Biostatistics and Statistical Programming

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Comprehensive Beginning to End Service

Our Biostatistics and Statistical Programming team provide full-service support through all phases of clinical development and commercialization. Our expert biostatisticians and statistical programmers are located globally and trained in current methods and standards to support the successful execution of your projects.

We leverage our internal Biostatistics Consulting and Biometrics Innovations teams to bring technical expertise and efficiencies to projects of all sizes, ranging from small first-in-human studies to large multinational ones. We also offer a Functional Service Provider (FSP) model for Biostatistics and Statistical Programming Services.

Our experience with the FSP model has been successful across a range of disciplines through long-term partnerships, with multiple dynamic delivery models, in multiple locations with hundreds of Biostatistics FTEs.

 

Biostatistics Consultancy

Our Biostatistics Consulting Group provides support for clinical development plans and/or individual study protocols, including study design, sample size determination, delineation of objectives and endpoints and analysis strategies.

This group of seasoned professionals routinely provides technical support for complex statistical methodology and implementation of adaptive designs, handling of missing data, biosimilar study designs and methodology, regulatory guidance for strategic planning and representation at meetings with global regulatory authorities.

 

Analysis and Reporting 

Our global team provides beginning to end services for a variety of reporting events including: 

  • Clinical study reports
  • Independent Data Monitoring Committees (IDMCs)
  • Interim Analysis
  • Manuscripts and presentations
  • Submissions to Regulatory Authorities (ISS/ISE, post-submission support, rapid response)
  • Periodic Safety Updates

 

All of the analyses and outputs are based on well documented specifications and are validated via independent double programming. Our statisticians collaborate with medical writers and scientific experts to ensure appropriate interpretation of study results. Our services include:

  • Comprehensive statistical analysis plans
  • Randomization schedules produced in accordance with Integrated Response Technology (IRT) requirements
  • Submission-ready datasets and supporting metadata, consistent with industry standards and trends (e.g., Clinical Data Interchange Standards (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM))
  • Blinded and unblinded Tables, Listings and Figures (TLFs)
  • Presentation-ready graphics and tables
  • Stand-Alone Statistical Reports

 

Data Standards and Innovation

We provide thought leadership and operational expertise with data standards and innovation:

  • Platinum CDISC Member with involvement in CDISC Advisory Council and active membership on the CDISC and CFAST standards teams
  • Over 1,000 studies mapped to SDTM and/or ADaM standards
  • Regular training on updates to CDISC standards and requirements provided to team
  • Oversight on studies by CDISC experts, many of whom are authors of the standards themselves
  • Use of a Metadata Repository:
    • Governs the application of CDISC standards across studies
    • Documents and tracks published guidance and sponsor-specific approach to CDISC
    • Streamlines compliance testing
    • Facilitates efficiencies in later studies

 

FSP Model

Our FSP model provides flexible resourcing solutions and a unique and customized approach to each customer, based on project needs (full service provider or staffing), as well as dedicated customer-specific leadership, including executive and operational governance structure to guide the relationship.

In addition, we have an extensive focus on developing our workforce to meet tomorrow’s challenges and experience working in customer systems and SOPs, including integrated training in our learning management system.

Our model also includes comprehensive plans for operations, relationship management, communication, quality and risk mitigation and internal processes and tools in place designed to ensure both speed and quality.

We collaborate extensively across functional teams to ensure customer needs are appropriately identified and supported and provide access to our internal Data Standards Group (DSG) to provide training, integration and support for industry level standards and/or customer standards.