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Biostatistical Services

reducing costs & accelerating results

Study Design & Protocol Development

Study Design & Protocol Development

Making sure that the statistical foundation of your clinical trial is solid ensures the integrity of your trial, helps reduce costs, and accelerates results.

Using our wide experience from a variety of therapeutic areas and indications, we are able to work with your clinical and management team to give you the best advice on the design of your study and help develop the best statistical analysis methods to support the study objectives.

Our team members also have experience in writing and/or protocol synopses and full-text protocols and can ensure that the analyses follow the most up to date industry practices and regulatory guidance.

For this reason, our sponsors rely on ARA for assistance in writing and reviewing all aspects of the protocol including study design, visit structures, choice of endpoints, sample sizes, and randomization strategies.

Determining the best method to meet your objective

Study Design

Study Design

Our experienced biostatisticians will look at the latest literature and most recent regulatory guidance to suggest the study design that best supports your objectives. Aspects we will consider include:

single, double, or open

Blinding

Blinding
Whether your study is double blind, single blind, or open label we understand how to incorporate the blinding strategy into our overall approach.
simple or complex

Randomization Strategies

Randomization Strategies
Whether you need a simple 1:1 ratio for a single site study, or a more complex adaptive randomization scheme across multiple sites, we can develop the randomization strategy to suit your needs.
Planning Visits

Visit Structure

Visit Structure

How visits are structured in your study can impact multiple aspects of both the database and the statistical analysis. We help you think through how the visit structure impacts these and to mitigate any impacts in advance.

supporting objectives

Endpoint Selection

Endpoint Selection
We review prior studies and literature in the indication to help our sponsors select the most appropriate, scientifically relevant endpoints for their studies. The choice of endpoint, (both primary and any key secondary) is key in supporting the objectives of the trial and the sponsor company.
powering your trial

Sample Size Determination

Sample Size Determination

Our statisticians will help to determine the most appropriate sample size to support your results. We help your team appropriately incorporate historical information and make sure to keep the key study objectives in mind so they can make informed decisions about the assumptions used to design and power their clinical trials.

reviewing pros & cons

Adaptive Designs

Adaptive Designs

More and more, sponsors are recognizing that adaptive designs can allow them to save both time and money in the drug development process, but there are many considerations that should be reviewed prior to jumping in. At ARA, we are able to explain the pros and cons of various approaches with our clients in order to help them to make the best decisions.

Adaptive designs we are familiar with include:

Seamless Ph2/Ph3 trials
Futility Analysis
Basket Trials

Group Sequential Designs
Sample Size Readjustments (blinded/unblinded)

Seamless Ph2/Ph3 trials
Futility Analysis
Basket Trials
Group Sequential Designs
Sample Size Readjustments (blinded/unblinded)

ARA | Biostatistical Services
We make the SAP work for your product

Statistical Analysis Plan

Statistical Analysis Plan

One of the most important documents in a successful clinical trial is a well written and thorough Statistical Analysis Plan (SAP). The SAP is the backbone of the statistical analyses that support the successful registration of your product and at ARA, we ensure the SAP works to fulfill that important role.

There is no cookie cutter approach to statistical analysis for clinical trials – analytical designs are as diverse as the trials’ experimental designs and objectives. ARA understands that pulling together the specifications of the statistical analyses is a collaborative effort with the sponsor to understand the study objectives and how we can best support those objectives.

While writing the SAP we review all relevant and available study documents, regulatory guidance and current literature to define and describe the analysis methodology that will fully support the study objectives. We brainstorm with the clinical team to project all the possible outcomes and then craft the analytical specifications into the SAP.

All derivations, inferential analyses, and statistical methods are delineated as well as details for summarizing the disposition of study participants, definitions of analysis populations, methods for handling missing data and other intercurrent events, details around compliance, and exposure and summaries of safety parameters.

Our team will provide a complete set of Mock Table Shells so you can see what your analysis will look like, so you can make adjustments before it’s programmed, saving your team time and energy in review at final delivery.

We also work with the researchers to ensure that we include any exploratory analysis in the SAP; for example, analyzing a subset of the population for a certain indication. Exploratory analyses can be important for hypothesis-generating and provides researchers valuable information about their assumptions of their product and patients, and is valuable informing the design of future studies

Are you ready to begin your biostatistical study?

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