Tibco Statistica
Comprehensive Analytics and Business Intelligence for Life Sciences


TIBCO Statistica is a powerful data analytics platform designed for the life sciences industry. It offers advanced analytics tools and algorithms which help companies to uncover valuable insights from pharmaceutical data. The Statistica platform has many benefits and use cases:

  • Provides a user-friendly interface for data-driven decisions
  • Integrates with various sources, handles big data, and deploys on-premises or in the cloud
  • Facilitates model deployment and automation
  • Offers industry-specific solutions, streamlining analytics and delivering tailored insights 
  • Helps optimize data analysis, gain a competitive edge, and make informed decisions
  • Adheres to current FDA system and data integrity compliance requirements


Why Choose Tibco Statistica?

TIBCO Statistica is an ideal choice for life science clients due to its comprehensive analytics capabilities, industry-specific solutions, and regulatory compliance. The software can easily be designed and implemented to be FDA compliant, ensuring adherence to regulatory guidelines and validation requirements. 

The Statistica platform empowers companies to optimize research and development, enhance manufacturing processes, and make data-driven decisions. With a user-friendly interface and scalability, Statistica enables efficient data analysis and data integration, faster time-to-market, and a competitive edge in the highly regulated life science industry.

Who Can Take Advantage?

Statistica offers pharmaceutical companies the ability to accelerate drug discovery and development, ensure regulatory compliance and quality control, and gain insights for personalized medicine. By leveraging these capabilities, pharmaceutical companies can enhance their competitiveness, streamline processes, and deliver better treatments to patients.

In the gene therapy space, Statistica is used for gene expression analysis, patient stratification, manufacturing process optimization, predictive modeling for clinical trials, and pharmacovigilance. It helps identify gene therapy targets, optimize treatment strategies, improve manufacturing processes, enhance clinical trial design, and monitor safety and efficacy.


Statistica Core Features

Life sciences companies can benefit from using Statistica for the following three main reasons:

  1. Enhanced Drug Discovery and Development: By analyzing vast amounts of data, including clinical trials, genomic information, and preclinical research data, the software helps identify potential drug candidates, predict drug efficacy and safety, and optimize trial design. This leads to more efficient research, reduced costs, and faster time-to-market for new drugs.


  2. Improved Regulatory Compliance and Quality Control: The pharmaceutical industry is subject to rigorous regulatory standards and quality control requirements. TIBCO Statistica provides robust statistical analysis capabilities that enable companies to ensure compliance with regulatory guidelines and maintain the highest standards of quality control. It supports statistical process control, capability analysis, and validation of manufacturing processes, ensuring adherence to regulatory standards and minimizing the risk of non-compliance or product recalls.


  3. Enhanced Patient Insights and Personalized Medicine: Personalized medicine is a growing trend in the pharmaceutical industry, aiming to provide targeted treatments based on individual patient characteristics. TIBCO Statistica enables pharmaceutical companies to analyze patient data, such as electronic health records, genetic profiles, and demographic information, to gain valuable insights into patient populations. By leveraging advanced analytics and machine learning algorithms, the software helps identify patient subgroups, predict treatment responses, and support the development of personalized therapies, ultimately improving patient outcomes and satisfaction.

Lean Biologix Recommends These 4 High Value Application Areas


Regulatory Compliance: The pharmaceutical industry operates under strict regulations and guidelines from regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). TIBCO Statistica provides statistical tools and capabilities to ensure compliance with these regulations. It assists in the analysis and interpretation of data required for regulatory submissions, helping companies meet the necessary standards and requirements. The platform supports the validation of manufacturing processes, ensuring that pharmaceutical products are manufactured consistently and meet the desired quality standards.

Statistical Process Control (SPC): TIBCO Statistica enables pharmaceutical companies to implement Statistical Process Control techniques to monitor and control manufacturing processes. SPC allows for real-time monitoring of critical quality parameters, such as temperature, pressure, or pH levels, during the manufacturing process. By analyzing the collected data, the software can identify any process variations or deviations from the desired specifications, helping companies maintain process stability and minimize the risk of defects or inconsistencies in the final product.

