GENINVO Blogs

Journey from developer to innovator for generating clinical trial artifacts

By Amit Gupta, Technical Lead- Software Development

My name is Amit Gupta, and currently I am working as a full stack developer and innovator at GenInvo for generating clinical trial artifacts with overall 10+ years of extensive IT experience.  Interest in technology from the school days made me into the bachelor’s in computer science and engineering. I am firm believer that technology can impact lives at a level and scale that has never been realized in the history of mankind. The idea that something I create can impact people across the world right now or in the future is what drives my passion for Technology. I am passionate about technology because it’s about building better tools to ease people’s life.  

I started my professional journey as software developer with Tata Consultancy Services. During my time there I learnt multiple technologies and project in different domain. My experience with multiple technologies majorly revolves around Java and its frameworks, tools and services along with other popular backend and frontend technologies like Python, PHP, Angular, Different types of Databases, Mobile Application Development, Internet of Things, and others. 

Having interest in solving real world problems, learning new technologies and tools made me to start exploring the Artificial Intelligence and Machine Learning technologies. I started spending time to understand how smart system works and, how we can build new tools that can help us in solving problems dynamically. I got the understanding that with technology continues to evolve, the journey into the realm of AI/ML promises not only personal and professional growth but also provide the opportunity to shape the future of how we live, work, and interact with world. 

Saying all these my interest in working with mind blowing AI/ML technologies got increased and I started liking all these. This goes with famous quote from W.Clement stone   

When you discover your mission, you will feel its demand. It will fill you with enthusiasm and a burning desire to get to work on it.” 

 Back in 2020, I got an exciting opportunity to work with one of the most innovative software companies in the field of Clinical Research, i.e. GenInvo whose mission fascinated me that state  

Our vision is the digitalization of the Clinical Research industry.

GenInvo is a product-based company that develops innovative software products for clinical research & life sciences. We have multiple products that help in automating different functions across different stage of the clinical trials using AI/ML technologies. Currently conducting clinical trials by pharma companies is a very time consuming, complex, and high money-oriented process.  These trials involve multiple phases and many kinds of artifacts generations such as Protocols, CRFs, SAP, TLF, Standard-compliant datasets (such as SDTM & ADAM), Metadata and other reports. 

I started developing innovative tools in GenInvo which help in generating these artifacts using technologies like python, R, AI/ML, and others. While working on these we generated multiple algorithms to implement the automations in the clinical trials process. We are working with common goal to make innovation in clinical trial artifacts generation to accelerate various stages of clinical trials that ultimately speed up the entire process and benefit patients with new drug availability. 

Being an innovator, I am continuously working toward developing many new tools with the help of AI/ML models and algorithm that can generate automate generation of more clinical trials artifacts in less time with least manual intervention. 

Conclusion 

In conclusion, the journey from a software developer to become an innovator is a dynamic odyssey marked by continue learning, collaboration, and the pursuit of innovation. As we navigate through the ever-evolving landscape of technology, let us remember that the challenges we face are opportunities for growth. To all who are in this genre or going to come, just keep in mind that you must make your hands open to accept all knowledge coming and think out the box. 

Below mentioned are the innovative tool that we developed at GenInvo, visit our products to explore and get the insights. 

Shadow 

Shadow is a leader in automating data and document de-identification and anonymization technology. Our team of Life Sciences and software development professionals built it with a commitment to producing innovative and long-standing solutions. 

DocQC 

DocQC is a tool for automation of Quality Control (QC) checks that have historically required multiple, time-consuming cycles of manual review. Checks of various complexities are programmed leveraging cutting‒edge technologies. DocQC enables your Medical Writers to maintain their focus on the science, analyses, and presentation of results. 

ApoGI 

ApoGI is an integrated, automation platform that leverages AI and ML, focusing on standards and metadata management to streamline processes and the generation of artifacts, typically associated with the clinical study lifecycle. 

ApoGI Data Transformation 

The SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are standards for human clinical trials (research) data tables and non-clinical data tables submitted by researchers to health authorities. It aligns with the specification developed by the Federation of Clinical Data Exchange Standards (CDISC). ApoGI is AI and meta-data driven designed for automation of end-to-end drug development process. 

