The Cost-Benefit Analysis of Engaging Statistical Experts Incorporating a statistical expert into a product development team is a strategic investment that brings immense value. It
STAT ONE: EFFECTIVE COLLABORATION FOR FDA APPROVAL Stat One is a specialty Contract Research Organization (CRO) providing expert statistical consulting, production programming, and data management
CDRH Launches the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot The FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch
FDA Guidance Adjusting for Covariates in Randomized Clinical Trials The importance of a strong statistical analysis continues to be a crucial part of drug and
FDA Guidance News To manage tracking of submissions that include real-world data (RWD) and real-world evidence (RWE), the FDA has released a final guidance asking
CEO: George DeMuth, Statistical Expert George began his career as a statistician at Burroughs Welcome and went on to start a successful statistical consulting and
Understanding FDA Study Data Standards The U.S. Food and Drug Administration (FDA) has study data standards that provide a consistent general framework for organizing study
COVID-19: Factors Affecting Conduct of Clinical Trials As clinical programs face challenges following the pandemic, companies have continued to adapt to the impact. Hurdles have
FDA releases Artificial Intelligence Action Plan Overview As the healthcare industry continues to transform through innovative technologies in the Artificial Intelligence space, the U.S. Food
