BIOSTATISTICS SERVICES

Biostatisticians help answer critical research questions. Perhaps most importantly, they aid clinical research teams in the collection, analysis, presentation, and interpretation of study data to determine the safety and efficacy of products in clinical trials.

But many R&D teams struggle to find the right biostatistician to support their project or program. They may not need a full-time biostatistician or may need specialized expertise. Therapeutic area expertise, experience creating a statistical analysis plan (SAP) for a clinical trial, or familiarity with due diligence processes are requirements that narrow the field of potential candidates. Recruiting and retaining talent takes time and resources that some R&D teams can’t afford.

The highly skilled TradeCraft Biostatistics team supports clinical trials from study design and protocol development to analysis and reporting. Clients lean on our expertise to ensure that protocol integrity is reflected in the design of the trial, that all data collection tools are aligned, and that data quality is prioritized throughout the process. Combining these practices improves the data life cycle and offers the greatest value to clinical research teams.

Our precision, speed, and flexibility maintain the integrity of a clinical trial while improving communication among clinical research team members. 

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Speed

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Precision

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Flexibility

Functional Service Provider (FSP)

 

We work with trial teams on the development of case report forms and database specifications to optimize trial activities. We review the CRFs to ensure data collection endpoints are aligned with trial objectives.

Our team is involved in every step of clinical research including trial design, protocol development, monitoring and data management, data analysis and reporting.

  • Clinical development planning

  • Provide input into power/ sample size estimation

  • Assist in protocol development with a focus on the statistical method section

  • Develop Statistical Analysis Plan (SAP) with mock tables

  • Perform interim analyses or coordinate with Independent Data Monitoring Committees (IDMC)

  • Create data deliverables to support Annual / Periodic Reporting

  • Conduct statistical modeling / exploratory analyses

  • Statistical reporting and publications

  • Support finalization of clinical study reports

  • Planning and development of ISS / ISE / Meta-Analysis

  • Conduct due diligence

  • Support statistical components of responses to agency inquiries

Learn more about TradeCraft Clinical and how we can support your compliant data efforts.