We anticipate your statistical design, analysis, and reporting needs with results-oriented approaches

// Biostatisics

The right results begin with carefully calibrated design and management. Axio Research’s biostatistical consulting and analysis specialists will partner with your organization every step of the way. Our services encompass clinical trials in a broad range of therapeutic areas—from preclinical through Phase IV. We design, implement, evaluate, and provide reporting on trials of any phase. Our services include:

  • Protocol development and/or review
  • Sample sizes for trials or assay validations
  • Randomization schema, including adaptive and seamless designs
  • Epidemiological and observational studies
  • Instrument development and validation
  • SAS programming
  • Data Monitoring Committee (DMC) support
  • Ad hoc statistical consulting

Additional writing services we can provide to your organization include: study protocols, statistical analysis plans, interim analysis sequential monitoring plans, and charters for data monitoring committees.

We also provide statistical guidance, preparation, and representation for meetings with the FDA. Our biostatisticians are frequent guest lecturers for the University of Washington’s biostatistics, clinical trials, and regulatory affairs programs.

Data Monitoring Committees

Axio’s biostatistical group offers deep expertise in supporting data monitoring committees (DMCs). Based on your requirements, Axio can select committee members, prepare your charter, and merge treatment assignments with clinical data. Our comprehensive services for DMCs also include creating and presenting open and closed reports, completing meeting minutes, and providing institutional review board (IRB) notification documents.

We deliver accurate, polished reports within tight timelines and will act as liaison between you and your DMC.

Interim Monitoring

Tackling interim-monitoring plans requires highly specific expertise. Our biostatistical specialists will consult with you on resolving the complexities. We can provide you with an array of interim-stopping boundary possibilities that are commensurate with the clinical question and enrollment achievability of your trial objectives. We will work with your team to assist you in deciding among the options available. Our specialists are adept at making use of EAST, Seq Trial, SAS PROC SEQDESIGN, and a number of other less well-known software tools in calculating interim boundaries.

In addition to efficacy boundaries, we can also prospectively run through the range of scenarios available to your study for predetermined safety stopping rules. This may include organizing your data to indicate the numbers of serious adverse events (SAEs) in each treatment group that would need to be observed in order to indicate a specific level of imbalance between groups (e.g., 1 vs. 4, 1 vs. 8, etc.).

Study Designs

Axio biostatisticians have a great track record in consulting on all types of study designs. We have a close relationship with the University of Washington, where much of the methodology for adaptive trial design was developed; many of our biostatisticians studied alongside the biostatisticians who developed these methods. Adaptive designs allow consideration of factors such as a change in event rates with advances in medicine during an ongoing study—but also present some difficulties with interpretation of results. We can help.

Submission Documents

Producing final statistical reports and integrated summaries of efficacy and safety can be an enormous undertaking. Let Axio take the lead. The dedicated team of experts we assemble will thoroughly know your protocol and your data.

Axio respects your deadlines. When we work in concert with other clinical research organizations (CROs) or individuals whose contributions affect your time line, we will remain proactive in helping you keep your study or submission on track.

Attractive, Informative Data Presentation

Attractive, clear, and precise data presentation is a hallmark of Axio’s graphics team. Easy-to-read fonts, clear headers and subtitles, and transparent names will make your publications stand out. Our graphic capabilities include:

  • Forest plots
  • Patient profiles graphs
  • Advanced Kaplan-Meier plots
  • CONSORT-style diagrams of disposition
  • Adverse event (AE) data displays
  • Waterfall plots
  • Chronological truncated box plots: These show how study subjects moved around within the interquartile range over time. They also graphically present the distribution of subjects within the normal range, the percent of subjects who fell out of the normal range, and other detailed data.
  • Study accrual data trends displayed as a multi-bar plot with a contrasting-color expectation line superimposed over it for each time period
  • Easy-to-read survival plots showing: numbers at risk, number of events, number remaining at risk, and the survival function at selected time points
Special Services

We understand how your trial’s endpoint selection critically impacts sample size, clinical event monitoring, and final analysis of your trial. Adjudicated endpoints, composite endpoints, and other special approaches will be carefully considered early in your development program. As an example, we are skilled at utilizing special survival analysis models to account for late-treatment effects.

Axio’s biostatisticians have advised sponsors on modeling approaches that have helped to save their studies. These have included accruing a minimum number of events, broadening the endpoint, increasing enrollment, minimizing dropouts and loss to follow up, and initiating enrichment strategies to enroll more people prone to an event.

Statistical Capabilities

Axio’s biostatisticians are a diverse and talented group. Our PhD and master’s-level biostatisticians bring accomplished and eclectic experience in multiple disciplines including medicine, health economics, toxicology, pharmacokinetics, epidemiology, bioinformatics, data management system design, agricultural econometrics, actuarial science, and process control engineering. We are active in the professional and academic community, attending FDA and ASA meetings, participating in courses and webinars, preparing abstracts, manuscripts, and other communication materials, and giving presentations at scientific sessions.

Statistical Techniques: The experience we will bring to your specific project is deep and far-reaching. The many techniques in which our biostatisticians excel include: longitudinal models, generalized estimating equations, mixed-effects models, accelerated failure time and time-dependent proportional hazards models, ANOVA, ROC curve regression, time series, ordinal and categorical logistic regression, multiple imputation techniques, Poisson regression, propensity score matching, spatial statistics, financial risk models, Bayesian cost-effectiveness models, and instrument development and validation.

Programming Capabilities: The programming capabilities of our staff members include: Action Script, Ajax, Flex, C, C++, C#, Drupal, HTML, Java, Lisp, Mathematica, MAPLE, .Net, Objective C, Open GL, Perl, PHP, R, Ruby, Ruby on Rails, SAS, SEqTrial, SPlus, SPSS, SQL, Stata, Visual Studio, and WinNonlin. We maintain an extensive code library that enables us to quickly produce reports to your specifications. Several of Axio’s expert SAS programmers participate on the General Occurrences subteam of the CDISC ADaM team.

Randomization Services

If it can be accomplished, we’re the experts to turn to: Axio’s biostatisticians can create and recommend randomization schemes that accomplish the ends of your trial and avoid imbalances whenever possible. The statistical ramifications of using blocks, strata, or baseline and response adaptive techniques will be carefully considered in advance of your trial.

Your ability to keep your trial running expeditiously matters to us. We maintain a Help Desk to provide technical assistance to users of our Web systems. The desk is supported with phone backup during non-business hours for problems or questions regarding critical functions such as randomization or emergency unblinding. Help Desk personnel have 24-hour immediate access to an on-call biostatistician if urgent questions arise. To maintain necessary blinding, team members providing these services are not involved in the daily management of the study.

// Pre-Clinical Biostatistics

Axio biostatisticians can advise on and develop a statistical analysis plan that is right for your unique study or compound. Our specialists have experience with parametric and non-parametric statistical analyses in the full range of good laboratory practice (GLP) and non-GLP studies, including General Toxicology, Developmental and Reproductive Toxicology (DART), Immunotoxicology, Carcinogenicity, and Cardiovascular and Respiratory Safety.

AXIO STAFF ACTIVITIES: Giving Back to the Community

Axio employees have been involved in numerous biostatistics-related community projects, including:

  • Participating in “Statistics Career Day” for high school and college students
  • Teaching math to middle-school children in the community
  • Hosting high school and college mathematics students at Axio to learn what statisticians do
  • Producing symposia for training new DMC biostatisticians
  • Giving lectures to a local nursing journal club
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