DocGen 

DocGen – a document generation software for healthcare industry that revolutionizes the way life science companies generate and review standard documents. 

More Blogs

Importance and examples of usage of Data Anonymization in Healthcare & Other sectors

Data anonymization plays a critical role in healthcare to protect patient privacy while allowing for the analysis and sharing of…
Read More

Data Anonymization and HIPAA Compliance: Protecting Health Information Privacy

Data anonymization plays a crucial role in protecting the privacy of sensitive health information and ensuring compliance with regulations such…
Read More

Automation of Unstructured Clinical Data: A collaboration of automation and Medical Writers

In the field of healthcare, clinical data plays a crucial role in patient care, research, and decision-making. However, a significant…
Read More

Quality Control of the Methods and Procedures of Clinical Study

Methodology section of the Clinical Study Report (CSR) provides a detailed description of the methods and procedures used to conduct…
Read More

Automated Quality Control: Get the best out of your Clinical Study Report Review 

What are Clinical Study Reports?  Clinical study reports (CSRs) are critical documents that summarize the results and findings of clinical…
Read More

Clinical Study Results: Quality Control on study findings and outcomes

Clinical Study Reports, or the CSRs, are comprehensive documents providing detailed information about the design, methodology, results, and analysis of…
Read More

Big Save on Time > 60%, A case Study: DocQC™ Tested on 25 Studies.

Medical Writers have provenly spent a lot of time historically, in reviewing the Clinical Study Reports. Clinical Study Reports, or…
Read More

Data Anonymization in the Era of Artificial Intelligence: Balancing Privacy and Innovation

Data anonymization plays a crucial role in balancing privacy and innovation in the era of artificial intelligence (AI). As AI…
Read More

Automated Quality Control: Get the best out of your Clinical Study Report Review

What are Clinical Study Reports?  Clinical study reports (CSRs) are critical documents that summarize the results and findings of clinical…
Read More

Data Redaction: Safeguarding Sensitive Information in an Era of Data Sharing

Data redaction is a technique used to safeguard sensitive information in an era of data sharing. It involves selectively removing…
Read More

10 Best Data Anonymization Tools and Techniques to Protect Sensitive Information

Data anonymization plays a critical role in protecting privacy and complying with data protection regulations. Choosing the right data anonymization…
Read More

Building a Strong Foundation: Robust Metadata Repository (MDR) Framework for Automated Standard Compliant Data Mapping

Pharmaceutical and biotechnology companies operate within a constantly evolving regulatory landscape, where adherence to standards set by organizations like the…
Read More

Digitalization of Medical Writing: Balancing AI and Rule-based algorithms with Human Supervision in Medical Writing QC

What is Digitalization of Medical Writing?  The digitalization of medical writing refers to using digital technologies and tools to create,…
Read More

The Rise of Differential Privacy: Ensuring Privacy in the Age of Big Data

The rise of differential privacy is a significant development in the field of data privacy, especially in the age of…
Read More

Role of Intelligent Automation: How Intelligent Automation transforms the Clinical Study Document Review in Real Time

Clinical Study Reports play a critical role in assessing the safety and efficacy of new medical treatments. Review of these…
Read More

Automation on Clinical Study Report: Improve the Speed and Efficiency of document review. 

Clinical Study Report (CSRs) are critical documents that summarize the findings and results of clinical trials. These reports require a…
Read More

Digitalization of Quality Control in Medical Writing: Advantages Digitalization brings for the critical aspects of Quality Control

Quality control in medical writing is a critical aspect of ensuring the accuracy, clarity, and reliability of medical documents. It…
Read More

Importance of “Table, Listing and Figures” Automation in Clinical Trials

Tables, Listings, and Figures (TLFs) help to analyse and summarize datasets of a clinical study into an easily readable format….
Read More

The “What” and “Why” of Clinical Data Anonymization

Clinical data anonymization is the process of transforming or modifying sensitive clinical-related information in a way that protects the privacy…
Read More

Medical Writer’s True AI Enabled Assistant

At GenInvo, our motive is to support pharmaceutical companies to bring life changing therapies into the market sooner so that…
Read More

Contact Us​

Skip to content