Lucyna

Lucyna's two main services areas are biostatistics and real-world data/real-world evidence. Biostatistics: Lucyna provides end-to-end consulting and analytic support to pharmaceutical, biotechnology and medical device companies pursuant to new drug and device applications to FDA and other regulatory bodies around the world. Lucyna can act as either an embedded resource (within your organization) or in a consulting capacity to manage the following aspects of biostatistics within a clinical trial: - Develop study methodologies and write the statistical portions of the study protocol - Write the statistical analysis plan (SAP) and develop tables, listing and figures (TLF) shells - Provide day-to-day biostatistical support, attend regular study meetings and interact with study partners - Organize CDISC-compliant data sets (SDTM, ADaM) - Oversee and/or execute the completion of final biostatistics study deliverables (e.g. completed TLFs) - Co-author the Clinical Study Report (CSR) - Interact with FDA with regards to methodological or data-related questions. Real-World Evidence: Lucyna offers the following services in RWD/RWE to support medical affairs, clinical and commercial teams as follows: - Assists the organization in the development of real-world evidence generation strategies - Support New Drug Applications (NDAs) by assisting with FDA interactions, regulatory advice requests, Health Technology Assessments, and economic modeling - Develop methodological strategies using real-world data (e.g. external control arms) - Perform analyses in a variety of EMR/EHR and registries including MarketScan, Symphony, Optum, Premier, Pharmetrics Plus, TriNetX, CPRD, THIN, JDMC, MDV, Medicare, HCUP, MediSoft, NCI SEER, AHRQ (various), NHANES and many others. - Develop algorithms and predictive models (expected disease burden/probability and health economic) pulling data from multiple sources (often 20+ data sets concurrently).