Data Management & Biostatistics

Data Management & Biostatistics

Providing precise data capture and management as well as comprehensive statistical analysis, clinical programming, database administration and medical writing of all phases of clinical research, REMS requirements, and outcomes and registries studies

UBC’s Data Management and Biostatistics services bring together technology and therapeutic expertise to provide clinical data management that meets regulatory requirements.

UBC Knows

Sound data is the foundation for successful results. Our experienced data managers, statisticians, programmers, database administrators, and medical writers collaborate closely with our sponsors and with all operations to ensure every step of the project is leading to successful goals.

UBC’s Data Management platform services include:

  • Case report form design and distribution
  • Electronic and paper-based data capture
  • Database design and integration
  • Data entry, review, and query resolution
  • Medical coding with Clinical Review
  • Serious adverse event reconciliation
  • Remote data coordination
  • External data integration
  • Customized status and metric reporting

UBC’s Biostatistics services support study protocols and regulatory submissions, as well as provide statistical methodologies for specific studies and research programs. These services include:

  • Strategic planning and clinical development plans
  • Study design and protocol development
  • Endpoint selection and validation
  • Statistical analysis plans (SAP)
  • Randomization schedules
  • Medical writing
  • Data coordination centers
  • Data monitoring committees (DMC), charter development and DMC administration
  • Custom tables, listings, and figures
  • Legacy database integration
  • Database submission based on CDISC/SDTM guidelines
  • Regulatory submissions – CSRs and updates to NDA/sNDA
  • Publication support

UBC Understands

It’s essential to start early – and to start right. UBC’s industry-leading Data Management & Biostatistics services provide innovative and efficient processes that will ensure exceptional quality and stand up to regulatory and publication rigor.

Commitment to Success

Our technology and processes are adaptable to all forms of research, including but not limited to, registries, REMS, outcomes, clinical trials, and registrational programs. This has led to the successful completion of new and transitioned projects..

Contact Us

Contact us to put our innovative Data Management & Biostatistics services to work for your trial.

 

Thought Leadership

Best Practices for Designing Study Quality Metrics

Keep it Clean: Three Examples of SQM Driving Quality Data

Brochures

UBC Clinical Development Solutions

UBC Solutions