Our expert biostatisticians have extensive experience collaborating with clinical researchers and regulatory agencies. We offer deep knowledge of all aspects of clinical trials, from the initial study design and sample size calculations to data analysis, presentation, and interpretation of data.
By leveraging our vast statistical experience gained through academic research and commercial clinical trials, we apply innovative methodologies that accelerate submissions and make a significant difference in your project’s success.
We proactively plan analyses before your study begins and deliver timely, accurate reports, statistical summaries, and efficacy/safety analyses as your study progresses. Our rigorous validation and quality control processes ensure accurate results and eliminate the need for corrections. As a CDISC Gold Member with “Trailblazer” status, Alimentiv Statistics is uniquely experienced in consulting and operationalizing CDISV/SDTM/ADaM standards for our clients, including data consolidation, migration, and conversion.
At Alimentiv, we have decades of experience applying an innovative methodology to answer clinical questions.
Adaptive trial design is a set of methodologies that can be used to reduce the timelines and costs in clinical trials by allowing modifications to the study design and/or statistical procedures after the study has been initiated, without undermining its validity and integrity.
These methodologies offer potential advantages to the traditional approach in terms of flexibility, efficiency and speed. Alimentiv has experience successfully implementing several adaptive strategies to achieve these efficiencies.
Our biostatisticians have experience designing a wide range of clinical trials, including:
We will work with you to define clear study objectives and select appropriate endpoints to support the trial hypothesis. Based on the selected endpoints, our biostatisticians will calculate the number of study participants needed to reject the null hypothesis with an acceptable level of statistical power. We also offer expert guidance on strategies and trade-offs to potentially minimize sample size requirements if time or cost constraints are a concern.
Our biostatisticians will advise you on the best approach to randomization based on your study design and operational considerations:
Our team is well-versed in defining study estimands and putting ICHE9(R1) into practice. We understand the various factors that influence estimand development and can walk you through the various strategies for handling study intercurrent events.
Our statisticians have extensive experience in the GI therapeutic area and offer stand-alone statistical consulting services to assist you with appropriate trial design, including the development of study estimands, and analytical approaches.
For Alimentiv, CDISC standards compliance starts with data collection and continues through analysis. Our case report forms (CRFs) are designed using CDASH standards, ensuring efficient conversion to submission-ready SDTM and ADaM datasets. This streamlined approach accelerates submission timelines and facilitates seamless data integration across clinical programs.
Alimentiv’s experienced SDTM team will work with you to smoothly map your data into SDTM domains. Our standard process is as follows:
We offer the flexibility to adhere to any SDTM version that best suits your needs, along with the clinical area expertise to give you confidence when it comes time to submit your results.
At Alimentiv, our biostatisticians will custom-design your ADaM datasets to fit your analysis and reporting needs. Our standard process is as follows:
Alimentiv is committed to employing the most rigorous and appropriate methodologies in statistical analysis. We employ a wide range of statistical methods ranging from simple two-group comparisons of means or proportions, through survival analysis, multivariable regression models, mixed-effect models, inferential statistics, propensity scores and more.
Our statisticians play a significant role in protocol and eCRF development to ensure high-quality, consistent, and complete datasets.
Our team will help to define when an interim analysis is appropriate and how it will affect the study design and sample size. We can efficiently conduct interim analyses based on study recruitment milestones to facilitate decision-making.
Our statisticians play a significant role in protocol and electronic Case Report Form (eCRF) development. Alimentiv’s biostatistics team will work with the sponsor and project team to:
Alimentiv has SOPs in place to ensure a strong firewall exists between blinded and unblinded staff.
Our experienced statistical programmers offer a variety of services including study-specific reporting, CDSIC conversions, TFLs, and data transfers.
At Alimentiv, we offer a wide variety of standard reports on data quality, statistical monitoring, and study progress. We also work with you to create custom reports tailored to your specific study requirements. For imaging studies, we provide data transfers in a convenient SDTM-ready format that seamlessly integrates into your overall SDTM package.
Alimentiv has extensive experience programming tables, figures, and listings to support study reports, interim analyses, the Data Monitoring Committee (DMC), and manuscripts. All TFL programming is based on shells developed by our biostatisticians as part of the statistical analysis plan (SAP).
All statistical deliverables from Alimentiv are validated to ensure high-quality and accurate results. Our Quality Control (QC) process involves independent double programming and/or code review and/or output review.
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