Pharmaceutical Research and Manufacturing organizations rely on STATISTICA as an integral analytics platform for drug discovery, development and quality control. StatSoft has been providing analytic solutions to the Pharmaceutical industry for over 10 years, with long term relationships with organizations spanning that entire time. Currently five out of the world's 10 largest pharmaceutical companies rely on STATISTICA products.

STATISTICA solutions are also used for validated applications. StatSoft's software development methodology and the wide range of testing performed on STATISTICA products are well-documented. Moreover, StatSoft provides a full suite of validation services to complement its products. StatSoft products have been audited and evaluated for Part 11 compliance. The entire suite of STATISTICA products are integrated with a robust, scalable Document Management System that is Part 11-compliant. The STATISTICA Document Management System stores, secures, and versions any type of electronic document including STATISTICA Spreadsheets, Graphs, Workbooks, and Reports.

Research & Development

Improvements in the time-consuming and expensive process of research and development translate directly to an organization's bottom line. Pharmaceutical research organizations have experienced the positive impact of the deployment of the STATISTICA Enterprise platform. STATISTICA is the multi-user, server-based analytics platform to empower scientists with analytical tools that are easy to use, relevant, and integrated with their data sources. The STATISTICA platform results in hard and soft return-on-investment (ROI) by:

• empowering scientists with the analytic and exploratory tools to make more sound decisions and gain greater insights from the precious data that they collect
• saving the scientists' time by integrating analytics in their core processes
• saving the statisticians' time to focus on the delivery and packaging of effective analytic tools within the STATISTICA framework
• increasing the level of collaboration across the R&D organization by sharing study results, findings, and reports

STATISTICA provides a broad base of integrated statistical and graphical tools including:

• Tools for basic research such as Exploratory Graphical Analysis, Descriptive Statistics, t-tests, Analysis of Variance, General Linear Models, and Nonlinear Curve Fitting
• Tools for more advanced analyses such as a variety of clustering, predictive modeling, classification and machine learning approaches including Principal Components Analysis

The STATISTICA platform meets the needs of both scientists and statisticians in your R&D organization.

The STATISTICA platform provides a suite of data mining algorithms directly applicable to the analysis of aggregated data across studies, systems research data, and genetics data, supporting extremely large data sets and those data sets exhibiting high dimensionality.

Quality Control

The STATISTICA Enterprise suite of products aids the compliance and quality control efforts of Pharmaceutical R&D and Manufacturing organizations. STATISTICA is being used to automate the analysis of new samples, empower analysts with easy to use querying tools for accessing historical data (e.g., the samples from January through March), and to automate the production of standard reports (e.g., annual product reviews and stability reports).

STATISTICA provides a wealth of Quality Control techniques including all of the standard Quality Control Charts and specialized charts such as EWMA and CUSUM charts integrated in one software platform that can be used either in automatic updating mode or as an offline tool.

STATISTICA integrates directly with your LIMS repositories. The STATISTICA software stores definitions of these repositories centrally for all STATISTICA Users, so that analyses are easily run on either the latest or historical data. Interactive filtering in STATISTICA is provided through a set of easy to use user interfaces for selecting criteria (e.g., Product(s), Date/Time range, Sample or Batch Numbers, etc.).

Report templating and Report generation are important features for these applications. STATISTICA allows for the central configuration and administration of Report Templates. These Report templates are wedded with the results from the latest analyses to automate the production of standard Reports. The Reports are outputted in PDF, HTML or a Word Processor-compatible (e.g., MS Word) format.

StatSoft's validation services streamline the process of installing, configuring, testing and documenting the validation efforts for a STATISTICA-based application.

Process Analytical Technology (PAT)

Recent guidance from the FDA regarding Process Analytical Technology (PAT) outlines the need for the use of multivariate statistical approaches in the process monitoring of Pharmaceutical manufacturing. New techniques and technologies allow for greater insights into the relationship between manufacturing process variables and the resulting finished product parameters.

STATISTICA MultiStream is StatSoft's software solution designed for PAT applications. It is built on a robust, advanced client-server (and fully web-enabled) architecture; it offers central administration and management of deployment of models and cutting edge root-cause analysis and predictive data mining technology; and its analytics are seamlessly integrated with a built-in document management system. It is a complete enterprise system with numerous features (e.g., security/access control, audit trails, and versioning/history) designed to meet the compliance standards of the FDA regulated industries.

While other solutions may provide simple or multivariate control charting, or (more recently) linear partial least squares (PLS) and principal components analyses (PCA) for batch processes, only STATISTICA MultiStream provides the toolset and capabilities to identify and implement methods to tackle all typical problems that need to be solved in complex modern process manufacturing:

STATISTICA is easy to configure to utilize within your manufacturing environment, integrating directly with your process information repositories, LIMS databases, and MRP systems. Automation in STATISTICA is provided via Visual Basic for Applications (VBA) integrated with the STATISTICA Application Programming Interface (API).

StatSoft streamlines the validation process by providing Validation packages and a suite of installation, configuration, testing and documentation services.