We create clear, detailed specifications for SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets, ensuring consistency, regulatory compliance, and efficient data analysis. Our structured approach enhances data integrity and facilitates seamless clinical reporting.
Development and Validation of SDTM and ADaM Datasets- Tables, listings, and figures (TLFs)
We develop SDTM and ADaM datasets tailored to your study data, ensuring accuracy, consistency, and compliance with CDISC (Clinical Data Interchange Standards Consortium) standards. Our team conducts rigorous validation to guarantee high-quality, submission-ready datasets for seamless regulatory approval. Our team specializes in developing Tables, Listings, and Figures (TLFs) that comply with regulatory requirements and industry standards. We also create and document programming specifications to ensure reproducibility, traceability, and seamless regulatory submissions.
CRT Package/ Data Exchange
As part of our statistical programming services, we offer expertise in CRT Package and Data Exchange. Our team specializes in developing and delivering SDTM Define.XML, ADaM Define.XML, and other essential components to facilitate seamless data exchange and regulatory submissions.
BA BE Studies
Our BA/BE Studies package is designed to provide end-to-end support for robust bioavailability and bioequivalence evaluations. This integrated approach ensures that all aspects of your BA/BE studies are managed efficiently, from initial design to final regulatory submission.
