Clinical Data Management

We rely on innovative technology and hands-on experience to manage every step of your clinical trial. Eclipse’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-as-a-Service (SaaS) to bring you a customized InForm™ 6 EDC

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 visit our Knowledge Central for Key Industry Guidance.

Eclipse 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
  • 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 eclipse, 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
  • 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 constraints to achieve database lock. The eclipse team are experts in the closeout stage, 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

Our suite of clinical technology solutions will provide more accurate real-time data collection, standardization, aggregation, analysis, reporting and risk and operations management, maximizing the performance and cost effectiveness of your clinical trials.  Eclipse’s electronic data capture (EDC) and clinical trial management systems (CTMS) support a Risk Based Monitoring approach. With our help, you’ll better analyze and understand data and make quicker, more informed decisions. Are you ready to get started? Contact us today.

So What’s Next?

There are many factors in choosing a new Clinical Data Management team and we talked about quite a few of them here. If you would like to explore your Clinical Data Management options further please schedule a consultation with one of our Clinical Data Management experts.

Contact us today to learn more.

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