CERobs Consulting
CERobs Consulting specializes in providing individualized consulting services in study design, methods, and improvement of patient-centered outcomes research, real world evidence (RWE), and regulatory strategy. Their mission is to deliver real-world scientific solutions that matter, emphasizing core values such as joy, efficiency, excellence, and person-centeredness. They have a collaborative model with extensive experience in pharmaceutical and medical device industries, focusing on epidemiology, outcomes research, and regulatory support to help clients develop and implement effective evidence generation strategies.
Industries
Nr. of Employees
small (1-50)
Products
Pragmatic Randomized Clinical Trials (book)
Edited volume on design and conduct of pragmatic randomized clinical trials using primary data collection and electronic health records; reference for trialists and methodologists.
Pragmatic Randomized Clinical Trials (book)
Edited volume on design and conduct of pragmatic randomized clinical trials using primary data collection and electronic health records; reference for trialists and methodologists.
Services
End-to-end consulting for design and execution of RWE studies using claims, EHR, registries, and primary data collection to support clinical, regulatory, and payer needs.
Systematic review and validation of RWE data sources, processes, and documentation to assess usability for regulatory submissions and decision-making.
Targeted, comprehensive, or systematic literature reviews with optional formal bias assessment and meta-analysis to inform clinical and regulatory decisions.
Design, qualitative validation, and measurement-property evaluation of clinical outcome assessments and patient-reported outcome measures for use in trials and labeling.
Strategic planning to align evidence generation with regulatory and payer requirements, including risk mitigation, global planning, and tracking of regulatory guidance.
Statistical design, SAP development, programming/coding, and analysis for clinical trials and observational studies including adaptive designs and advanced causal methods.
End-to-end consulting for design and execution of RWE studies using claims, EHR, registries, and primary data collection to support clinical, regulatory, and payer needs.
Systematic review and validation of RWE data sources, processes, and documentation to assess usability for regulatory submissions and decision-making.
Targeted, comprehensive, or systematic literature reviews with optional formal bias assessment and meta-analysis to inform clinical and regulatory decisions.
Design, qualitative validation, and measurement-property evaluation of clinical outcome assessments and patient-reported outcome measures for use in trials and labeling.
Strategic planning to align evidence generation with regulatory and payer requirements, including risk mitigation, global planning, and tracking of regulatory guidance.
Statistical design, SAP development, programming/coding, and analysis for clinical trials and observational studies including adaptive designs and advanced causal methods.
Expertise Areas
- Real-world evidence generation
- Pharmacoepidemiology and observational research
- Clinical outcome assessment (COA/PRO) development and validation
- Pragmatic and randomized clinical trial design
Key Technologies
- Electronic health record analysis
- Administrative claims data analysis
- Registry-based studies
- Patient-reported outcome measures
News & Updates
An event scheduled for September 18, 2035, in New York, NY, focusing on women's issues.
An event scheduled for September 18, 2035, in New York, NY, aimed at discussing barriers in the field.
A book edited by Cynthia Girman and Mary Beth Ritchey on using primary data collection and electronic health records in clinical trials.
A list of publications contributed by CERobs consultants on topics like real world data, evidence synthesis, and clinical trial design.
An event scheduled for September 18, 2035, in New York, NY, focusing on women's issues.
An event scheduled for September 18, 2035, in New York, NY, aimed at discussing barriers in the field.
A book edited by Cynthia Girman and Mary Beth Ritchey on using primary data collection and electronic health records in clinical trials.
A list of publications contributed by CERobs consultants on topics like real world data, evidence synthesis, and clinical trial design.