Statistical programming is an essential element in a clinical trial. In particular, SAS statistical programming allows the huge amounts of data collected in a clinical trial to be handled and analyzed in a more efficient way. Securing high-quality SAS programming must be part of clinical trial planning.
- $How Is Statistical Programming Used in Clinical Trials?
- $What Is SAS Statistical Programming?
- $What Are the Advantages of SAS Programming over Other Software Applications?
- $What Do SAS Programmers Do in Clinical Trials?
- $What SAS Statistical Programming Services Are Provided By CROs?
- $Sofpromed: A Trusted Partner for SAS Statistical Programming
How Is Statistical Programming Used in Clinical Trials?
Statistical programming in clinical trials is a vital component for new drug development. Within the various parts of the drug development process, clinical trials rely on statistical programming for tabulating, structuring, analyzing, and submitting clinical data.
Statistical programming enables the organization, analysis, and reporting of the vast amounts of data generated during a clinical trial through the production of tables, figures, and listings (TFLs). By using statistical programming, the efficacy and safety data of a new drug can be adequately processed, assessed, and presented to regulators.
What Is SAS Statistical Programming?
SAS (Statistical Analysis System) is a standard for data management and analytics of large volumes of data used in several different industries, including medical and life sciences. This software platform is very flexible and provides users with various means to manipulate, analyze, process, and report on data. These great capabilities have positioned SAS as a leading global standard in the clinical research sector.
For example, faster advances in medicine, such as the quick development of Covid-19 vaccines, are possible thanks to statistical programming tools like SAS, among others. Harnessing the power of machine computation, the vast amounts of data needed to ensure the safety and efficacy of a new drug can be quickly and easily organized and analyzed. This is how companies such as AstraZeneca can manage to track and analyze the outcomes of the thousands of volunteers who agreed to be participants in the clinical trial of its Covid-19 vaccine. With SAS (and similar languages), statistical programmers can organize, tabulate, analyze and display —in a variety of charts and graphs— the raw data from a clinical trial to clearly demonstrate the results.
What Are the Advantages of SAS Programming over Other Software Applications?
Platforms like SAS can handle vast amounts of data, thousands of case reports, each with multiple data points required in a clinical trial. SAS is also highly sophisticated and powerful, allowing programmers to perform data manipulation and analysis to a very fine degree and clearly display the data.
The SAS platform has been developed precisely to handle the amount of data and the degree of analysis required by medicine and modern science. Such analysis is essential not only for a thorough understanding of the results of a study but also for clearly communicating those results to pharmaceutical regulators. Much of the data submitted to the FDA every year are handled with SAS.
What Do SAS Programmers Do in Clinical Trials?
Statistical programmers write statistical analysis plans (SAPs), write and execute statistical programs, and analyze data sets according to the endpoints of the clinical trial protocol, the requirements of regulators, and the needs of sponsors. Nowadays, SAS has become a very widely used language to develop and analyze clinical data sets.
Statistical programmers can quickly resource the studies required at a particular time to keep a trial on track for approval milestones. They can also provide all programming needs, from the beginning to the end of a study, and continued monitoring, working seamlessly with a client’s staff and departments.
What SAS Statistical Programming Services Are Provided By CROs?
Many clinical research organizations (CROs) with biometrics capabilities provide SAS programming services to biotechnology and pharmaceutical companies. These services typically include:
- Derived datasets.
- Database standardization for FDA submissions.
- SDTM and ADaM (annotated CRF, specifications, datasets).
- Define.xml.
- SAS programming of tables, figures, and listings (TFLs).
- Statistical reports.
- Validation/auditing of statistical outputs.
Sofpromed: A Trusted Partner for SAS Statistical Programming
A CRO with solid SAS programming expertise can ensure that a clinical trial produces clean, structured, and high-quality data accepted by regulators.
Sofpromed is an expert biometrics CRO specialized in SAS statistical programming services. We provide first-class statistical programming support to biotech and pharmaceutical companies conducting phase I-IV clinical trials worldwide, across multiple therapeutic areas.
