At GenInvo, our motive is to support pharmaceutical companies to bring life changing therapies into the market sooner so that patients can be benefitted as early as possible. As we know, there are several areas in clinical trials that requires tremendous manual efforts, and we are focussing on eradicating these manual efforts by developing the tools that automate these tasks. Clinical & Regulatory Medical writing team spends a lot of time on drafting the documents manually. Authoring Clinical & Regulatory documents requires significant manual efforts, resulting in a time-consuming authoring process.
How about automating the document authoring life cycle for Clinical & Regulatory Medical writing so that medical writers can spend more time on result discussions?
And to add more to this we have introduced AI capabilities!!
We call it your AI enabled Assistant:
A system becomes smarter when artificial intelligence (AI) gets integrated to it. Imagine a system that uses intelligence and work as per your requirement. At GenInvo, to eradicate these manual efforts we developed an intelligent tool – DocGen. It is enabled with AI algorithms and models to support Clinical & Regulatory Documents (typically produced by Regulatory Medical Writing) that will work just like your assistance and that too digitally. DocGen is your AI enabled assistant (already trained on 400+ study documents) that will work under your supervision and will learn from your actions. This AI enabled true assistant helps you to develop the first draft of the document just by uploading the document template(s) and click of the buttons.
- Clinical Study Protocol
- Clinical Study Report (CSR)
- Development Safety Update Report (DSUR)
- Statistical Analysis Plan
- AE Narrative
Note: Technology is not restricted to these documents and any specific template
This AI enable assistant creates contents based on the prompts, that means you just enter keywords or parameters and the content based on the fine-tuned model for the study closest to the inserted prompts will be generated. This will help users to author the draft protocol for conditions or therapeutic areas where there are no reference(s) available. For authoring the document(s) say target document (such as CSR, SAP, etc.) where you need to utilize the information from source documents, DocGen allows you to upload the source documents and corresponding sections from the source documents can be utilized to author the target document(s), here come another advantage of your AI enable assistant that will apply different methods such as copy, copy (past tense) and summarize on source document before utilizing it into target.
It has more to offer; your AI assistant not only insert the table into the document but also interpret the tables for you as well. You can use either standard text or AI generated/suggested text to interpret the table for you.
CSR Authoring Flow:
Protocol Authoring Flow:
By Inderjeet Arora, Principal Data Scientist