Biostatistics and programming

Bio Soft Research global biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance that:

  • Accelerates decision making
  • Reduces risk of compromised timelines and errors
  • Ensures consistency and quality of global deliverables
  • Optimizes efficiencies with robust processes and global infrastructure
Comprehensive experience, tailored biostatistics services

Our comprehensive clinical biostatistics services can be tailored to meet the needs of your project:

  • Clinical development planning, study design, analysis and endpoint strategies, as well as supporting methodologies and statistical analysis plans
  • Randomization schedule creation and integration with investigational product management, interactive response technology (IRT) systems, as well as other project planning needs
  • Scientifically sound interpretation and reporting of results with efficient, quality production of full-output deliverables
  • Real-time analysis presentations and frequent, automated and secure web postings
  • Statistical consulting, design and operation of adaptive design studies for all phases of trials, from initial dose titration through post-approval services
  • Our biostatistics team has been engaged with International Conference on Harmonisation (ICH E9) since the draft guidance was released and is leading a cross-functional working group to ensure full compliance at every stage
Complete, concise biostatistics reporting

Based on a well-developed plan, the statistical analysis implementation provides customers with timely, high-quality deliverables. We ensure complete, concise reporting through:

  • A centralized computing platform that unifies global biostatisticians and programmers, increasing productivity, saving time and enhancing data security
  • Analysis strategies that are ICH-compliant
  • Production of audit-ready tables, listings and figures
  • New drug application (NDA) submission-ready data delivery in Clinical Data Interchange Standards Consortium (CDISC) format
  • Integrated submissions of statistical sections
  • Data and safety monitoring board (DSMB) output, interim analysis and investigational new drug (IND) safety updates
  • Development of comprehensive methods reports describing planned and exploratory analyses
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
  • Support for manuscripts and abstracts
Expert statistical analysis

Our global biostatistics team has a broad range of therapeutic experience, and our statisticians hold advanced degrees. We add value to client projects with data-driven information, analysis, interpretation and study design.

 

Functional service partnership (FSP) model

Drive insights and accelerate outcomes with comprehensive biostatistics services

The right data and insights are necessary at every stage of the development lifecycle to accelerate clinical trials in a competitive environment.

With the flexibility of a functional service partnership (FSP) model, the Bio Soft Research supports biopharmaceutical, biotech, and medical device organizations with comprehensive biostatistics services from innovative study strategy, design, and programming to expert analysis and reporting across all therapeutic areas.

Offering more than statistical analyses, our biostatistics and science expertise forged over 10 years of industry experience brings increased confidence, clarity, and focus to the development of your asset. And our robust technologies, processes, and global infrastructure drive exceptional quality and compliance.

Expertise you can count on

Our biostatisticians and programmers support every stage of the development lifecycle to accelerate timelines, reduce risk and improve the quality of decision-making. From valuable upfront study design to comprehensive planning assistance, our comprehensive solutions encompass all facets of biostatistics and programming, including:

Planning and design
  • Study design and endpoint strategies
  • Adaptive designs, randomization methods and schedules
  • Statistical analysis planning and strategies
  • Feasibility analysis
Evidence and analysis
  • Statistical analysis plans
  • Modelling and simulations
  • Powerful and innovative statistical methodologies
Reporting and submission
  • Comprehensive and concise reporting of key results and statistical assessments
  • Integrated analyses and data visualizations
  • Regulatory submission support and representation
  • Support for manuscripts, abstracts and data safety monitoring boards
Propel quality and compliance with robust technologies, processes and global infrastructure

Collecting and analyzing data is complex. By partnering with our experts, you gain access to solutions, processes, tools and technologies both industry standard and proprietary that drive quality, efficiency and compliance with every deliverable. Some of the systems we employ include:

  • Biostatistics Technology Infrastructure (BTI) – proprietary SAS-based computational platform that combines hardware, software, and global processes to provide complete traceability, version control, and speed for project deliverables
  • Data Transfer Exchange (DTX)– is a game-changing suite of macros to assist in the creation of study data tabulation model (SDTM) and non-standard transfers through a metadata-driven approach
  • Define on Demand (DOD)– The CDISC Define -XML standard represents the industry standard for all eCRTs (electronic Case Report Tabulations)
  • Program Builder Tool (RACE-PBT)– uses metadata to create executable SAS Programs that produce outputs and templates sheets to use for future studies to provide cost savings, faster deliverables and high quality
  • Preclarus™– proprietary patient data dashboard that provides a dynamic visualization-based view of SDTM data
  • FACTS™– software to model, simulate and execute early-stage adaptive trials
  • East®– software to model, simulate and execute later stage adaptive trials
  • R – is a programming language for statistical computing and graphics

Keeping pace with the rapid evolution of our industry requires agility. From adopting wearables and data collection devices, to leveraging virtual sites, to applying metadata solutions to our statistical deliverables, we’re prepared to quickly adapt procedures and apply the latest cutting-edge technical solutions to your project.

We’re also leaders in our industry’s knowledge and understanding of global regulatory requirements and take an active role in standards development. We support and contribute in several ways:

  • Participant in the CDISC advisory board, the submission data standards, and Clinical Data Acquisition Standards Harmonization (CDASH) teams
  • Engagement with International Conference on Harmonisation (ICH E9 (R1)) since draft guidance was released to lead a cross-functional estimands working group to ensure compliance

Our global infrastructure also supports client-specific support for country, regional and global deliverables with consistent worldwide standards of quality delivery. Our working practices include:

  • Programming based on written specifications
  • Independent quality validation of formal deliverables to verify accuracy and audit readiness
  • Senior statistical review of all statistical deliverables, from protocol writing through regulatory submissions
Customized solutions to meet your specific needs

Before awards are made, we ensure your specific needs and expectations are fully understood, which enables teams to be quickly allocated to meet your precise requirements.

To span all time zones and provide 24-hour coverage to you, we have employees located across the globe, with key locations in USA and India. Crucial client-facing roles are strategically placed in the same time zones as your functional and clinical teams, so our combined team becomes a unified group integrated with your biostatistics function.

Our project teams are designed to plan and execute the study analyses efficiently and with scientific integrity. Each project team is empowered with the flexibility to provide solutions that meet your unique needs and include a customized mix of roles. A typical team may include a lead biostatistician, a senior statistical reviewer, a lead programmer and additional supporting staff.

Biostatistics team members have a broad range of therapeutic experience, most often holding advanced degrees. In collaboration with the client’s assigned clinical and statistical scientists, our assigned lead biostatistician will create a detailed statistical analysis plan (SAP) for the study.

Dedicated staff managers ensure that all staff assigned to a partnership receive internal training along with specific project and therapeutic training and “just-in-time” training for particular tasks. All our statisticians and statistical programmers also receive ongoing, intensive training that incorporates:

  • Industry information such as 21 CFR Part 11
  • Good Clinical Practice (GCP) and ICH standards
  • SAS®software programming skills
  • Statistical methodology including adaptive design

With this proven approach, we collectively create successful teams, encourage knowledge sharing, and produce positive, productive interactions throughout the duration of our partnership.