The client, despite being an emerging pharma company in the country, had a reasonably vast customer base because of its high quality, efficient, top-notch drugs produced every year. Ongoing COVID-19 outbreak not only meant a higher increase in its demand and productivity, but also meant managing operations and workloads with a solution which not only streamlines its drug development and marketing process, but also takes care of quality, compliance, and cost.
Maintaining a robust knowledge base was necessary for the company to support its engineering and product development process. However, a humongous number of documents and articles were scattered across multiple File Shares and SharePoint sites, making it nearly impossible and cumbersome to access and extract relevant information from them. Moreover, each department had their own content search standards, information structure, and metadata. This inadequate search capabilities and lack of access to relevant content not only disturbed the synergy for product development, but also led to unnecessary duplication of experiments.
The company needed a single unified knowledge repository where consistent information based on standard template would be found and easily retrieved through predefined set of taxonomy and business rules. Also, the company was facing following challenges in its clinical trial operations.
- The company handled more than 60k adverse event cases per year, managing and reporting these cases to the sales department was manual and therefore error prone and tedious.
- Managing a single master data repository or Trial Master File (TMF) required manual entry of data and files in the TMF structures, limiting the chances of drawing useful and relevant insights.
- Recruiting patients for assessing impacts of clinical trials, using dynamic inclusion and exclusion criteria, was difficult to process due to large amount of manual intervention involved.
To summarize, the entire process of drug development and drug approval was being undermined by the manually processed error prone clinical trial operations.
With the obligation to build safe and efficacious products for consumers around the globe, the client wanted to automate their menial, repetitive tasks and allow its employees to shift attention towards higher value tasks. Owing to its experience and expertise in process automation services, AQL was soon approached by the client to analyze their existing manual process and craft an automated solution.
We started the process by carefully examining critical areas for automation and customizations. Our approach involved testing, documenting, and validating RPA bots in all relevant phases. Our expert developers and testers were soon successful in developing a knowledge base portal using Power Apps and Power Automate wherein an automated workflow was designed using RPA for the following:
- Extract data from various integrated data sources and associate each incoming content with relevant product in development.
- Assign predefined taxonomy to each set of content and classify files accordingly using semantic classification.
- Search for redundant content across the platform and clean, dedupe and remediate any kind of errors.
Additionally, the clinical trial process was automated with the following measures:
- RPA bots were designed to extract adverse drug reaction information from physicians and send real time reports to sales representatives.
- A flow was created to extract data from various sources, analyze, process, cleanse it, and then add the files onto TMF structure.
- Another flow was designed to extract key information from various documents in patient’s portal, collate crucial proof to determine eligibility as per inclusion and exclusion criteria and send the results for final assessment.
AQL’s services was not only limited to replace the traditional manual tasks with a low code RPA solution but also ensured that the solution was easily deployable and scalable to adopt to changes in ever evolving pharma industry.
Implementing RPA in the drug development and approval journey underpinned the company’s efforts to reduce extra expenses, workforce utility, and improve operational efficiency. A single source of truth for entire manufacturing technical knowledge meant less time spend on searching and less or no wastage of resources. Also, with RPA optimizing the clinical trial process, time spent on pharma co-vigilance was reduced by 55%. By automating the data entry stages, about 80% time was reduced, eventually saving millions of dollars.
Further, the company is in discussions with AQL to expand the automation project to various other areas wherein complex processing along with implementing advance technologies like AI, ML, and CI are needed.
“AQL’s unprecedent support and expertise has helped us fulfill our aim of being the most trusted therapeutic providers across the entire country. Not only our immediate issues are addressed, but our product success rate has increased from 45% to 85% in short span of time.”
Director, IT Department