Clinical study data synchronization platform – Human-centered data analytics company (2024)

Success Story

  • Data engineering

  • Healthcare

Clinical study data synchronization platform – Human-centered data analytics company (2)

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

Clinical study data synchronization platform – Human-centered data analytics company (3)

Python

Clinical study data synchronization platform – Human-centered data analytics company (4)

AWS

Discovery phase results

Clinical study data synchronization platform – Human-centered data analytics company (5)

  • 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:

Clinical study data synchronization platform – Human-centered data analytics company (6)

  • 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.

Clinical study data synchronization platform – Human-centered data analytics company (7)

  • 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.

Clinical study data synchronization platform – Human-centered data analytics company (8)

  • 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

Clinical study data synchronization platform – Human-centered data analytics company (9)

  • 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. Expecteddata transfer to provider’s sites up to 30 min of availability in thesource 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

GreenM brings both deep expertise and a highly effective development team to every project they work on. In my time working with GreenM at NRCHealth, they not only delivered every project to spec and on time, but also elevated the level of our whole engineering department with their organizational and architectural best practices.

Alex Gallichotte

BI Department Lead, Fair

Great communication, fantastic partner, really smart about data and health data in particular. Senior Management are some of the best technical people I’ve ever worked with in more than 13 years. They consistently exceed expectations.

Nathan Seaman

VP of Product, Human API

GreenM team has a lot of experience with AWS. They have deployed several solutions. Their knowledge is up to date and I’d highly recommend them to anyone who needs to build BI/analytics leveraging AWS.

Leonid Nekhymchuk

Chief Technical Officer, VisiQuate Inc.

We have worked with Alexey and the team at GreenM on many projects and have consistently been impressed with the quality of their work. They hire very highly skilled individuals and strive to understand not just our immediate needs but the underlying issues and how we can improve the process.

Daniel Sherer

Chief Technical Officer, MedASTUTE Consulting, LLC

I’ve leveraged technical help from GreenM on numerous consulting projects from basic AWS setup and administration to implementing complex design using serverless managed AWS services for rapid development of scalable solutions to clients. GreenM has always delivered on-time and is a great partner to collaborate with.

BJ Choi

SVP Engineering, Quantive Radianse

GreenM is Starschema’s key partner from 2021. GreenM provided its services at a time when the market was looking for the most talented resources who are not only experienced but can also quickly manage the constantly changing technology world. GreenM quickly adapted to the Starschema working culture and high standards, and delivered technical professionals who could blend in easily. GreenM is a highly recommended partner for supporting the growth of any technical company with highly skilled and motivated professionals.

Istvan Kovacs

Delivery Lead, Starschema Ltd.

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Clinical study data synchronization platform – Human-centered data analytics company (2024)

FAQs

Why is data analytics important in clinical trials? ›

Data analytics enables adaptive trial designs where the trial protocol can be adjusted based on interim results. This flexibility can reduce trial duration and costs while increasing the likelihood of detecting treatment effects.

What is the database for clinical data? ›

ClinicalTrials.gov is a registry and results database of privately and publicly funded clinical studies conducted around the world. The resource is provided by the U.S. National Library of Medicine.

What type of data is used in clinical trials? ›

The data collected includes administrative and demographic information, diagnosis, treatment, prescription drugs, laboratory tests, physiologic monitoring data, hospitalization, patient insurance, etc. Individual organizations such as hospitals or health systems may provide access to internal staff.

What does a data analyst do in clinical research? ›

A clinical data analyst is responsible for managing, reviewing, and analyzing health care data and ensuring organizations' data systems adhere to necessary organizational and federal safety standards.

Why is data analytics important in research? ›

Making Informed Conclusions: Data analysis helps researchers draw meaningful and evidence-based conclusions from their research findings. It provides a quantitative basis for making claims and recommendations.

Why is statistical analysis important in clinical trials? ›

As stated, statistical analysis is critical for clinical trials! It allows us to connect the protocol objectives to the analysis described in the Statistical Analysis Plan, so we can quantify the effect of experimental treatments. Conclusions on efficacy, safety and quality of life can be drawn thanks to it.

Why is data analysis important in healthcare research? ›

Data analytics in healthcare helps doctors predict patients' medical interventions and treatments based on their age, medical history, and possible scenarios and outcomes of medication.

Why is data analytics important in pharma? ›

Big data analytics in pharma can help pharmaceutical businesses by leveraging predictive modelling to reduce the cost and speed up clinical trials by optimizing clinical trial designs, patient stratification, site selection identifying and analyzing various data points: such as the participants' demographic and ...

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