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
BSC® Biostatistics and FDA Submission Consulting Services
Specialized biostatistical expertise and regulatory strategy consulting to navigate complex FDA submissions, ensuring project success and timely approval.
BSC® Advance
A strategic and innovative statistical consulting solution by Biomedical Statistical Consulting® that goes beyond standard CROs with smarter, future-ready methods for novel medical device and pharmaceutical regulatory challenges.
BSC® Solutions - Breaking New Ground
A specialized regulatory and statistical consulting service for novel medical devices that do not fit standard regulatory molds, offering innovative endpoints, performance goals, and regulatory pathways.
Biostatistics and FDA Submissions Consulting Services
Specialized biostatistics and regulatory strategy consulting services for FDA submissions, including clinical trial design, statistical analysis plans, data management, and complete regulatory submission packages (510(k), PMA, NDA).
BSC® Design
Statistical and regulatory consulting services supporting trial design including protocol development, sample size and power analyses, endpoint selection, SAP development, and pre-submission meeting support.
BSC® Analyze
Submission-grade statistical analysis service delivering precision, auditability, and regulatory confidence for medical device and pharmaceutical trials.
BSC® Biostatistics and FDA Submission Consulting Services
Specialized biostatistical expertise and regulatory strategy consulting to navigate complex FDA submissions, ensuring project success and timely approval.
BSC® Advance
A strategic and innovative statistical consulting solution by Biomedical Statistical Consulting® that goes beyond standard CROs with smarter, future-ready methods for novel medical device and pharmaceutical regulatory challenges.
BSC® Solutions - Breaking New Ground
A specialized regulatory and statistical consulting service for novel medical devices that do not fit standard regulatory molds, offering innovative endpoints, performance goals, and regulatory pathways.
Biostatistics and FDA Submissions Consulting Services
Specialized biostatistics and regulatory strategy consulting services for FDA submissions, including clinical trial design, statistical analysis plans, data management, and complete regulatory submission packages (510(k), PMA, NDA).
BSC® Design
Statistical and regulatory consulting services supporting trial design including protocol development, sample size and power analyses, endpoint selection, SAP development, and pre-submission meeting support.
BSC® Analyze
Submission-grade statistical analysis service delivering precision, auditability, and regulatory confidence for medical device and pharmaceutical trials.
Services
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.
Validated statistical analyses, interim analyses, sensitivity and subgroup assessments, and production of clinical study reports and TLFs prepared for regulatory submission.
Transformation of EDC data to analysis datasets, CDISC SDTM and ADaM mapping, Define-XML production, and automated TLF generation using SAS/R.
Preparation of materials for pre-submission meetings, responses to FDA inquiries, and representation of sponsors in regulatory proceedings and panel meetings.
CRF review, specification of data flow and entry procedures, data screening plan development, and data governance policies aligned with regulatory expectations.
Collaborative data analysis and co-authorship for peer-reviewed publications and white papers supporting clinical and methodological advances.
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.
Validated statistical analyses, interim analyses, sensitivity and subgroup assessments, and production of clinical study reports and TLFs prepared for regulatory submission.
Transformation of EDC data to analysis datasets, CDISC SDTM and ADaM mapping, Define-XML production, and automated TLF generation using SAS/R.
Preparation of materials for pre-submission meetings, responses to FDA inquiries, and representation of sponsors in regulatory proceedings and panel meetings.
CRF review, specification of data flow and entry procedures, data screening plan development, and data governance policies aligned with regulatory expectations.
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
News & Updates
Overview of CDISC standards (SDTM, ADaM, CDASH, ODM) and their role in regulatory submissions and data interoperability.
Summary of the International Conference on Pharmacoepidemiology with emphasis on medical device epidemiology and real-world evidence.
Article discussing major CROs and trends in clinical research operations and technology.
Overview of CDISC standards (SDTM, ADaM, CDASH, ODM) and their role in regulatory submissions and data interoperability.
Summary of the International Conference on Pharmacoepidemiology with emphasis on medical device epidemiology and real-world evidence.
Article discussing major CROs and trends in clinical research operations and technology.