Data Management

Consistent, high quality data is a critical component of every clinical study, and we are very experienced in identifying and solving the many challenges related to quality clinical data management.

DSP’s Data Management team has an average of 10 years of experience and is a proud Industry Partner of the Society for Clinical Data Management (SCDM). It is DSP’s continuing commitment to attract and retain the highest quality clinical data management leaders and follow processes based on Good Clinical Data Management Practices (GCDMP).

 

 

 

DSP’s approach is always forward thinking so that we can proactively identify and address potential data and protocol issues that may cause problems further into a study. This ensures strategic allocation of time and resources, on-time and on-budget database lock, and data that is clean, regulation-compliant, and analysis-ready.

We leverage the power of Software-as-a-Service (SaaS) to bring you a customized, rapid EDC solution to meet your specific data management challenges, other project needs, and budget parameters. To ensure the integrity and accuracy of study data, our data management team strictly adheres to established and proven internal quality processes.

DSP Data Management services include:

Study Startup

It is critical to have high quality data collection tools and databases in place for a clinical trial. It is also vital to have comprehensive planning documentation that adds tremendous value to the trial. At DSP, we specialize in delivering both to minimize issues during the course of your trial:

  • eCRF design and implementation.
  • Database design (variable formats, codelists, logical flow, etc.).
  • Database User Acceptance Testing and implementation.
  • Data Management Plan creation (which includes references to all planning and database documents).
  • Vital planning and database document development, such as External Data Specifications, Data Extract Specifications (including SDTM format), Validation Specifications, eCRF Completion Guidelines, and Medical Coding Guidelines.

Study Conduct

While the study startup stage focuses on planning and design, the conduct stage is driven by execution. At DSP, we are data-centric and provide unparalleled passion for ensuring that your data are complete, accurate, and consistent:

  • Data cleaning, including query management, report/listings review, and data quality audits.
  • External data loading and reconciliation.
  • SAE reconciliation.
  • Medical coding via MedDRA and WHO Drug.
  • Key Performance Metrics (KPI) generation and analysis.

Study Closeout

The study closeout stage is often a stressful time for all involved with tight timelines and even tighter budget to achieve database lock. At DSP, we are experts during this stage in ensuring full execution of all planning documents and delivering a database that is clean, analysis-ready, and actionable:

  • Final data cleaning and reconciliation.
  • Database lock and PI signature management.
  • Data archiving and storage.
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