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Biostatistics & Data Management

A responsive and flexible approach to data management and biostatistics

A responsive and flexible approach to data management and biostatistics

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Delivering High Quality Data Management & Biostatistics

Be confident in your data for the entire duration of drug development with Medpace’s responsive and flexible approach to data management and biostatistics. Our Data Management and Biostatistics Team of experts undertake each study with your goal in mind, preparing your data for submission.

Data Management: Delivering Data Quality and Integrity

Working closely with Sponsor project teams, the Medpace data management team develops detailed specifications for the collection, organization, validation, and analysis, of clinical trial data that ensure the most cost-effective, secure, and regulatory compliant process. Our extensive knowledge and experience, combined with superior therapeutic and regulatory expertise, provides confidence to the Sponsor. Our robust data collection, validation, and analysis process focuses on precision and efficiency while maintaining the highest levels of data quality and integrity.

Data Management Team Capabilities

The Medpace data management team of experts consists of data managers, data coordinators, clinical database programmers, and clinical data reviewers. Data management services include:

  • Designs case report forms (CRFs) following the CDASH standard
  • Performs double-data entry of CRFs (paper only)
  • Validates all project-specific components of the data management system
  • Reviews clinical data for errors and trends and generates electronic queries
  • Integrates data from external sources to ensure consistency with CRF data
  • Provides medical coding using standardized dictionaries
  • Delivers a clean, analyzable database, adhering to Clinical Data Interchange Standards Consortium (CDISC) standards
  • Reconciles serious adverse events
  • Produces real-time clinical trial metrics
  • Operates seamlessly in multiple EDC platforms, including Medpace’s proprietary system, ClinTrak EDC
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Biostatistics: Delivering Efficient Trials on Time

Our experienced team of biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and reporting accuracy necessary to deliver your trial efficiently and on time. Data analysis is performed using industry-standard SAS® software. 

Biostatistics Team Capabilities

The Medpace biostatics team of experts consists of biostatisticians, statistical analysts, statistical scientists, and clinical database programmers. Biostatistics services include:

  • Protocol development, study design, power calculations, analysis, and endpoint strategies
  • Comprehensive data analysis plans, including detailed descriptions of statistical methodologies and program specifications (TFL shells)
  • Preparation and generation of randomization plans
  • Preparation of customized analysis programs thoroughly tested and validated according to standard procedures
  • PK/PD analyses and modeling
  • Integrated efficacy and safety analysis for regulatory submissions
  • Data Monitoring Committee and Interim Analysis Support
  • Centralized Statistical Monitoring
  • Interpretation of study results and writing support for study reports and manuscripts
  • Adaptive design consultation to help lower development costs and reduce time to market