Real-World Data for Regulatory Submissions

This service is offered in collaboration with:

Real-World Data (RWD) is increasingly used in regulatory submissions within the healthcare and pharmaceutical industries. This data comes from various sources, including registries, electronic health records, and insurance claims, each with its own collection methods, data models, and standards.Ensuring data lineage from source to submission is essential for regulatory approval. We provide a full range of services to support this process, from consultancy to data standardization and analysis.

Our Services

We help establish complete data lineage from Real-World Data sources to clinical trial submissions, including:

  • Data source requirements – evaluating study objectives and required elements for real-world data source selection
  • Data source assessment – evaluating quality, relevance, and representativeness
  • Standardization & mapping – aligning RWD with industry standards (SDTM, OMOP, FHIR, USDM, etc.)
  • Data analysis & reporting – preparing RWD for regulatory use
  • Traceability & documentation – ensuring compliance and transparency

    • Our Expertise

    Our team of consultants, programmers, and statisticians brings:

    • Deep knowledge of Real-World Data and clinical trial processes
    • Experience in industry standards and study mapping
    • Secure data environments for compliance and confidentiality
    • Active involvement in Real-World Evidence communities

    We are well-equipped to support the integration of Real-World Data into regulatory submissions.

    Do you want to find out more about our services?


    Then get in touch with Melanie Schopp through the button below or at melanie.schopp@ocs-consulting.com.