Statistics is the branch of science that deals with many numbers which are generated in a controlled environment for a given process, which latter on analysis helps understanding the significance of the activity. Statistical Analysis is tedious process and demands the best concentration levels of the statisticians across the globe. A small error in computation may cause the sabotage to the entire study. Thus electronic ways of computing statistics which are accurate, reliable and made simple all together constitute Statistical Computing. This Statistical Computing has a wide range of applications in clinical trials industry
Statistical Computing in clinical trials industry is carried out in a particular regulated and controlled environment, which is referred to as Statistical Computing Environment. In Statistical Computing Environment initially a Statistical Analysis Plan is documented. Few other good areas for statistical computing include Analysis of data files, programming statistical results, generation of compiled reports, Certain Validations according to the regulatory authority guidelines and compliance, we need to publish the relevant results and enable the data view on demand.
Statistical Computing Environment needs to address few topics and concepts which are predefined to ensure the smooth transaction of the entire process. The concepts that needs to be revised for a stable Statistical Computing Environment in place is Metadata concepts, Standard data transformations, capable reporting system, professional and proficient documentation system, publishing the necessary data in compliance to the Audit trial and data security.
Statistical Computing Environment is a huge concept in making and continuously changing aimed at improving the quality and efficacy of the drug in making and bring out a renaissance in current clinical trials process