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Clinical Data Management Services

Clinical Data Management Services

We rely on innovative technology and hands-on experience to manage every step of your clinical trial. Ancla’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, regulatory compliant and analysis-ready. We leverage the power of Software Services to bring you a customized EDC and Paper Base.
To meet your specific clinical data management challenges and budget parameters. To guarantee the integrity and accuracy of study data, our clinical data management team strictly adheres to established and proven internal quality processes. For more information, please review below Ancla Clinical Data Management services:

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We provide the full range of Clinical Data Management Services:

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. We specialize in delivering both to minimize issues during the course of your trial:

  • eCRF design and implementation
  • eCRF Annotation
  • Automated Edit Check (System and Program)
  • Database design (variable formats, code lists, logical flow, etc.)
  • Database User Acceptance Testing and implementation
  • Clinical 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 Ancla, we are data-centric and provide unparalleled passion for ensuring that your data is complete, accurate and consistent:

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

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