About StatWorks

StatWorks, Inc., founded by Suzanne Hackett, M.S., in 1997, is a growing clinical research firm that specializes in providing high quality statistical and data management services to biopharmaceutical and medical device companies.

We partner with our customers in a variety of ways. We provide the analysis and programming for individual studies. We function as the virtual statistics department for several smaller companies. We perform strategic consulting for development companies, investment groups and others in trial feasibility and design.

In addition, we assisted with a number of academic research projects and publications. Examples of our consulting services include sample size calculations, protocol design, randomization, CRF development, database design, data entry and validations, analysis troubleshooting, and regulatory interaction.

StatWorks serves a diversity of customers, including small biopharmaceutical companies with one compound as well as large multinational organizations. We assist these groups in all phases of development, from phase I to phase IV, as well as with publications and other research projects.

We have a long history of working with our sponsors in supporting regulatory filings as well. To date, we have assisted in the preparation of two NDAs, a PMA, an MAA, a Japanese submission, and a CTD filing. We have participated in FDA meetings, analytical requests, and presentations.

StatWorks is a company of talented and experienced professionals working efficiently to provide excellent service and accurate results. Through resourcefulness and flexibility, we adapt our processes to meet each individual client's needs.