CDISC Services

StatisticaMedica provides high quality CDISC-submission-ready data,
first time and every time

StatisticaMedica is a proven leader in CDISC expertise and implementation. Our team of highly qualified biostatisticians and biostatistical programmers will ensure your data are CDISC-submission-ready, first time and every time. The team is skilled in accredited and advanced levels of CDISC training, thus keeping up-to-date and compliant with the latest CDISC developments.

As an accredited CDISC-registered company, our comprehensive package of CDISC Services significantly improves the overall quality of your submission data. We proactively guide our clients as they adopt CDISC standards, and we provide up-to-date advice on compliance with FDA technical data requirements. StatisticaMedica has experience of standardising various types of raw study data into CDISC SDTM-compliant datasets, thereby maximising data quality. 

Understanding the mindset of the regulatory statisticians

StatisticaMedica interacts directly with the FDA for regulatory submissions on our client’s behalf. Our insight into the regulatory biostatisticians’ requirements results in significantly reduced review times and minimises any FDA questions on the data. We have a proven record of successfully delivering high quality CDISC-compliant data structures that can be easily interpreted, understood, and navigated by the regulatory reviewers.  

Consistently delivering 97% or higher Pinnacle data fitness scores for all FDA submissions

Our comprehensive CDISC package is of the highest regulatory grade, including fully compliant analysis datasets, which are standardised in CDISC SDTM and ADaM formats and labelled with CDISC nomenclature. Both SDTM and ADaM analysis datasets undergo 100% programming validation and validation reports are generated and submitted to our clients.

Proven Experience

  • Successfully working with CDISC standards since it became an FDA requirement in Dec 2016, thereby leading the way towards higher standards of data quality in the industry
  • Delivering 97% or higher Pinnacle data fitness scores for all FDA submissions
  • Effectively converted to both CDISC (SDTM and ADaM) and CDISC-SEND for non-clinical trials
  • A broad range of therapeutic indications covered, including respiratory, neurology, oncology, dermatology and urology
  • Standards and processes in place to adapt to any therapeutic indication

Our CDISC Services include:

  • Study Data Tabulation Model (SDTM) Annotated Case Report Forms
  • SDTM Compliant Datasets (both .sas7bdat and .xpt formats) 
  • Analysis Data Model (ADaM) Compliant Datasets (both .sas7bdat and .xpt formats)
  • Specifications/Mapping Files
  • Integration of Controlled Terminology (CDISC and Sponsor-Defined)
  • Generation of Define.xml
  • Reviewers Guides for both SDTM (cSDRG) and ADaM (cADRG)
  • ADaM Metadata files
  • Pinnacle 21 Enterprise for the electronic validation of CDISC data quality and compliance for regulatory submissions
  • Comprehensive quality control measures
  • CDISC conversion of legacy and ongoing studies
  • Standards for Exchange of Non-Clinical Data (SEND) specific to animal health studies
  • Biostatistical Advisory and Consulting Services