Considerations for Enhancing Trial Efficiency Through Database Design

Get the infographic to better understand the key considerations that must be discussed prior to designing your clinical trial database. These can all impact the speed and efficiency of your clinical program.

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We work smart. Databases are designed with the end-users in mind.

  • For example, we use dynamic search tools to publish fields that are expected based on previous entries – no need to ask site coordinators to know which questions are relevant and which should be skipped – we take the guessing game out of data entry.
  • Similarly, we focus our development of data management documents like the CRF Completion Guidelines to provide thoughtful information to sites instead of a wordy document providing common sense instructions.
  • We think proactively about our downstream stakeholders and how to balance each team members needs throughout the entire data management lifecycle. Our biostatisticians play an active role in not just initial CRF development, but any mid-study changes that may have impacts to programming and subsequent timelines and deliverables.

Explore our clinical data management services.

  • Consulting (strategic program planning, protocol review, EDC selection, etc.)
  • Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
  • Database design, development, and maintenance
  • Data validation programming and testing, inclusive of edit check and manual review specifications
  • Data entry, if applicable
  • Data cleaning and query management
  • Medical coding using WHODrug & MedDRA dictionaries
  • Serious adverse event (SAE) reconciliation
  • Management and integration of local laboratory reference ranges with CRF data
  • Integration, verification and reconciliation of external electronic data
  • EDC selection and end-user training
  • Database lock and archival
  • Database transfer

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