Biostatistics and Clinical Data Management

The Therapeutics Development Network Coordinating Center Biostatistics and Clinical Data Management team has extensive expertise in the support of both controlled clinical trials and observational studies. We offer full statistical and data management support -- from planning to implementation to reporting.

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Clinical Data Management

Our clinical data management team is made up of seasoned data managers and programmers with cystic fibrosis-specific training who provide quality database setup, data integration, data cleaning, and database lock.

We offer a variety of electronic data management options to best fit each project's needs. These range from simple, cost effective options for observational or small studies to highly complex, sophisticated solutions for large multi-center clinical trials.

The systems and processes we offer are efficient, user-friendly, and designed to ensure the highest-quality data.

Specific data management services include, but are not limited to:

  • Guidance in selection of the most appropriate data management tools
  • Development of study documents, including case report forms, data management plans, and data transfer agreements.
  • Design, implementation, and maintenance of an electronic data capture system for data collection, edit checks, specimen tracking, and study metrics reporting
  • Development and execution of a web-based randomization system
  • Provision of web-based training on electronic data capture and randomization
  • Implementation of a data quality assurance strategy, including ongoing data cleaning and site assistance with online data query resolution
  • Coordination of external (e.g., core laboratory) data transfers and reconciliation
  • Medical coding
  • Programming of interim and final analytic data sets

The TDNCC uses an industry-recognized electronic data capture system and maintains a library of standard CF-specific case report forms, edit checks, derivations, and custom functions that can be reutilized across studies to maximize efficiency in study startup.

Biostatistics and Statistical Programming

Our biostatisticians are accomplished CF researchers with extensive experience in study design, data safety monitoring board (DSMB) support, generation of statistical reports, and manuscript preparation.

Specific statistical services include, but are not limited to:

  • Study design, selection of outcome measures, and sample size estimation
  • Collaboration on writing of the study protocol and other study documents
  • Analysis of specialized, disease-specific outcome measures
  • Development and/or review of statistical analysis plans and DSMB charters
  • Design and programming of tables, figures, and listings for clinical study reports
  • Coordination of DSMB teleconferences and in-person meetings
  • Statistical analyses and programming for interim and final reports
  • Scientific support and statistical outputs for manuscripts and presentations to ensure timely dissemination of study results

Contact Us

For more details or to discuss how we can best support your study, please contact us at

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