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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. 

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