Data Standards

Rigorous data analysis and technology are at the heart of everything we do. PharmaStat consultants use carefully designed metadata to specify, derive, validate, and document data conversions and analyses. Our mission is made considerably easier by the widespread adoption of CDISC global data standards by the pharmaceutical and medical device development industries. We know how to make the standards work for us and we can make them work for you, whether to support in-sourced operations, out-sourced operations, or a regulatory submission.

PharmaStat and CDISC

The FDA is working closely with CDISC to specify an end-to-end standards-based package for submission of data and metadata to the FDA.  FDA published its intention to require the Study Data Tabulation Model (SDTM) for data submissions at the Proposed Rule Stage in the Federal Register.

PharmaStat LLC is CDISC Registered Solution Provider. Our consultants are at the forefront of the movement to design and implement data standards for drug development. We founded the Bay Area and Washington DC Implementation Networks and we have volunteered on several development teams with CDISC.

Implementation of data standards

Collectively, the consultants at PharmaStat LLC specialize in the design and implementation of rigorously-defined, standard-based statistical computing environments and clinical data pathways. Our services, including strategic consulting, training, and software development, are built around a thorough understanding of the SDTM and other CDISC standards.

Although we are only a few consultants, we’ve been involved in more SDTM implementations than almost anyone in the industry. Some CDISC implementations are on the path to a submission. Strict conformance to the standards is critical for these projects, and we use a variety of methods to achieve a reviewable CDISC submission. Other CDISC implementations are designed to support outsourcing. We help you interpret and manage the SDTM, define.xml, and ODM models to specify the deliverables produced by multiple outsourcing partners in a way that fits into your operations.

Conversion and Integration of Legacy Data

At PharmaStat, we work with both proprietary and marketed tools such as SAS and WebSDM to convert and evaluate data mapped to the SDTM. Our rigorous validation process looks at the structure and content of SDTM data to ensure that it conforms to the specification and yields meaningful and analyzable information to medical reviewers and biostatisticians. Whether we perform the legacy data conversion or provide technical coordination and oversight, we take charge of the process to ensure that collected data is preserved, that derived data is traceable to its origins, and that controlled terminology is used appropriately.