We leverage our vast statistical experience gained through the conduct of academic research and commercial clinical trials to apply innovative statistical methods in a way that speeds submissions.
We plan the analyses you will need before the study begins and provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses. Our thorough validation and quality control processes eliminate the need for corrections and ensure accurate results. Alimentiv is a CDISC Gold Member with CDISC “Trailblazer” status due to our continued involvement and contributions to new IBD-specific standards. Our unique experience in consulting and operationalizing CDISC/SDTM/ADaM standards for our clients includes data consolidation, migration, and conversion.
At Alimentiv, we have decades of experience applying innovative methodology to answer clinical questions.
Adaptive (Bayesian) trial design
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.
Phase I – IV experience
Our biostatisticians have experience designing early phase proof of concept studies, phase I/II PK and PD studies, dose-finding safety and efficacy studies as well as large phase II/III trials. We have also designed and analyzed a wide range of phase IV studies.
Sample Size and Power Calculations
We will work with you to define the study objective and select appropriate study endpoints to support the trial hypothesis. Based on the selected endpoints, our biostatisticians will calculate the number of study participants that will need to be enrolled to reject the null hypothesis with an acceptable level of statistical power. Our team can also provide advice about strategies and trade-offs that might be employed to minimize sample size requirements if time or cost considerations exist.
Our biostatisticians will advise you on the best approach to randomization based on your study design and operational considerations:
- Simple randomization
- Blocked randomization
- Stratified randomization
- Adaptive randomization, including minimization
Our team has experience defining study estimands and putting ICHE9(R1) into practice. We understand the various factors that influence how estimands are developed and can walk you though the various strategies for handling study intercurrent events.
Statistical and Methodological consultation
Our statisticians have extensive experience in the GI therapeutic area, and can provide stand-alone statistical consulting services to assist you with appropriate trial design, including development of study estimands, and analytical approaches.
CDISC (SDTM and ADaM)
For Alimentiv, CDISC standards compliance starts at data collection and carries throughout the entire data analysis. Our CRFs are designed using CDASH standards which allows for efficient conversion to submition-ready SDTM and ADaM datasets. This shortens timelines to submission and allows for seamless integration of data 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:
- Simple randomization
- Annotate the eCRF for SDTM domains
- Map the data fields to the SDTM domains
- Develop SDTM specifications
- Program and validate the SDTM domains
- develop define.xml and Study Data Reviewer’s Guide (SDRG)
- Provide quality control throughout the process
We offer the flexibility to adhere to whichever version of SDTM fits your needs and the clinical area expertise to give you confidence when it comes time to submit your results.
Our team has experience defining study estimands and putting ICHE9(R1) into practice. We understand the various factors that influence how estimands are developed and can walk you though the various strategies for handling study intercuAt Alimentiv our biostatisticians will custom design your ADaM datasets to fit your analysis and reporting needs. Our standard process is as follows:
- Map the SDTM to ADaM domains
- Review the Statistical Analysis Plan (SAP) to determine which derived variables are required for analysis
- Develop the ADaM specifications
- Program and validate the ADaM domains
- develop define.xml and Analysis Data Reviewer’s Guide (ADRG)
- Provide quality control throughout the process
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.
Statistical Analysis Plan
We have extensive experience developing statistical analysis plans and shells for tables, listings and figures.
Our statisticians play a significant role in protocol and eCRF development with the goal of ensuring 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. Our team can carry out interim analyses in a timely manner based on study recruitment milestones, in order to facilitate decision making.
Data Monitoring Committee (DMC)
Our statisticians play a significant role in protocol and eCRF Alimentiv’s biostatistics team will work with the sponsor and project team to:
- Develop the DMC Charter and mock DSMB reports
- Define the stopping rules if required
- Create and present DSMB reports at meetings (closed session)
- Manage requests for unblinding, as required
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
Reporting and Data Transfers
At Alimentiv, we offer a wide variety of standard reports on data quality, statistical monitoring, and study progress but can also work with you to develop customized reports tailored to your study’s requirements. For our imaging studies, our standard is to provide data transfers in a SDTM-ready format that can easily be incorporating into your overall SDTM package.
Alimentiv has extensive experience programming tables, figures, and listings to support study reports, interim analyses, 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).
Validation and Quality Control
All statistical deliverables from Alimentiv are validated to ensure high-quality and accurate results. Our QC process involves independent double programming and/or code review and/or output review.