Success Story

Clinical study data synchronization platform

  • Data engineering
  • Healthcare

Now we are working on a clinical study data synchronization portal requested by a clinical trial company for exporting data from their internal eClinical source system to sponsor platforms. The solution is designed to:

  • automate transfer of patient visit data by synchronizing it across two systems, 
  • and reduce human-made errors by avoiding the need for double data entry, 

which, in its turn, allows

a medical research company

to accelerate clinical research timeline

a pharmaceutical company

to bring new medications to the market faster

Project details

Country:

United States of America

Industry:

Healthcare (clinical trials)

Expertise used:

Data engineering

Team composition:

  • Data Engineer
  • Frontend Developer
  • Project Manager
  • QA Engineer
  • UI/UX Designer

Service provided:

  • Software and data architecture
  • API integration
  • UI/UX design
  • MVP building
  • Manual QA

Project background

The customer is a clinical trial company that conducts research on the effectiveness and safety of study drugs. They collect patient visit details gathered from feedback, questionnaires, and various clinical assessments, which are then manually entered into two data systems for further research, reporting, and trial outcome analysis usage.

 

These data source and target systems are for initial data capture and for comprehensive data management and regulatory reporting, accordingly. The whole process is required by the client’s sponsor, a pharmaceutical company, for regulatory compliance purposes. 

Challenge

However, there is an issue with manual double data entry, which creates inefficiencies in the workflow, results in increased workload, a risk of human error, and delayed data processing. That’s why an automated data synchronization solution is needed to streamline the clinical trial data input process and enhance overall productivity in managing the said data.

Tech stack

Python
AWS

Discovery phase results

  • We have defined the appropriate AWS architecture for data storage and computation; 
  • Infrastructure has been developed to display aggregated visit data, enhancing productivity and debugging capabilities; 
  • Our software design is scalable and allows easy additional providers integration in future.

Solution in progress

We offer the capability to export data automatically to provider’s site along with corresponding information in a few clicks up to 30 minutes of data being available in the data source system as expected. The solution will cover the following functionalities:

  • User authentication: User will be able to securely log in to the system using designated login credentials; 
  • Real-time data reflection: Upon entry of study/visit information in the data source system, it seamlessly reflects within our portal, ensuring real-time data synchronization; 
  • Comprehensive study/visit overview: User has access to a comprehensive list of all studies/visits, accompanied by their respective statuses.
  • Configuration: Study configuration involves entering configuration details directly into the database. Mapping information is added to ensure only necessary data is copied to the data target system; 
  • Automated data copying: Once configuration is done and a “Ready for Export” status for a visit is set, validated data from the data source system is automatically copied to the data target system in a few clicks up to 30 minutes as expected; 
  • Integrity preservation: Visits are copied post-configuration to uphold the integrity of previously synchronized historical data, ensuring data consistency and accuracy.
  • Status tracking: User can conveniently monitor each visit status, which can be categorized as follows: 
    • Exported: Data has been successfully exported. 
    • Failed: The data migration process is not done. 
    • In Progress: Data is transferring to target system. 
    • Not Ready for Export: Data entry is not finished or verified. 
    • Ready for Export: Visit data is entered and validated. 

Clinical trial data for synchronization

  • Vital signs and physical measurements; 
  • Study-specific clinical data; 
  • Screening and consent data; 
  • Patient responses and questionnaires.

Data synchronization portal benefits

Increased efficiency

By eliminating the need for manual data entry, significant time savings and a reduction in human errors are anticipated. This streamlined process allows research teams to focus more on critical tasks related to delivering high-quality research results and improving their effectiveness.

Improved data accuracy

Automation minimizes the risk of data entry errors, ensuring the integrity and accuracy of information transferred between systems. This accuracy is crucial for maintaining the quality and reliability of clinical research data, ultimately leading to more robust study outcomes and conclusions. 

Faster study timelines

Researchers will have access to updated study data, enabling them to make timely decisions and adjustments as needed. Expected data transfer to provider’s sites up to 30 min of availability in the source system expedites the research process, from data collection to analysis.

Better resource utilization

By cutting manual data entry and transfer workload, the client will be able to allocate resources more efficiently. Researchers and coordinators can redirect their efforts towards higher-value tasks, such as patient recruitment, protocol development, and data interpretation. 

Scalability and flexibility

The solution being implemented is designed to accommodate future growth and changes in research needs. It will be possible to integrate new sponsor provider systems, expand study portfolios, and adapt to evolving data management requirements upon the client’s request in the future.

Who can be interested?

Our portal is suitable for clinical research organizations, pharmaceutical companies, healthcare providers, biotech companies, and other medical institutions, seeking to achieve faster and more accurate data management, interoperability, governance, and streamline the overall workflow. 

Learn our clients’ experience

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