CATO SMS is committed to providing the highest quality services for you. Our global biometrics group is a dedicated, experienced team of biostatistics, statistical programming, and data management professionals devoted to delivering individualized, adaptable, and dedicated services to support all of your data and analytical needs. We strive to provide you with the best solutions and, in September 2020, we acquired Array Biostatistics to expand our biostatistical consulting, analysis, and programming capabilities.

Biostatistics and Statistical Programming

With years of expertise designing and implementing Phase I-IV clinical trials, integrated analyses, and patient registries — along with a dynamic approach and clear communication across all functional areas — we ensure your clinical studies are conducted with efficiency, quality, and scientific integrity. Our experienced team effectively anticipates risks, prevents delays, avoids extra costs, allocates resources appropriately, and develops realistic timelines.

All deliverables are flexible and customized toward meeting your needs. We can act as your primary statistical team to design and execute your clinical study or fill in to provide as-needed support to your existing statistical team — and everything in between.

Our statisticians frequently collaborate and/or meet with regulators in various therapeutic divisions including standard and alternative regulatory paths such as orphan, breakthrough, and fast-track.

  • Sample size and power calculations
  • Randomization schedules, treatment kit lists, blind break documents, masking plans
  • Customized tables, figures, and listings for Phase I-IV clinical trials
  • CDISC database standardization and legacy conversions
  • Data integration and integrated summaries (ISS/ISE)
  • Interim analysis (futility, sample size reestimation, efficacy, endpoint reviews) and safety updates
  • Patient registries
  • Supportive analyses for publications, manuscripts, scientific presentations, abstracts, etc.
  • Adaptive designs
  • Data monitoring committees
  • Biometrics leadership on timelines, handoffs, communication plans, and milestones across data vendors and all functional areas and vendors
  • Review of data management documents and database setup

Our team has CDISC expertise and can set up a CDISC strategy that fits corporate, financial, and regulatory goals. We have created CDISC SDTM and ADaM compliant datasets for over 60 studies and performed many CDISC compliant regulatory submissions.

  • Ongoing studies and historical databases/legacy conversions
  • Programming specifications for SDTM and ADaM
  • SDTM and ADaM domains (SAS datasets/transport files)
  • SDTM annotated CRF (acrf.pdf)
  • Define.xml files for SDTM and ADaM
  • Reviewer’s guides in multiple formats (e.g., PHUSE standard) including validation confirmation and OpenCDISC/Pinnacle 21 notes
  • Study program guides that provide details on how programs and macros are used to create the SDTM and ADaM domains

Our statisticians frequently collaborate and/or meet with regulators in various therapeutic divisions including standard and alternative regulatory paths such as orphan, breakthrough, and fast-track.

  • Regulatory agency meeting support and statistical representation (scientific advice, advisory committees, end of Phase II, pre-submission, etc.)
  • Drug/biologic regulatory submission strategies
  • Regulatory briefing package development and meeting request support
  • Safety reporting
  • Integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) analysis plans
  • Database integration and integrated summaries (ISS/ISE)
  • CDISC database legacy conversions and standardization
  • Post-submission rapid response

We work with your team to identify key objectives from the regulatory, corporate, and scientific perspectives. We then incorporate the objectives into powerful study designs that prioritize key goals and de-risk the development program at strategic go/no-go decision points.

  • Strategic product development plans
  • Individual study protocol development including novel and complex trial designs
    • Adaptive trial design
    • Real-world evidence and/or other external controls
    • Natural history studies
    • Patient registries
  • Exploratory analyses for corporate or scientific support
  • Sample size and power calculations
  • Adaptive trial designs
  • Regulatory submission strategies
  • Statistical analysis plans for Phase I-IV clinical trials
  • Integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) analysis plans
  • Interim analysis plans (futility, sample size reestimation, safety reviews, endpoint reviews)
  • PK analysis plans
  • Patient registry analysis plans
  • Statistical representation as either voting DMC member or as independent external statistician
  • Identify and recruit committee members
  • Prepare and/or review DMC charter and interim analysis plan
  • Prepare masking plans and maintain blinded and unblinded firewalls
  • Coordinate and manage organizational and data review meetings
  • Attend and/or lead meetings
  • Perform statistical analysis (blinded and/or unblinded)
  • QC prepare and distribute DMC data packages
  • Prepare open and closed session meeting minutes
  • Post-meeting follow-up and additional data requests
  • Seamless integration with your statistical team, or CATO SMS can serve as your full-service partner
  • Biometrics project management and oversight of timelines, handoffs, communication plans, and milestones
  • Review of statistical documents and deliverables
  • Statistical/programming review of data management documents and database setup

Data Management

From database design and setup through cleaning and reporting to database lock, CATO SMS delivers timely and quality data by using the latest technologies, robust processes, and regulatory-compliant data management tools. We apply standardized and established processes from electronic case report form (eCRF) design to the delivery of final datasets. We are experts in the development of therapeutic area-specific eCRFs and can manage studies efficiently in any therapeutic indication.

CATO SMS has provided data management services to the biopharmaceutical industry for over 20 years. Our senior clinical data managers and clinical programmers have an average of more than 10 years of industry experience and broad expertise covering all phases (I-IV) extending to registries and observational studies in numerous therapeutic areas. We have experience with a range of electronic data capture (EDC) systems.

Our data management services include:

  • Project data management, planning, and documentation
  • EDC database build and validation (CDASH/SDTM compliant)
  • Data validation plan, edit check programming, testing, and validation
  • EDC maintenance and support
  • Data validation and data quality review for inconsistencies, trends, and outliers
  • Query management
  • Medical coding (MedDRA and WHODrug)
  • SAE reconciliation
  • Planning and management of third-party data
  • Data imports and exports to SAS and other industry standard formats
  • Production and review of real-time metric reports
  • Data integration
  • Electronic patient reported outcome (ePRO) setup
  • IWRS setup and maintenance
  • Insights and analytics
  • Risk-based monitoring support

We carefully select cloud-based EDC systems for their user-friendly interface, additional modular options, real-time data capture, and reporting and information dashboards. All of our EDC systems are regulatory and 21 CFR Part 11 compliant. Our DM team is flexible and will assist you in making the right decision based on your study-specific requirements and preferences. While we often recommend using an in-house preferred EDC platform, our DM team can also support the management and execution of your trial if you choose an alternative EDC. Our data management supports:

  • IBM® Clinical Development
  • Viedoc™
  • Medrio
  • Medidata RAVE (certification 2021)
  • Other sponsor-requested platforms