We also provide statistical programming and data management services for customers who are either directly engaged in or supporting clinical research through Phase I, II, and III trials.
The benefits of our statistical services are provided for our clients through our proficiency in communicating and documenting statistical approaches in a clear, understandable manner. Such communication is vital not only for making sound scientific inferences today but also to facilitate complete knowledge transfer to those in your organization who will need to leverage today’s information tomorrow. As a result, our combined statistical and communications expertise strengthens your ability to demonstrate complete satisfaction of regulatory expectations while preserving business continuity for your organization.
Our overall support of your operations is not only technical, but strategic. We understand the regulatory and business impact of making changes to existing manufacturing processes. We also understand the regulatory implications of making changes to an analytical method or replacing a method with an improved technology. This allows us to help you define the appropriate validation strategies for obtaining regulatory approval of the changes you need to implement.