Real-World Data for Regulatory Submissions
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.
Contact us to learn more.
