Finding a trusted partner for statistical programming can be difficult. Programmers play a critical role in drug development and are essential collaborators who help teams understand their data. R&D teams often need specialized expertise or additional resources to augment their programming team.
The TradeCraft team becomes a natural extension of our client R&D teams, offering specialized expertise when it is needed. We bring a wealth of experience to the table including programming, advanced analytics, clinical development, CDISC data standards and governance, and the complete data lifecycle. We have experience in Phase I-IV clinical trials and are ready to help you meet your development milestones and goals.
CDISC Standards in the Clinical Research Process
Model for Planning
Model for Data
Model for Tabulations
of Study Data
CDISC Compliant Submission Deliverables
Study data standards help teams share clinical and nonclinical research data. Sponsors implement these standards to share data with CROs, development partners, and agency reviewers. Health authorities use them to facilitate regulatory reviews of nonclinical and clinical trial data. The standards enable automations that improve the efficiency of regulatory reviews.
The US FDA has mandated electronic data standards for nonclinical and clinical data to be submitted to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) for Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologic License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs). These standards include:
CDISC Standard for Exchange of Nonclinical Data (SEND) for nonclinical data
CDISC Study Data Tabulation Model (SDTM) for clinical data
CDISC Analysis Data Model (ADaM) for analysis of clinical data
CDISC Case Report Tabulation Data Definition Specification (Define-XML) for the metadata that accompanies SEND, SDTM, and ADaM datasets
Today, these standards are also required by Japan’s PMDA and preferred by China’s NMPA. Regulatory submissions represent years of research and millions of dollars worth of time and effort. Timelines are often tight, but compliance cannot be sacrificed for speed. Non-compliance can result in a technical rejection of the regulatory application. This can delay the start of new trials, pause agency review processes, and potentially risk product launch dates.
Most large and mid-size pharmaceutical and biotech companies and CROs have embraced the use of data standards and are employing them throughout the organization. As early-stage companies move their products through development, the standards facilitate due diligence activities with potential partners or acquirers, enabling quicker reviews and creating greater value for all stakeholders.
TradeCraft understands the value of your data. We have extensive practical knowledge and experience creating CDISC compliant submission deliverables. We work closely with customer teams to ensure that all data deliverables reflect the hard work, effort, and investment that R&D organizations have put into their data.
We produce regulatory submission data deliverables from INDs to NDAs, including:
ADaM Analysis Datasets
SDTM/ADAM QA Review of case report tabulation packages
Define.pdf and Define.xml
Study Data Reviewer’s Guide (SDRG)
Study Data Standardization Plan (SDSP)
Analysis Data Reviewer’s Guide
Tables, Listings, and Figures
Bioresearch Monitoring (BIMO) data package including:
• Subject-Level Data Line Listings by Clinical Site
o Individual Subject Listings by Site
• Summary Level Clinical Site Datasets
o Data Reviewer’s Guide
We also offer CDISC mapping and conversion services for legacy data.
Statistical Programming Consulting
Throughout the product development lifecycle, R&D teams need to review and analyze study data at different stages and for different purposes. Depending on their role, they may require different views of data.
Sponsor teams also work closely with independent data monitoring committees (DMC) who are responsible for monitoring interim trial results to ensure the safety of trial participants, the effectiveness of the research product, and proper study conduct.
TradeCraft can set up the analysis database, generate diagnostic data for centralized monitoring, and create output for interim analyses.
Clinical Study Reports
Data Monitoring Committee Meetings
TradeCraft is pleased to offer adjacent services to ensure the success of our client teams.
Clinical Data Asset Review & Report
Statistical results confirmation – an independent review of statistical output
Functional Service Provider (FSP)
Complete Biostatistics Staffing
SOP/Process Review & Optimization
SAS, Python and R program, and R Shiny
SAS reporting macros
Learn more about TradeCraft Clinical and how we can support your compliant data efforts.