Consultancy Services
ClinLine is a consultancy service provider in the area of clinical data lineage and real-world data utilization for regulatory submission purposes. This may include (but is not limited to):
- Study design tooling and digital data flow processes,
- Data modelling, use cases and solution design,
- Source data validation and governance,
- Optimizing efficiency in data mapping and modelling,
- Efficient data submission strategies,
- Data mapping and/or validation services,
- Real-world data and selection strategies.
ClinLine works with a number of highly experienced USDM experts, real-world data experts, data mapping experts, and programmers who can be utilized for consultancy purposes as needed.
ClinLine consultant profiles
- Consultancy strengths: USDM implementation, data lineage, data modelling and architecture, data source selection, data quality & validation.
- 8 years of experience with direct source RWD access and utilization as RWD R&D manager
- USDM technical expert, trainer and digital data flow use case expert
- Education: Biomedical Sciences, statistics, programming and management.
- Skills: SQL, SAS, Python, Visual Basic, Delphi, JSONata; Project Management, Lean, TOGAF, Management drives; Standards: FHIR, OMOP, CDISC: SDTM, ADAM, USDM
- Consultancy strengths: Data strategy, Data quality & validation, Data platforms, FDA submission process, Regulatory analytics, Data Mapping, Data analysis
- Education: Computer Science, Medical Biology
- Sr in HEOR, Epidemiology, and Market Access
- Skills: SQL, SAS, Python, R, Java; Amazon Web Services (AWS); Project Management, Study Design, Reporting and publishing, statistical modelling
- Standards: HL7 FHIR; CDISC SDTM, ADaM, Define.XML, OMOP, USDM
- Strengths: Data Model compliance validation
- Skills: detail oriented, relevant standard(s), relevant data standard and regulatory requirements, SAS, R, Python, SQL, Programming in SAS
- CDISC standards, OMOP, FHIR, USDM, SDTM, ADAM, OMOP, FHIR, vendor data formats