We are professionals proficient in designing experiments, particularly within the drug development industry. The design of experiments as it applies to clinical trials/studies is a scientific method undertaken to evaluate associations (relationships within data). Please see below for information on who we are, our values and beliefs and whom we work with.
1Who we are
M-Estimator LLC a statistical science company consisting of PhD-level statisticians with experience in all phases of clinical studies from the pharmaceutical giants to small specialty companies. Our statisticians have led global regulatory filings, developed, presented and defended positions on behalf of clients to health authorities. A premium is placed on continual learning; as a result, we publish original methodology research in peer-reviewed journals.
2Our Values and Beliefs
Our belief is that dedicated research, communication, and an innovative work ethic yields the best results for our clients. At our core is integrity. Our philosophy is that statistical science holds an objective disposition and should be indigenous within the cross-functional decision-making team. Client’s can be confident that our statisticians fundamentally understand the data and value is delivered to the cross-functional decision-making team by effectively communicating the message conveyed by that data.
3Whom we work with
Our clients come from the following fields:
- Pharmaceutical/biotech industry
- Enterprises that need expert consultation in the field of statistics and/or data science to improve the understanding of their commercial product.
FDA to sponsor
The FDA asked us to provide our plans on the handling of missing item response where the patient does not provide an answer to any or part of the daily ePRO questions. They asked us how to handle situations when the patient may be at times, too incapacitated to complete the diary.
Our support to client (sponsor):
“Our response to the FDA in part, included statistical justification around missing data. M-Estimator first made a power point presentation to our internal team on the causes of missing data, which I learned are often referred to as the mechanisms of missingness (MCAR, MAR and MNAR). Their presentation made it clear that understanding the mechanisms of missing data is important for understanding the impact of missing data and ultimately the impact on our primary endpoint. We are happy with M-Estimator’s work as they led the response on this question to the FDA.”