Introduction
As regulatory demands intensify, the challenge for sponsors is not just to produce SDTM-compliant data, it must be done rapidly, accurately, and at scale. Traditional SDTM programming can be resource-intensive, especially when managing frequent updates or pooled submissions.
At Phastar, our MAPIT automation tool redefines how SDTM packages are created, combining metadata-driven processes, artificial intelligence (AI), and automation to deliver high-quality outputs faster and more efficiently.
Accelerating SDTM Delivery
Phastar’s commitment to early SDTM delivery means that, once a study database goes live, SDTM outputs can be produced in as little as three weeks, without relying on live data.
This speed is made possible through automation driven by database design specifications, eliminating manual setup and enabling near-instant transformation once data extraction begins. Within days, sponsors receive a fully formatted, regulatory-ready SDTM package, including annotated CRF, define.xml, and Reviewer’s Guide.
Metadata-Driven Efficiency
At the heart of MAPIT lies a metadata-driven approach that ensures traceability, flexibility, and consistency. Each study element, source data, client standards, and SDTM implementation guide, is stored centrally. When a change occurs, the system automatically identifies affected components and updates them, cutting rework by up to 70%.
This design future-proofs studies against inevitable protocol amendments and database updates, ensuring alignment with regulatory expectations without the burden of repetitive manual updates.
AI Integration for Intelligent Mapping
AI enhances MAPIT by analyzing study structures, identifying optimal mappings, and suggesting SDTM transformations. This intelligent support reduces manual input, accelerates setup, and minimizes errors, while every AI-generated mapping is reviewed by experienced programmers to maintain accuracy and compliance.
The result: up to 80% of the SDTM creation process can be automated, significantly improving turnaround times and confidence in deliverables.
Flexibility and Reusability
MAPIT supports all major EDC platforms and generates code in SAS or R, ensuring seamless integration with existing sponsor systems. Reusable mappings from past studies are stored in a growing metadata library, turning every project into a cumulative resource that enhances future efficiency.
For repeated or pooled analyses, such as those needed for Integrated Summaries of Safety (ISS) and Integrated Summaries of Effectiveness (ISE), this translates to faster harmonization and consistent outputs across multiple trials.
Delivering Real Value for Sponsors
By leveraging automation and AI, Phastar’s MAPIT reduces timelines and costs by up to 50% for typical Phase III studies, while maintaining full compliance with CDISC standards. Whether implemented as part of a full-service project, FSP model, or software-as-a-service offering, Map IT empowers sponsors to transform SDTM delivery, turning what was once a bottleneck into a competitive advantage.
Discover how Phastar’s MAPIT automation tool combines speed, consistency, and intelligence to transform SDTM delivery.
