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Registry of biomedical companies:
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5280 Corporate Drive, Suite C200
Frederick, 21703
United States of America, Maryland
Phone: 301.829.4001
Fax: 301.829.4166
E-Mail:
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Description:
BioStat Solutions, Inc. (BSSI) is a statistical consulting corporation providing services in biomarker statistics, medical & diagnostic device studies and vaccine development. Biomarker Statistics: We offer statistical expertise, from SAP development to reporting, and analytical support, from program creation to validation, on the PGx / biomarker component of studies: - Across Phase I-IV clinical trials as well as exploratory studies
- Across therapeutic areas: Oncology, Diabetes, Neuroscience, Cardiovascular, Autoimmune, Infectious Diseases, Musculoskeletal, and ADME
- Across commercial assay platforms: SNP genotyping (whole-genome or candidate gene), next generation sequencing (NGS), gene expression (chips and qPCR), immunohistochemistry (IHC) and a wide array of protein assays
- And we are experienced and adept at dealing with data from novel assay platforms
Biomarker Discovery & Evaluation - Analysis of Targeted or High‐Dimensional Biological Data
- Empirical Evidence to Support Marketable Differentiation Strategies
Patient Stratification - Identification of Treatment‐Specific Subgroups
- Estimation of Disease Subtypes
Integration of Biomarker Programs with Your Portfolio - Drug Target Identification
- Characterization of Mechanism of Action
- Using Late‐Phase Studies to Inform Early‐Phase Decisions
Medical Countermeasures The development of medical countermeasures (i.e. drugs, devices, or biologics) for use in biodefense presents unique challenges due to the ethical implications of actively exposing humans to known lethal agents and low frequency of natural occurrence limiting the ability to perform efficacy evaluations in observational studies. Alternative solutions such as the use of animal models or surrogate biomarkers must be developed to predict likely clinical benefits in humans, and these new scientific challenges necessitate tailored analytical strategies. Challenges of Gaining Licensure - Engagement with a cross-functional team of experts
- Understanding of the requirements set forth in 21 CFR Parts 314 and 601 (FDA Animal Rule)
- Ability to interact with cross governmental agencies (e.g. FDA, NIAID, DSTL)
- Selection of appropriate design and methods to demonstrate performance
The Complete Analytical Solution - Strategic planning
- Statistical Analysis Plan (SAP) development
- Program creation and validation
- High quality reporting (SARs, regulatory documents, presentations)
- Representation for interactions with collaborators and governmental agencies
Medical Devices Medical devices span many spaces and applications, ranging from radiology (e.g., multi-reader multi-case studies) to pathology (e.g., in vitro companion diagnostics built on IHC data). In this complex landscape, it is critical to understand concepts from pre-analytical development through analytical and clinical validation. Challenges of FDA Approval - Engagement with a cross-functional team of experts
- Understanding the burden of proof for each stage
- Selection of appropriate design and methods to demonstrate performance
The Complete Analytical Solution - Strategic planning
- Statistical Analysis Plan (SAP) development
- Program creation and validation
- High quality reporting (SARs, regulatory documents)
- FDA representation for statistical component
Extensive Experience BSSI specializes in the analytical component of complex premarket notifications (510k) and premarket approvals (PMA): - Medical devices for use in diagnosis or treatment of disease
- In vitro diagnostics (IVD)
- In vitro companion diagnostics
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Last update of this entry: December 10, 2019
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