TradeCraft Clinical Research
TradeCraft Clinical Research is a life sciences consulting firm specializing in statistical programming and biostatistics services for life sciences organizations. They focus on delivering high-quality, compliant data packages for regulatory submissions, including CDISC standards, to expedite product approval processes. With a team of experienced experts, they provide analysis, visualization, compliance, and submission solutions, supporting clients through complex clinical trials and regulatory requirements.
Industries
Nr. of Employees
small (1-50)
TradeCraft Clinical Research
Wayne, Pennsylvania, United States, North America
Products
Proprietary clinical data visualization and analytics platform
A web-based analytics platform that ingests CDISC-standardized data to produce interactive visualizations, audit trails to raw data, and module-based analyses for safety, labs, exposures, and other clinical domains.
Proprietary clinical data visualization and analytics platform
A web-based analytics platform that ingests CDISC-standardized data to produce interactive visualizations, audit trails to raw data, and module-based analyses for safety, labs, exposures, and other clinical domains.
Services
Analysis database setup, program development, diagnostic data generation, automated reporting, interim analysis output, integrated summaries, and regulatory submission outputs.
Statistical design and planning support including protocol development input, power/sample size estimation, SAP development, modeling, reporting, and support for regulatory responses.
A secure, web-based interactive visualization and analytics platform that uses standardized clinical data to provide real-time views, audit trails back to raw data, and modules for demographics, disposition, adverse events, labs, vital signs, and more.
Comprehensive reviews of study data assets, SDTM/ADaM specifications, validation reports, and data reviewer documentation to identify gaps and prioritize remediation for submission readiness.
Oversight of external vendors, project coordination, and provision of staffed biostatistics and programming teams to act as an extension of sponsor teams.
Analysis database setup, program development, diagnostic data generation, automated reporting, interim analysis output, integrated summaries, and regulatory submission outputs.
Statistical design and planning support including protocol development input, power/sample size estimation, SAP development, modeling, reporting, and support for regulatory responses.
A secure, web-based interactive visualization and analytics platform that uses standardized clinical data to provide real-time views, audit trails back to raw data, and modules for demographics, disposition, adverse events, labs, vital signs, and more.
Comprehensive reviews of study data assets, SDTM/ADaM specifications, validation reports, and data reviewer documentation to identify gaps and prioritize remediation for submission readiness.
Oversight of external vendors, project coordination, and provision of staffed biostatistics and programming teams to act as an extension of sponsor teams.
Expertise Areas
- Statistical programming for clinical trials
- Biostatistics and clinical study design
- CDISC standards implementation and submission data packages
- Clinical data visualization and interactive analytics
Key Technologies
- R
- R Shiny
- SAS
- Python
News & Updates
Mike Willis, CEO of TradeCraft, was recognized for his leadership and impact in the life sciences industry.
A strategic alliance to enhance regulatory submission services, combining expertise in data packages and submission management.
Expansion into the European market through a partnership with Green Room, offering CDISC data services across Europe.
TradeCraft will have teams attending the Clinical Trials and Strategic Summit in San Francisco, CA.
An article discussing the importance and application of R programming in clinical trial data analysis.
An article on the adoption of CDISC standards in clinical research.
Mike Willis, CEO of TradeCraft, was recognized for his leadership and impact in the life sciences industry.
A strategic alliance to enhance regulatory submission services, combining expertise in data packages and submission management.
Expansion into the European market through a partnership with Green Room, offering CDISC data services across Europe.
TradeCraft will have teams attending the Clinical Trials and Strategic Summit in San Francisco, CA.
An article discussing the importance and application of R programming in clinical trial data analysis.
An article on the adoption of CDISC standards in clinical research.