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 the FDA/PMDA and current CDISC (SDTM, ADaM) requirements to prepare the submission packages based on the regulatory requirements.

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

We develop therapeutic and disease-specific custom macros to create visuals to assist in data reviews for ongoing studies.

At Inference, we offer high-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 modify your legacy data to preferred CDISC standards to incorporate them into the submission package.

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. Inference programmers have successfully programmed the Clinsite dataset and site-specific listings required for a BIMO.