  • Statistical Process Control (SPC): SPC is a methodology used to monitor, control, and improve manufacturing processes. It involves collecting and analyzing data in real-time to detect process variations and deviations from desired specifications. By using SPC, pharmaceutical companies can ensure that their manufacturing processes are stable, predictable, and within the defined quality limits.
  • Real-time Monitoring: TIBCO Statistica enables real-time monitoring of critical quality parameters during the manufacturing process. It connects to data acquisition systems, sensors, and other process monitoring tools to capture data continuously. The software provides visualization tools and real-time dashboards that display process metrics and performance indicators, allowing operators and quality professionals to monitor the process at any given time.
  • Process Variation Detection: Statistica utilizes statistical techniques to detect process variations and anomalies. Control charts are commonly used in SPC to visually display data over time and identify any patterns or trends that fall outside of acceptable control limits. When a process variation occurs, the software can trigger alerts or notifications, enabling timely intervention by operators or quality control personnel to investigate and address the issue.
  • Root Cause Analysis: When a process variation is detected, Statistica can assist in identifying the root cause of the problem. The software provides advanced analytics capabilities to perform root cause analysis by examining the relationships between process parameters and quality outcomes. It can identify variables or factors that significantly influence the process and contribute to variations, helping companies pinpoint the root cause and implement appropriate corrective actions.
  • Continuous Improvement: TIBCO Statistica supports continuous improvement initiatives by facilitating process optimization and reducing variability. By analyzing historical process data, the software can identify areas for improvement and suggest optimization strategies. Additionally, it enables companies to track and compare process performance over time, assess the effectiveness of process improvement initiatives, and ensure that the desired improvements are sustained.


Quality Control and Assurance: TIBCO Statistica offers a range of statistical analysis tools for quality control and assurance in pharmaceutical manufacturing. It supports methods such as capability analysis, control charts, and sampling plans to assess and monitor product quality. These tools help identify any variations or trends that may indicate potential quality issues, allowing companies to take corrective actions proactively. By ensuring consistent quality throughout the manufacturing process, pharmaceutical companies can reduce the risk of product recalls, protect their brand reputation, and maintain compliance with regulatory requirements.


Data Integrity and Audit Trail: Data integrity is critical in the pharmaceutical industry, and TIBCO Statistica provides mechanisms to ensure the integrity and traceability of data throughout the analytics process. The software offers features such as data validation, audit trails, and version control, ensuring that data used for analysis is accurate, complete, and secure. This helps companies demonstrate data integrity to regulatory authorities during audits and inspections, ensuring compliance with regulatory expectations.

What to Ask a Shipping System Vendor?

Why choose a pre-qualified shipping system? At some point when designing a supply chain, a system for transporting the product must be developed or selected from available shipping system vendors. The most straightforward and least time intensive option is selecting a...

Comparing ASTM D4169-16 to ASTM D4169-22

What is ASTM D4169 testing? ASTM International developed the standard ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” to test a shipping systems’ ability to withstand typical distribution hazards that occur in a supply...

Supply Chain Considerations: ISTA Thermal Profiles for Shipper OQ

The purpose of this article is to explain why you may choose an established ISTA profile in lieu of using a custom profile for OQ temperature validation studies. The established ISTA ambient profiles are industry tested and widely accepted globally, whereas custom...

Whitepaper: Evaluation of Shipping System Qualification Data

The Lean Process Learn and apply industry best practices within your qualification processes to evaluate qualification data provided by thermal shipping system manufacturers and vendors. Leveraging pre-existing qualification packages is a tremendous time and resource...

Gene Therapy Shipping Qualification

A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market. Internal stakeholders needed to tightly manage the timeline required for...

Overcoming a Challenging In-Country Distribution Model

A leading fortune 500 company headquartered in Cambridge, MA was planning to launch a number of biological products into new markets for the first time. Product specific shipping qualification was performed and qualified shipping containers were in use for domestic...

CDMO Platform Shipping Strategy/Qualification

A leading cell and gene therapy CDMO located in Cambridge, MA desired to qualify and implement platform shipping systems that could maintain their product requirements and regulatory compliance.   Challenges Aggressive timeline to complete qualification and...

How can we help?