Accelerate your clinical trial submissions with real-time SDTM conversion and expert data standardization

In today’s fast-paced clinical research environment, regulatory readiness starts with structured, validated data. At Amarex Clinical Research, we specialize in transforming raw clinical trial data into fully compliant, submission-ready Study Data Tabulation Model (SDTM) datasets—faster, smarter, and with unmatched precision.

Our real-time SDTM process ensures early issue detection, seamless collaboration, and regulatory confidence from day one. Whether you’re preparing for FDA, EMA, or PMDA submission, Amarex delivers the expertise and tools to keep your trial data clean, compliant, and audit-ready.

Why Choose Amarex for SDTM Services?

• Real-Time SDTM Conversion: We don’t wait until the end of your study to start formatting your data. Our real-time SDTM conversion process allows us to format and validate data as it’s collected—minimizing delays, reducing risk, and enabling faster interim analyses.
• Global Regulatory Expertise: With deep knowledge of CDISC standards and extensive experience supporting submissions to the FDA, EMA, and PMDA, our team ensures your datasets meet the highest standards of regulatory compliance.
• End-to-End Data Integrity: From SDTM mapping and annotated CRFs to Define.xml and the Reviewer’s Guide, we ensure your data is consistent, traceable, and fully aligned with regulatory expectations.
• Collaborative Approach: Our process is built for transparency and teamwork. We work closely with your clinical, data management, and biostatistics teams to ensure alignment across all functions—promoting efficiency and reducing rework.
• Validated & Audit-Ready: All SDTM datasets undergo rigorous validation using Pinnacle 21 Community, ensuring your submission is clean, compliant, and ready for regulatory review.

What We Deliver

• SDTM Mapping Specifications.
• Annotated Case Report Forms (aCRFs).
• Define.xml Metadata Files.
• SDTM Reviewer’s Guide.
• Pinnacle 21 Validation Reports.
• Final SDTM Datasets in SAS, Excel, and Transport Format.

Let’s Make Your Data Submission-Ready—From Day One

Whether you’re running a global Phase III trial or preparing for your first regulatory submission, Amarex helps you stay ahead of timelines, avoid costly delays, and deliver high-quality data with confidence.