Synthetic Patient Data in Clinical Trials: Why it’s important to have meaningful synthetic data. 

It is time consuming and difficult to manually generate the test data to support Clinical Programming (CP)/Biostatistics and statistical processes and the differences in the quality and coverage of only limited type of scenario in test data causes the delay in the quality check processes.

To overcome these challenges, we should have the capability to generate the artificial data automatically with the use of synthetic data generation software that can be utilized to support these processes. Data which is not collected from real world event(s) and generated artificially is referred as synthetic data. 

Just Synthetic Data or should it be Meaningful Synthetic Data? 

Does it make difference? 


To fulfil the requirements to support Clinical Programming (CP)/Biostatistics and statistical processes, the availability of synthetic data which is not meaningful won’t be sufficient.

To cover all the scenarios of the real clinical trial data there are several points those needs to be considered and taken care of.

Such as, links between the forms/datasets i.e. concomitant medication (CM) given for an adverse even (AE) is not matching or not entered; results of pregnancy test should be available for females not males, etc. There are several such instances where synthetic data which is not meaningful will fail to serve the purpose. 

On the other hand, meaningful synthetic data covers all the scenarios required to boost Clinical Programming (CP)/programming/statistical processes. 

How can GENINVO help you generate “meaningful” synthetic data?  

GENINVO’s Datalution™ is all in one solution for generating meaningful synthetic data for testing electronic data capture, edit checks, data management (as part of UAT Process), programming, and statistical setup activities for Dry Run (mapping/transformation, TLFs & visualization ) and more. 

Advantages of using Datalution™

  • Easy to use user interface. 
  • Generate Real like synthetic data for upcoming or ongoing clinical trials integrated with patient journey. 
  • Zero risk of de-identifying patients 
  • Allow stake holders to have data at right time and increase the trial efficiency by performing data operations quickly without hick-ups. 
More Blogs

The Importance of Automation in Clinical Trials 

Introduction  Clinical trials are the backbone of medical research and innovation. They play a pivotal role in advancing healthcare, developing…
Read More

Quick Look at Software Testing

Introduction Software testing plays a vital part of the software development lifecycle that ensures the quality, reliability, and performance of…
Read More

Ensuring GDPR Compliance with Advanced Data Anonymization Solutions

Introduction In an increasingly interconnected world, where every digital interaction leaves a trace, safeguarding personal data has become a paramount…
Read More

Managing Product Development Amidst Regulatory Changes Landscape 

Introduction  In today’s fast-paced business environment, product development is a critical aspect of staying competitive and meeting consumer demands. However,…
Read More

Overview of Clinical Data Sharing and Data Anonymization

Need for Data Sharing For biomedical research, Clinical trials are essential components as they lay down the foundation for the…
Read More

Synthetic Patient Data in Clinical Trials: Why it’s important to have meaningful synthetic data. 

It is time consuming and difficult to manually generate the test data to support Clinical Programming (CP)/Biostatistics and statistical processes…
Read More

EMA policy 0070 Relaunch in September 2023 – What you should need to know! 

EMA Policy 0070 is to be relaunched in September 2023. This was announced by the European Medicines Agency during a…
Read More

Automation within Medical Writing

What does medical writing function do? Medical writing is a highly specialized field that involves content writing and clinical research…
Read More

Synthetic Data Vs Real Data 

There has been an increase in interest in synthetic data over the past few years for various applications such as…
Read More

Data Protection 

The impact of globalization on privacy of identity is growing. The fact that more and more Data Protection, comprising data…
Read More

ISMS Implementation 

Every technology-driven business process is exposed to security and privacy threats. Modern technologies are capable of preventing cybersecurity attacks, but these aren’t enough,…
Read More

What is Password Protection?

Damanjeet Singh – Technical Lead- IT & Infrastructure Passwords provide the first line of defense against unauthorized access to your…
Read More

What is KUBERNETES (k8s)? 

Manish Anupam – Manager-IT & Database In this digital era, every project needs to be built in less time with…
Read More


Gurjeet Dhaunsi – Analyst- QA/CSV ISO (International Organization of Standardization) is non-profit organization which is setup with a goal to…
Read More

Innovation in Medical Writing

Innovation’ denotes new, better, more effective ways of solving problems. An innovation must be something truly new or at least…
Read More

Project Management to support GENINVO Innovation efforts

Given the growth of the pharmaceutical segment, the industry needs to become increasingly better at managing pharmaceutical projects for more…
Read More

Regulatory Bodies in Life Sciences

Regulatory bodies (or regulatory agencies) in Life Sciences as we have come to know them have been around since the…
Read More

Contact Us​

Skip to content