CDISC: Ensuring Regulatory Compliance and Standardization We specialize in CDISC (Clinical Data Interchange Standards Consortium) standards, offering a comprehensive range of services to streamline your data management processes. Our expertise includes:

  • Creation of SDTM aCRF annotation: We meticulously annotate your data collection instruments, ensuring compliance with SDTM (Study Data Tabulation Model) standards.
  • Creation of SDTM and ADaM Specification: We develop precise specifications for SDTM and ADaM datasets, ensuring accuracy and consistency throughout the data conversion process.
  • Development and Validation of SDTM and ADaM datasets: Leveraging our extensive programming experience, we develop and validate datasets that adhere to SDTM and ADaM standards, providing you with reliable and analysis-ready data.
  • Conversion of legacy data to SDTM and ADaM Standards: We facilitate the seamless transition of your legacy data into CDISC-compliant formats, enabling better data integration and interoperability.

TLF (Tables, Listings, and Figures): Presenting Your Data with Impact Our skilled team excels in the development and validation of Tables, Listings, and Figures based on your statistical analysis plan (SAP). We transform complex data into clear, visually appealing outputs, allowing you to effectively communicate study results and insights.

CRT Package/ Data Exchange: Facilitating Efficient Data Sharing We facilitate data exchange through the creation of essential deliverables, including SDTM Define.XML, ADaM Define.XML, Clinical Study Data Reviewer’s Guide (cSDRG), and Analysis Data Reviewer’s Guide (ADRG). By ensuring accurate and standardized data representation, we support seamless collaboration with regulatory agencies and data monitoring committees.

Integrated Studies: Consolidating Data for Informed Decision-Making Our expertise extends to integrated studies, where we compile and analyze data from multiple sources to generate comprehensive Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. These reports empower you to make informed decisions and support regulatory submissions confidently.

Safety Report: Ensuring Patient Well-being We prioritize patient safety by providing expert support in generating high-quality safety reports. Our comprehensive approach and attention to detail help you comply with regulatory requirements and maintain the utmost vigilance in monitoring study participants’ well-being.