Biomedical Statistical Consulting
A contract research organization providing regulatory-focused biostatistics and statistical programming for clinical trials, regulatory submissions, and biomedical research. Services emphasize clinical trial design (including adaptive and Bayesian methods), submission-grade statistical analysis, CDISC-compliant data standards, and regulatory interaction support for medical device and pharmaceutical sponsors.
Industries
Nr. of Employees
small (1-50)
Biomedical Statistical Consulting
Wynnewood, Pennsylvania, United States, North America
Products
Design Clinical Trials
Specializes in designing clinical trials for FDA approval using methods like Bayesian design, adaptive clinical trial design, and Propensity Score Matching.
Analyze Clinical Trials
Conducts analyses of ongoing and completed clinical trials, including routine and complex statistical evaluations.
Regulatory Submission Support
Assists with FDA and other regulatory submissions, including responding to inquiries and representing clients in proceedings.
Statistical Strategy and Guidance
Provides strategic statistical guidance during the design phase of clinical trials to enhance regulatory success.
Publication and Presentation of Results
Presents clinical trial results to regulatory bodies and supports research publications.
Design Clinical Trials
Specializes in designing clinical trials for FDA approval using methods like Bayesian design, adaptive clinical trial design, and Propensity Score Matching.
Analyze Clinical Trials
Conducts analyses of ongoing and completed clinical trials, including routine and complex statistical evaluations.
Regulatory Submission Support
Assists with FDA and other regulatory submissions, including responding to inquiries and representing clients in proceedings.
Statistical Strategy and Guidance
Provides strategic statistical guidance during the design phase of clinical trials to enhance regulatory success.
Publication and Presentation of Results
Presents clinical trial results to regulatory bodies and supports research publications.
Services
Clinical trial design and protocol/statistical analysis plan development
Design of regulatory-ready protocols, statistical analysis plans, sample size and power analyses, mock TLFs, and operational feasibility input to align designs with regulatory expectations.
Submission-grade statistical analysis and reporting
Validated statistical analyses, interim analyses, sensitivity and subgroup assessments, and production of clinical study reports and TLFs prepared for regulatory submission.
Statistical programming and CDISC mapping
Transformation of EDC data to analysis datasets, CDISC SDTM and ADaM mapping, Define-XML production, and automated TLF generation using SAS/R.
Regulatory meeting preparation and representation
Preparation of materials for pre-submission meetings, responses to FDA inquiries, and representation of sponsors in regulatory proceedings and panel meetings.
Database design and data governance consulting
CRF review, specification of data flow and entry procedures, data screening plan development, and data governance policies aligned with regulatory expectations.
Methodological research and publication support
Collaborative data analysis and co-authorship for peer-reviewed publications and white papers supporting clinical and methodological advances.
Clinical trial design and protocol/statistical analysis plan development
Design of regulatory-ready protocols, statistical analysis plans, sample size and power analyses, mock TLFs, and operational feasibility input to align designs with regulatory expectations.
Submission-grade statistical analysis and reporting
Validated statistical analyses, interim analyses, sensitivity and subgroup assessments, and production of clinical study reports and TLFs prepared for regulatory submission.
Statistical programming and CDISC mapping
Transformation of EDC data to analysis datasets, CDISC SDTM and ADaM mapping, Define-XML production, and automated TLF generation using SAS/R.
Regulatory meeting preparation and representation
Preparation of materials for pre-submission meetings, responses to FDA inquiries, and representation of sponsors in regulatory proceedings and panel meetings.
Database design and data governance consulting
CRF review, specification of data flow and entry procedures, data screening plan development, and data governance policies aligned with regulatory expectations.
Methodological research and publication support
Collaborative data analysis and co-authorship for peer-reviewed publications and white papers supporting clinical and methodological advances.
Expertise Areas
- Regulatory biostatistics and submission support
- Clinical trial design and adaptive/Bayesian methods
- Statistical programming and CDISC data standards
- Submission-grade statistical analysis and report generation
Key Technologies
- SAS programming
- R programming
- Bayesian statistical methods
- Adaptive clinical trial methodology