Data Identification and Access: We help our clients identify and access high-quality real-world data sources, including electronic health records, claims data, and patient-generated data.

Data Management and Analysis: We help our clients manage and analyze real-world data using state-of-the-art tools and techniques. Our team of data experts is skilled in data curation, data processing, data analysis, and data visualization.

Study Design and Analysis: We work with our clients to design and execute RWE studies that generate high-quality evidence. Our team of epidemiologists, biostatisticians, and data scientists has extensive experience designing and analyzing real-world studies, including observational studies and randomized controlled trials.

Regulatory Submissions: We help our clients prepare regulatory submissions that incorporate real-world evidence. Our regulatory affairs experts have a deep understanding of the regulatory landscape and can help navigate the complex regulatory requirements for real-world evidence.

Strategic Consulting: We provide strategic consulting services to help our clients integrate RWE into their drug development programs. Our team of experts can help develop RWE strategies, assess the feasibility of real-world studies, and provide guidance on regulatory compliance.

Data Source Identification: We work closely with our clients to understand their specific RWE needs and identify the most appropriate real-world data sources. Our team of experts has extensive knowledge of available data sources, including electronic health records, claims data, and patient-generated data, and can help identify the sources that are best suited to the project.

Data Source Evaluation: Once potential data sources have been identified, we evaluate them for relevance and reliability. Our team uses a rigorous evaluation process that takes into account factors such as data quality, completeness, and consistency to ensure that the selected data sources meet the project’s needs.

Data Source Access: We help our clients access the selected data sources. Our team has extensive experience working with a wide range of real-world data sources and can help navigate the complex data access requirements, including data use agreements, data security, and compliance with relevant regulations.

Data Curation: We work with our clients to ensure that their real-world data is of the highest quality. Our team of experts is skilled in data curation and can help clean and standardize real-world data to ensure that it is accurate, complete, and consistent.

Data Processing: We use state-of-the-art tools and techniques to process real-world data. Our team is skilled in data processing and can help transform raw data into a format that is suitable for analysis.

Data Analysis: We use advanced analytics tools and techniques to analyze real-world data. Our team of epidemiologists, biostatisticians, and data scientists is skilled in data analysis and can help identify trends and patterns in real-world data that can inform drug development and regulatory decision-making.

Data Visualization: We use data visualization tools to present real-world data in a way that is easy to understand and interpret. Our team of experts can help create customized data visualizations that communicate the key insights from real-world data.

Reporting and Interpretation: We provide comprehensive reports that summarize the key findings from real-world data analyses. Our reports are designed to be user-friendly and actionable, providing our clients with the insights they need to make informed decisions.

Study Design: We work closely with our clients to understand their research objectives and design studies that address key scientific and regulatory questions. Our team of experts is skilled in the design of observational studies, including cohort studies, case-control studies, and cross-sectional studies, and can help ensure that the study design is appropriate for the research question and the available real-world data.

Statistical Analysis: We use advanced statistical methods to analyze real-world data and generate high-quality real-world evidence. Our team of biostatisticians is skilled in the use of causal inference methods, including propensity score matching and inverse probability weighting, to address potential biases in observational studies.

Sensitivity Analyses: We perform sensitivity analyses to assess the robustness of our findings and address potential confounding factors. Our team is skilled in the use of sensitivity analyses, including sensitivity to unmeasured confounding and sensitivity to missing data, to ensure that our findings are reliable and informative.

Regulatory Support: We provide regulatory support throughout the RWE generation process. Our team has extensive experience working with regulatory agencies and can help ensure that the RWE generated meets the regulatory requirements for drug development and approval.

Supporting Label Expansion: RWE can be used to support label expansion by providing additional evidence of a drug’s safety and efficacy in new patient populations or indications.

Supplementing Clinical Trial Data: RWE can be used to supplement clinical trial data by providing additional evidence on the long-term safety and effectiveness of a drug.

Addressing Unmet Needs: RWE can be used to address unmet needs by providing evidence on the safety and effectiveness of drugs in patient populations that may not have been adequately represented in clinical trials.

Post-Marketing Surveillance: RWE can be used for post-marketing surveillance by monitoring the safety and effectiveness of drugs in the real world.

RWD/RWE Landscape Assessment: We conduct a comprehensive assessment of the RWD/RWE landscape to help our clients identify relevant data sources, data quality, and potential limitations and biases. This assessment is critical to understanding the potential of RWE to inform drug development and commercialization strategies.

RWD/RWE Strategy Development: We work with our clients to develop a customized RWD/RWE strategy that aligns with their business objectives and complements their clinical development programs. This strategy includes identifying opportunities for RWD/RWE use, developing study protocols, and selecting appropriate analytical methods.

RWD/RWE Study Design: We help our clients design studies that generate high-quality RWE to address specific business needs, including study design, patient selection, and data collection methods.

RWE Analysis and Interpretation: We use advanced analytical techniques to analyze RWE and provide insights into the safety, effectiveness, and value of drugs in real-world settings. We work closely with our clients to interpret these results and translate them into actionable insights that inform business decisions

Regulatory Support: We provide regulatory support to ensure that RWE generated is aligned with regulatory requirements and can be used to support drug development and commercialization.