As medical research becomes more granular and the opportunities to address rare diseases increase, managing clinical trial data is becoming more complex, global, and multidisciplinary. These factors are driving the need for clinical trial management systems and eCRFs that can support global data collection, strong quality assurance processes, and the ability to safely and securely work with many collaborators.
Clinical Trial Management
The Datimbi Platform has been engineered from the core to support medical studies of this nature. Within our platform, one can configure and deploy complex eCRFs within days. Because our platform is GCP validated, the need for study-specific validation is reduced significantly, saving both the time and money required to launch your projects.
Clinical Trial Management Key FeaturesDatimbi provides an end-to-end solution for clinical trial data management, from initial eCRF specification through data validation and study analytics.
- Complex eCRFs can be established with unlimited forms and fields
- Roles and workflow statuses can be customized and used to control user access and privileges at the data field level
- Robust data validation rules, automated calculations, logic-driven workflows and event-driven alerts can all be added to the basic configuration
- A robust randomization model can be customized via parameters and incorporated into workflow processing
- Data quality features include integrated querying, track changes functionality, and a permanent field-level audit trail of changes and actions
- eCRF definitions are linked directly to business intelligence features, including data extracts, analytics, charting, and reporting
BenefitsBecause Datimbi maintains FDA 21 CFR Part 11 compliant software and manages all technical infrastructure and operations, our customers can be up and running with their clinical trial or medical study within days.
- No need to acquire hardware or software: Datimbi manages, maintains and operates the entire technology stack for our customers
- Because we maintain validated software, for trials where validation is important, the additional effort required to validate a specific study is minimized
- Our graphical configuration tools allow very complex data management forms and workflow processes to be set up quickly, either using your trained staff or Datimbi Professional services
- A Robust and flexible security model allows multifaceted collaboration with functionality and data access targeted to specific user groups
- Integrated quality assurance tools, change tracking and monitoring via integrated analytics ensures your study remains on track and data quality will meet the needs of your study
- Data Views, charts, reports and maps based on your eCRF design provide robust analysis tools without the need for external software, while project data extracts allow you to perform comprehensive analysis using your preferred statistical package