Analytic Services

Supporting your Product Lifecycle with a High-Integrity Data Pathway

Data quality is the most important thing in any clinical trial. Our highly trained group of PhD and MS biostatisticians, programmers, and data analysts provide services to ensure that your data quality supports your trial goals and regulatory needs. These services include trial design and statistical methodology consultation, programming expertise, data review, reporting tools and data presentation expertise necessary to deliver your trial outcomes in a timely fashion. BBA’s in-depth understanding of regulatory and clinical requirements play a critical role in the application of statistical and research methodological principles for the design, execution and analysis of clinical trials. Our team will work with data management to implement best practices, ensuring clean, analyzable data along the way. Data analysis is performed using industry-standard software, ensuring that every phase of your trial is optimized for maximum results.

Our analytic team works closely with Sponsors to develop the most appropriate statistical methodology for your trial, including Bayesian and Frequentist Adaptive designs.

At BBA our statistical experts provide support for all phases of the product lifecycle, including:

Pre-clinical Support

Study Design and Analysis

  • Design optimization
  • Data analysis and reporting

Study Start-up

Strategic Consulting and Study Design

  • Identifying the best clinical trial design
  • Implementing innovative Frequentist and Bayesian adaptive designs
  • Defending statistical strategy while interacting with regulators

Statistical Services – Trial Design and Protocol Input

  • Power and sample size calculations
  • Statistical review of protocol and CRF
  • Author statistical sections of the protocol
  • Development and author atatistical analysis plans
  • Identifying data review needs and reports to ensure quality data


  • Authorship of randomization plan
  • Production of randomization schedule

Execution and Report Submission

Specialist Statistical Services

  • Statistical modeling/Exploratory analysis
  • Statistical Representation with Regulatory Agencies

Interim Analyses

  • DMC statistician participation
  • Production of Interim Analyses

Statistical Programming and Validation

  • Tables, Listings and Figures
  • Generation of Analysis Datasets
  • Safety Committee reports

Analysis, Reporting, and Publications

  • Patient Profiles and ad-hoc reports
  • Statistical Reports (Regulatory Submissions, Manuscripts, Investor Relations)
  • TLF creation, In-text table and appendix

Operational Support

Analytics Support

  • Centralized Monitoring Strategy and analytic tool implementation
  • Trial Key Risk Indicator identification
  • Customized trial dashboard specification
    and production
  • Data review team leadership

Our experienced team provides integrated and efficient processes to capture, clean and analyze your data, allowing you to demonstrate safety and efficacy with confidence.

Let Us Help You Navigate the Course

We are delighted to have worked with a company like BBA that offered us the full spectrum of clinical and data management services, with an integrated approach to study design, data management, statistical analysis and report generation. BBA’s team of industry leading experts was committed to servicing our needs and delivered high-quality results.
— Barbara S. Lindsay, Vice President at Benvenue Medical, Inc.

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