How can RPA be used for clinical trial management?

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    Being a highly regulated and compliance-driven industry, the Pharmaceuticals sector encounters multiple challenges. There are multiple time-consuming, repetitive, and error-prone tasks that are strong candidates for RPA (Robotic Process Automation) implementation. 

    RPA software interfaces with computer applications to perform rule-based, tedious and complex tasks. Automation is executed via dedicated software bots that are programmed to perform specific tasks according to rules and commands previously written in a computer program. 

    The potential for RPA in the Pharma sector is endless since robots automate both front-end and back-end office tasks. Bots help fill out documents and records and are capable of sending automatic notifications, making schedule entries, transferring data between systems, creating documents, as well as for reporting, or ensuring data compliance. Almost 45% of the jobs employees typically perform have the potential of being automated, providing a huge potential for cost reduction and operational efficiency (McKinsey). 

    Role of RPA in clinical trials management

    For many Pharma companies, Randomized Clinical Trials (RCT) is a key area in which various repetitive tasks are automated, leading to significant success rate improvement across different aspects. Designing and settling an RTC includes gathering vast amounts of data and leveraging them efficiently, which is a time-consuming and error-prone process. Here are the key processes that can be seamlessly automated with the help of RPA: 

    1. Trial master file management 

    All clinical trials-related data needs to be registered and stored in TMF, and typically this process is done manually. By leveraging RPA, Pharma companies upload all the information automatically, with proper data structure, and bots further verify and notify if there is any missing data or document. 

    The amount of data to be gathered in TMF is extensive, including details of the laboratories, trial documents, storage records, monitoring visit reports, shipment records, and much more. By combining RPA software with Optical Character Recognition (OCR), which facilitates converting handwritten or printed text into machine-encoded text, the majority of the data in those documents is easily digitized and effectively used. 

    2. Patient matching

    Recruiting patients for trials has become a hassle in many areas of clinical research. The process of creating a patient ecosystem with dynamic inclusion and exclusion is error-prone and time-consuming and is easily optimized with the use of RPA software. Bots are deployed for initial patient matching, where they match the patient data with trial prerequisites, and only take the process further if the results conform, in effect speeding up the recruitment process. 

    3. Pharmacovigilance processing automation

    A recent Ernst & Young report states that a large pharma company typically processes approximately 700,000 AE (Adverse Events) cases annually.

    It’s worth noting that: 

    • More than 50% of PV resources are currently being spent on managing cases that need integrated data varying in structure, quality, and format.
    • The said report by Ernst & Young estimates that automation of these manual steps can help a typical top biopharma company reduce time spent on Pharmacovigilance by 45%, with potential multimillion-dollar annual savings. 

      4. Validation process

    Pharma organizations are taking a step further by integrating RPA bots for complicated processes such as validation. RPA bots validate any clinical process adhering to stringent regulations that are statutory for each separate system supporting the vaccine or drug development. Therefore to prevent error during the validation process, a rule-based robot configuration structure is deployed, ensuring an error-free and efficient process.

    RPA in clinical trials


    Automation is proactively transforming the Pharma sector in multiple areas apart from clinical trials, including product development and real-time monitoring. Many companies are turning to RPA solutions enabling them to boost operational efficiency, productivity, quality, and customer satisfaction.

    Deploying RPA is well worth the returns, especially when a reputed RPA solutions provider like Neebal can provide you unlimited license free bots, helping you save expenses on recurring bot license renewals. Our team of experienced technology experts enables fast solution development and implementation. Would you like to reap the benefits of automation too? We’re here to help! Schedule a call today with one of our top experts to get started! 


    Topics: RPA Solutions, Hyperautomation