Pharmaceutical companies conducting clinical trials are dealing with multiple challenges resulting from industry specifics - highly regulated and compliance-driven. Trials are time-consuming and generate enormous amounts of data, which have to be collected, analyzed, and stored in a way assuring easy access. This article will help you to understand the potential of RPA and its benefits for streamlining clinical trials, with examples of processes that can be automated and potential benefits.
Companies use RPA software to support employees by carrying out repetitive, rule-based tasks, which are time-consuming and error-prone. Automation is carried out through dedicated software bots that have been programmed to perform specific tasks according to rules and commands previously written in a computer program.
According to a McKinsey study, almost 45% of the jobs we do can be automated, which provides a huge potential for cost reduction and effectiveness improvement for pharmaceutical companies.
RPA software can be used to automate both front-office and back-office tasks, such as:
The use of RPA software simplifies and streamlines processes that have to be conducted during clinical trials, resulting in speeding up tasks and improving results accuracy. Even regulatory agencies, such as FDA, recognized the benefits of automation and the use of new technologies, encouraging companies to implement them into their strategy, and supporting them by issuing appropriate industry guidelines.
The main benefits of using RPA for clinical trials are:
Knowing amounts that are at stake, it is easier to imagine the potential for savings that can be achieved with each improvement and automation. As estimated in research by Aylin Sertkaya, published in PubMed.gov, the cost of each phase varies, depending on the therapeutic area, spreading between $ 1.4 million for phase 1 of endocrine drugs, up to $52.9 million for phase 3 in case of pain and anesthesia drugs:
Pharmaceutical companies that benefit the most from the implementation of Robotic Process Automation are the ones that start with creating an optimal strategy. It should not only focus on identifying the most promising tasks but also assure that employees are aware of the goal and potential benefits of the automation, not only for the company but also for them.
To learn more on what are elements of such strategy, what are the steps and how long does it take to implement RPA read our step-by-step guide to robotic process automation delivery.
RPA software, because of its potential to solve the problem of systems interoperability can be used in all steps of clinical trials, not only to optimize trial management and data collection, analysis, and sharing but also patient matching and processing PV cases.
The complexity and scale of clinical trials (and amount of data resulting) are well shown in the table from ResearchGate.net article on “Drugs, Devices, and the FDA”, by Gail Van Norman:
Looking in detail at all phases of clinical trials we can identify use cases in each, which can be optimized with the use of Robotic Process Automation software, including:
This is by no means an exhaustive list of all areas that could be in part automated, but the complexity and repetitiveness of tasks that can be identified in them can serve as an example of the potential of RPA.
If you have specific questions about the possible implementation of RPA in your company you can benefit from a free 30 minutes consultation, during which we can help you identify your needs and pick the right technology to match your challenges.
In the rest of this article, we will go into detail about each of the areas that we identified and try to show how companies could use bots to boost productivity and reduce costs.
Regulatory affairs (RA) scientists are responsible for overseeing the process of getting a drug through regulators' review and approval and onto the market. Depending on the size and scale of the company business, assuring that all regulatory requirements are being met is challenging and time-consuming.
Automation can be used to streamline regulatory management, helping RA professionals in:
Not only monitoring or communication but also data importing and format unification can be improved with proper use of Robotic Process Automation, effecting in reducing the time needed to complete many manual tasks.
Experts agree that proper site management is an essential element of clinical trial execution, improving the chance of trial success. Properly selected, prepared, and monitored sites are better in the effective recruitment, treatment, and retaining of subjects, with regard to regulatory compliance.
Many tasks related to contracting, payments, and monitoring are manual in nature and can be easily automated with RPA, not only on basic ones, such as notifications and deadline tracking, invoice collection, and even automated payments but also on a more detailed level, including:
According to Pharmaceutical-technology.com recruiting patients on to trials has become a bottleneck in many areas of clinical research. The procedure of creating a patient population with dynamic inclusion and exclusion is time-consuming, and can easily be optimized with the use of robotic process automation software. Bots can be used for initial patient matching, before interaction with employees will be required, in effect speeding up the recruitment process.
An illustration of automated patient-trial matching was included in article by Junyi Gao, available through Cornel University site:
With an increasing number of trials conducted with patients enrolling using the internet, the amount of data to verify grows and requires more automated solutions, especially when combined with growing interest in DTP (direct-to-patient) drug distribution strategies in trials.
DTP distribution negates patients’ needs to travel to the clinical site. While it can potentially contribute to improved patient recruitment and retention, it requires high level of automation within the supply chain of a trial drug, to mitigate risks and drive better outcomes.
Logistics involved in clinical trials are highly complex, requiring extreme flexibility and support of new technology to meet extensive regulatory requirements and remain efficient and cost-effective.
Logistical challenges which have to be overcome are only increasing, especially with new drug tracking regulations worldwide (an example of the complexity of such requirements can be the Drug Supply Chain Security Act (DSCSA) in the US).
With an increasing number of clinical trials also complexity grows:
A good example of a company embracing automation can be Marken, a subsidiary of UPS, shipping drugs and biological materials at all temperature ranges to investigator sites, depots, and directly to patients’ homes.
The company uses advanced tracking technology with GPS for real-time tracking of a package’s location and monitoring of any exposure to temperature variations, vibration, light, and shock - with automated notifications in case of breaching border conditions (for example by alerting airlines to move packages that were not maintained at the correct temperature).
All activities related to clinical trials have to be registered and stored in TMF, and in many cases, those data are entered manually. With proper use of RPA, all of that information can be uploaded automatically, and with proper data structure, bots can be also used to verify which data are missing.
The list of information that should be gathered in TMF is extensive, including:
By combining RPA software (for example UiPath) with optical character recognition (OCR), which allows converting print or handwritten text into machine-encoded text, most of the data in those documents can be easily digitized and effectively used.
According to an Ernst & Young report, a large pharma company processes approximately 700,000 adverse events (AE) cases annually.
It’s worth noting that:
By implementing RPA software data collection and management can be radically improved, increasing effectiveness and guaranteeing significant cost reduction.
As mentioned, Robotic Process Automation has enormous potential to be applied to multiple processes carried out by any company, from simple tasks (generating an automatic response) to more complex activities. Such flexibility allows this software to be implemented in basically any department within the company, where repetitive tasks are performed.
Most frequently described use cases of RPA include:
Administration, tax, and finance department:
Human resources department:
Financial and accounting operations are especially good candidates for automation, as they are largely rule-based, very manual, and virtually always carried out within IT systems. This is confirmed by the 2019 McKinsey report, pointing out various business areas and their potential for business process automation:
In this article, we focused on a small part of the automation strategy, which is the use of RPA software for streamlining manual and error-prone processes, which can be identified and linked to all phases of clinical trials.
It’s worth noting that it would be impossible to find today a pharmaceutical company that did not implement any sort of electronic document workflow. But with all the changes that are happening within the industry, it is essential to ensure that such document circulation systems still properly serve their purposes, which are most of all:
Many companies have implemented an electronic document workflow without proper thought. That is why we can find even today companies that struggle with outlandish and intricate processes executed in an even more outlandish way.
To learn more about what a company should consider to assure that automation is being implemented and used in the most effective way, we invite you to read our in-depth guide on How to streamline and automate processes and workflows in your company.
If you are wondering how to start or improve the implementation of automation and digitization of processes and document flow in your company, get in touch with one of our consultants. You can book free 30 minutes consultation with us and we will help you identify your needs and pick the right technology to match your challenges.