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Healthcare AI/ Pharmacovigilance/ Smart Data ENtry

Streamlining Pharmacovigilance Data Entry with AI and Machine Learning

Design and development of a user-centered solution that automates the complex manual data entry process in pharmacovigilance, reducing the time and effort required for resources to file adverse events into the pharmaceutical database.


Overview

Pharmacovigilance is a globally recognized and regulated process that tracks the adverse effects of any drug. The manual data entry process is time-consuming and requires expertise and experience due to the complexity of diseases and events. This project aims to leverage AI and machine learning to automate the data entry process, ensuring accuracy, efficiency, and consistency.

My Role

Research, UX Design, Prototyping, Visual Design

The Team

2 Designers, 1 Design Lead

10+ Engineers

Timeline

8 Months

PROCESS TRANSFORMATION

NEW DESIGNS

Project Goals

Automate Data Entry

Utilize AI and machine learning to automate the extraction, classification, and entry of adverse event data from source documents.

Improve Data Quality

Ensure data accuracy and consistency by leveraging design systems and real-time validation.

Increase Efficiency

Reduce manual effort and time spent on data entry, allowing resources to focus on high-value tasks.

DESIGN GOAL

How Might We Streamline Pharmacovigilance Data Entry with AI and Machine Learning?

Existing Process

NEW PROCESS

Existing Process

Recieve

Users receive document from external portal

Upload

Uploads document in

PV First

Digitize

System digitizes into structured document and autofills the fields

Review

Users review cases using assisted controls

Submit

Submit Document

Manual

Automated

Upload Document

System Performs Data Entry

Add Feedback for wrong highlights

Accordions to

reduce scrolling

Understanding the Users & Process Flows

We conducted qualitative user research to gain a deeper understanding of user roles, backgrounds, responsibilities, and behaviors.


This involved conducting in-depth interviews with 10+ users individually to gather insights into their experiences and perspectives. Additionally, we shadowed users to observe their interactions and behaviors in real-life scenarios. By mapping out the process flows and understanding the "as-is" journey, we identified problem areas and pain points that informed our design decisions

HIGHLIGHTS & PAIN POINTS

If quality of the documents are not good, it makes my job stressful in reading the data leading to inaccurate cases

H

Hansa Gupta

Case Processor, 28 Years

Going through each and every document individually is a time taking process

Sri vidhya

Case Processor, 29 Years

Our case processing happens on multiple softwares. Procuremnet happens in one, processing happens in one and submission on another

A

Akhilesh

Case Processor, 28 Years

Brainstorming & IDEATION

Visual Strategy & DESIGN LIBRARY

TESTing and ITERATION

DESIGN PROCESS

Snippets from the User Interview

Identifying Strategic Scope

To simplify the data entry process and enhance its efficiency, we brainstormed with the Tech Team and discussed how we can leverage AI and machine learning to automate and streamline the process. Here are some potential strategies:

Automated Data Extraction:

Utilize AI-powered data extraction tools to automatically extract relevant information from source documents, reducing manual effort and increasing accuracy.

Smart Data Classification

classify and categorize data, ensuring that it is accurately and consistently labeled, and reducing the need for manual intervention.

Document Standardisation

To make it easier for users to understand and navigate the forms, reducing confusion and errors.

Predictive Form Completion

Leverage machine learning models to predict and complete missing data, reducing the need for manual data entry and improving data accuracy.

Before the finalhandoff, we tested certain critical functionalities of the product with the actual users in a moderated environment. The goal of the test was to check the efficiency and effectiveness of the product.

 

A sample of 10 people were identified and the prototype was tested with them.Several interesting observations came out of the test which were then prioritised with the business as per their complexity.

 

Although the accuracy of the system was not that great due to lack of data, but the overall effciency of the product improved considerably. We created a detailed report and submitted it to the product team

Highlights System

Extracted Data

Ability to filter system

highlighted data

Filters extracted & required fields

Switch Between Original Document & Structured Document

Case Processing Screen

Multi Layered Data

organisation for optimum decluttering

Shows density of data in the

document

Highlights key information as

required by users