Datacise® Technology Platform

Datacise CURATE is a flexible cloud application for the collection and aggregation of clinical data through a variety of data mapping or abstraction methods. This scalable platform simplifies the extract, load, transform (ETL) process to easily ingest structured and unstructured data from any source.

Typical Sponsor use cases for Datacise CURATE include:

• Extract and abstract structured and unstructured data via API (application programming interfaces) or other methods
• Build databases, including data lakes, data warehouses, and other advanced data storage structures (i.e., network graphs)
• Harmonize data through advance pattern matching and the use of  external ontologies, including WHO Drug, MedDRA, CDISC controlled terminology, and other custom dictionaries
• Perform data and image processing in preparation for further analysis or anonymization (DICOM images)

Datacise ANALYZE supports advanced analytical needs for RWD and other data. This includes support of machine learning (ML), natural language processing (NLP) and network graphs. Several state-of-the art data science programming languages are used to analyze data, including Python, R, and  others. ANALYZE is fully integrated with other Datacise applications. Data presentations include advanced visualization features of R Shiny and JavaScript libraries for data-driven documents.

Typical Sponsor use cases for Datacise Explore include:

• Produce simulations and scenario planning
• Perform trend identification across disparate data, including a focus on subsets (cluster analyses)
• Analyze data from unstructured sources, using ML and NLP
• Ability to utilize high-performance computing as necessary for analysis

Datacise EXPLORE provides integrated data visualizations and dashboards to support analysis, review, and speed decision-making. This includes automated data extraction via application programming interfaces (APIs), providing direct access to a wide variety of integrated data and automated file transfers of SAS datasets and other file types. Data refreshes may be scheduled on a regular basis, and users can select between one of the numerous standards, pre-built dashboards or custom data visualizations, depending on need.

Typical Sponsor use cases for Datacise EXPLORE include:

• DSMB (Data Safety Monitoring Boards) and Adjudication meetings including dashboards to augment static tables and listings
• Patient profiles to aid in ongoing safety reviews and assessments
• Dashboards for medical device and wearables data
• In-process data reviews by clinical teams or data managers to ensure data accuracy
• A tool used in the application of risk–based monitoring (RBM) strategies
• Safety surveillance signal detection, using social media and regulatory data sources (i.e., FAERS)

Learn pharmaceutical industry best practices for developing practical data visualizations, tips on identifying and avoiding common pitfalls, interactive dashboards from initial discovery through UAT (User Acceptance Testing) and validation strategies, and the importance of understanding the intended audience and planned use for data visualizations.