Clinical data collection for trials is complicated. It is vast and also growing uncontrollably because of the total sum of clinical research, software studies and vendors in clinical research market field. Moreover, a clinical research company should work with different verticals and vendors, including softwares like –

CDM/EDC Systems (Oracle, Inform, RAVE, Open Clinica, EDC etc.), Safety Systems (Argus, ArisG, Clinevo Safety), CTMS Systems (Siebel Clinical, Clintrace, Clinevo CTMS), SAS – Based Systems, Cloud-Based Systems, Legacy Systems, Spreadsheets, Local and Central Lab Systems, EMR/HER Systems, and Regulatory Submission Systems.

In healthcare system, Data Warehouse has been reserved for databases that can be analyzed and integrated queries for patient population. It is assumed as transactional database for optimization of rapid transformation.

Definition of Clinical Data Warehouse

Clinical Data Warehouse or called as Clinical Data Repository is a real-time database that combines data from clinical, safe and non-clinical sources for presenting a combined view.

Clinical Data, Operations Data, Safety Data, Lab Data and other data are kept at one place for review and report making and analyzation. A business intelligence tool when combined with a Data warehouse will make a person knowledgeable about the trial in real-time and further give access to monitoring and make right decisions when needed.

Data Warehouse can be used for – Storage, Review, Standardization, Aggregation, Analysis and Submission. With that being said, it gives a person the authority to – Cross Study Analysis, Data Harmonization, Data reconciliation, Data recording, SDTM Transformation, Data Aggregation and other important business operations.

Why using Data Warehouse?

Database when created by accumulating data which comes from sources inscribed in different types and formats like Oracle, SAS, Text, SQL, XML etc. is required to be stored in safe and secured place, which is Data Warehouse.

Overall, Data Warehouse is about collecting data, changing it and then loading it into a central database. By using Business Intelligence tools, any analytical queries can be solved and predictions can be made. This is always helpful for businesses to grow and take decisions.

Let’s look into the benefits offered by Data Warehouse:

1. Improvement of Data Visibility (Central Platform) – Since Clinical Research organizations process data in different platforms according to their business processes, it is always needed to have an overall view of clinical operations which is safe. So, data should be kept in a place which is compatible. External and internal data should be merged to Data Warehouse and later grouped.

2. Performance Enhancing – Data professionals can use the existing operational database which is a central database, however, it might be degraded in quality and non-usable for operations and reporting. Hence, creating a database tuned and optimized is the solution for reading and operating huge chunks of data.

3. Enhancement of Data Quality – Data professionals at times do not look into the quality of data in the source systems, which often leads to poor data quality. But when Data Warehouse is used, it improves data quality by correcting data during loading or through amending the source problem.

4. Rapid Decision Making and Reporting – Data Warehouse structure gives the end-users flexibility to take interactive analysis on existing data corners. Users can afford to switch among clinical data and operational data, keeping the indicator fixed. This is how users can toss between data and learn about business operations and Key Performance Indicator.

5. Data Regulation – Storing the audits of every clinical Data Warehouse, snapshot of data from different timestamps, and giving version control for the loads and programs, data professionals convince the auditors about data security, and data corrections.