STATISTICAL PROGRAMMING

Delivering Submission Ready Data with Confidence.

Inference provides submission-ready data packages, guaranteeing that your data will be accepted by the regulatory agencies as we use the latest CDISC standards & guidelines.

Our track record tells the story:
  1. Multiple successful NDAs, ANDAs, and BLAs across diverse therapeutic areas
  2. CDISC experts & tools to automate processes to improve efficiency and quality
  3. 8+ years of consistent statistical and regulatory success

For submissions, organizing data and ensuring traceability are essential for a reviewable package. Inference’s goal is to ensure deliverables meet the highest quality and regulatory standards.

Services Include

All studies starting after December 17, 2016, are required to conform to the CDISC standards. Inference Statistical Programming group creates submission-ready datasets following these standards. We follow theFDA/EMA/PMDA andcurrent CDISC (SDTM, ADaM) requirementsto prepare the submission packages based on the regulatoryrequirements. 

Based on the Charter, Inference statistical programming team generates blinded and unblinded statistical outputs to support to the Data Monitoring and Safety committee. The team also generates ad hoc outputs when requested by the committee.

 

At Inference, weofferhigh-quality patient profile listings, formatted patient profiles, and narrative reports. The statistical programmers collaborate with medical writers to generate accurate patient profiles that assist in understanding individual patient data comprehensively.

All studies starting after December 17, 2016, are required to conform to the CDISC standards. However, studies starting before that date may not be CDISC compliant.

Knowing the importance of legacy study data in a new drug application, we help you modify your legacy data to preferred CDISC standards so that these data can be incorporated in the submission.   

Integrated summaries for safety and efficacy are a crucial component of regulatory submissions to the FDA. There are multiple approaches for developing integrated datasets for ISS/ISE. For example, often these summaries are driven from SDTM datasets of individual studies, and other times they are driven from individual ADaM datasets, or even a mix of SDTM and ADaM datasets. Our programmers and statisticians can navigate through each problem and optimize the approach.

The team has extensive experience with integrated summaries (ISE/ISS) in multiple NDA and BLA filings, contributing to successful drug approvals.

BIMO stands for Bioresearch Monitoring, which supports onsite inspection and data audits performed by the FDA’s Office of the Site Inspection (OSI) team. These programmers have successfully programmed the Clinsite dataset and site-specific listings required for a BIMO.

The Inference programming team, based in the US, work hard to ensure our client’s goals are met and value of our long-term relationships which have facilitated our expansion of services. Our goal is to provide deliverables that are of high quality, efficient, and on time and differentiated by:

  1. Expertise in Regulatory Submissions
  2. Scientific and Statistical Depth
  3. Innovative Tools and Automation

PARTNER WITH US

When you work with Inference, you gain a trusted partner with the experience, tools, and dedication to support your clinical development goals. Let us simplify the complexities of statistical programming and regulatory submissions so you can focus on delivering impactful therapeutic solutions. Connect with the Inference Programming team to discuss further.

OUR EXPERTS

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