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).
Company Details
- Employees
- 1
- Founded
- -
- Address
- 802 Morning Star Dr, Lakeland,florida 33810,united States
- Industry
- Research Services
- NAICS
-
Scientific Research and Development ServicesResearch and Development in the Physical, Engineering, and Life SciencesResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Website
- http://www.lucynasolutions.com
- Keywords
- Epidemiology, Biostatistics, Health Economics and Outcomes Research, Database Studies, Statistical Analysis, Medicare Claims, MarketScan, Optum, SEER, Real World Evidence, RWE, Protocol, Statistical Analysis Plan, Statistical Modeling, Consulting, Pharmaceuticals, Biotechnology, Medical Device, Data Management, Algorithm Development, Manuscript Preparation, Meta-analysis, Evidence Generation, Study Design, Clinical trials, Quantitative research, Longitudinal, Cohort, Case-control, Survival Analysis, Institutional Review Board, Human subjects.
- HQ
- Lakeland, Florida
Lucyna Questions
Lucyna's website is http://www.lucynasolutions.com
Lucyna's LinkedIn profile is https://www.linkedin.com/company/lucynasolutions
Lucyna has
1 employees.
View email and phone details for 1
employees at Lucyna.
Lucyna's industry is
Research Services
Lucyna's top competitors are
Evalus Ai,
The Litaker Group (Rwe, Population Health),
Clineepi Partners,
Equiclin,
Evidence 360,
Obviohealth,
Polaris Strategic Partners, Inc.,
Datathreads,
Star Biosciences,
Pharmapulse Consultant Group Llc.
Lucyna's categories are Research Services
Lucyna's founding year is 2013
