Sanjay Koshatwar, Executive Vice President, Pharma & Life Sciences, Incedo, highlights the potential of robotic process automation to usher efficiency, profits and regulatory control in the pharma industry
The pharmaceutical industry is going through a tough phase as research costs have hit the roof over the last few years, along with increasing regulatory controls. The healthcare industry has observed a multi fold rise in the cost of life-saving drugs, which puts pharma firms in a tough spot. The recent drug price hearing held at US this month publicly shamed drug companies, adding to the tremendous pressure to bring new drugs into the market profitably.
Challenges along the traditional path
Currently, pharma firms are looking for innovative ways to close the gap between growing R&D costs and profits, while facing the challenge of rising regulatory control, testing, securing approval and bringing new drugs to the market efficiently.
So far, most changes which aimed at reducing costs and increasing efficiency was done through centralisation and standardisation of processes. However, in some cases, standardisation can also mean compromising on the organisation’s capability to react quickly to changes. Choosing between the lesser of the evils isn’t an option and presents a challenge for most enterprises today.
Most of the established pharma firms are re-evaluating their business models as well as their operations. These requirements involve too many man hours to handle continuous and repetitive manual processes as many of the business processes associated with clinical trials, clinical data management are outsourced.
The pharma business is known to be a process-oriented industry. There are many standard operating procedures like Master Data Management, Drug safety reporting and clinical data management.
For about 20 years, pharma firms have been outsourcing these processes to lower cost countries and it helped in curbing costs for a while. However, cost arbitrage which came from outsourcing doesn’t hold a competitive edge any more, thus compelling the industry to use automation. Besides, many clinical processes in practice today are still people intensive. This means a high volume of staff get busy in ensuring efficiency, profits and regulatory control when it can be done by machines in a shorter time.
Advent of RPA
Replacing the human element with Robotic Process Automation (RPA) can be a potential game changer. Many of us have heard the term RPA but industry didn’t fully understand its potential. It is sometimes misinterpreted due to the absence of robots. Rather, RPA software is a powerful tool which is capable of performing manual, time-consuming, repetitive tasks efficiently at lower costs, when compared to other automation solutions available in the market today.
For those who are not familiar with RPA, it is an application of technology which allows employees to configure a ‘robot’, or a computer software which can capture data from existing applications within the organisation to process a transaction, operate with the data, generate an appropriate response and communicate with other digital systems – all this without any human intervention. This technology is transforming the way we work traditionally, and it is set to change the way we know work processes over the decade.
Enterprises must constantly evolve to keep efficiency high and new opportunities flowing. RPA can bring down the need for people based processes significantly, and it can improve speed, accuracy and compliance – all this at a reduced cost to the pharma firm. It helps in saving costs by eliminating manual labour and reducing the wait time.
The potential applicability of RPA is widespread and spans across industries such as BFSI, retail, pharma and other data intensive sectors. Since RPA is relevant to almost every process associated with clinical research, pharma firms are prime candidates for RPA since the solution is ideally suited to any process that can be defined and consistently executed with minimal variation.
RPA in pharma
With RPA, the pharma firm applies digital robots to perform repetitive tasks in a high volume which earlier robbed the organisation of human hours. RPA can ensure consistency in data entry, quality control and regulatory control and is suitable for any domain or any function where there is a repetitive process. For instance today we manually validate NPI/SLN numbers of HCP/HCO for those records where MDM could not match, it takes approximately 15 to 30 minutes. Meanwhile, a robot can be trained to open an email, attachments on the email such as exception report in Excel, validate information, request any detail that is missing by navigating to relevant websites, fill the data and send an email to the manager. All this happens in less than a minute and can be designed to run parallelly.
How does RPA help?
All businesses are beginning to recognise the importance of RPA. Mainly, they see that implementing RPA in pharma firms offers an advantage of speed, auto audit trail and improved accuracy, eliminating human errors. Every process is required to be traceable and accountable; and while designing automation, we have experienced process optimisation in most cases. RPA bots can be deployed in parallel to scale up the surge almost instantaneously using cloud. One of the major advantages of RPA projects is that it does not initiate long IT integration project. Implementation of RPA projects can be led by business operation. In our experience, most of these projects can be delivered in 8-10 weeks and benefit from RPA.
A key advantage of RPA over other automation technologies is its drag-and-drop functionality. Unlike traditional automation tools, RPA solutions can be easily implemented and it can be effortlessly integrated with existing systems. It also eliminates the need for programming or coding. Consequently, RPA can be implemented in a matter of days.
Potential areas for application
RPA adoption is currently in its nascent stage within the pharma industry. Broadly, pharma firms can benefit from RPA in the following areas.
- Clinical development: RPA can cut processing time for clinical data management, site management, site payment processing, clinical data quality check and relevant actions, master data management, data stewardship etc. RPA is primarily helpful with email processes, validation of an employee, approval-integration with HR, contract management system etc.
- Commercial operations: RPA can be applied into functions like sales force effectiveness, Aggregate Spend Reporting, Marketing Fulfilment, Chargeback and Rebate Processing, Account Payable etc. It also helps in master data management. Most pharma firms get their data from third party providers, but the data quality isn’t the best available. RPA can enrich the collected data and cut down from the process of third party aggregation.
- Rebate processing/chargeback processing: This is a commercial process where the pharma firm pays back rebate to the wholesaler and requires many integrations. In most companies, there’s still an element of manual processes involved, which can be significantly reduced with RPA. For instance, when a wholesaler submits a rebate, there is a defined timeline. RPA removes the manual process from the system and saves integration costs. Different enterprises are in various stages of RPA integration currently – some are focusing on fully automated systems, and some on semi-automated ones. RPA is very valuable from an organisational perspective as it can save integration costs to a large extent, sometimes even by millions.
- Regulatory submissions: During regulatory submission process, a lot of time and effort gets invested in quality check. RPA can apply Optical Character Recognition (OCR) and related technologies to automate this process.
What to look out for in your RPA solution?
When you look for an RPA solution or a service provider, you must check whether the solution can ensure security, scalability, and ability to integrate flexibly with third party technologies. Besides, it must also be easy to use from a user’s perspective. A quality RPA system should be functional from both, the technical and the end user’s stand point. As an organisation, a decision maker may feel that one is more important and adapt your system accordingly. However, both sides should come into play and it should always be considered in the selection process.
Additionally, it is vital to have clarity and discuss right at the beginning what your desired outcome is, and what your business requirements are. The way you partner with your service provider can have a definitive impact on the project. In the end, your verdict on which RPA product is right for you also depends on various factors which are unique to your business.
Earlier, it was predicted that the robotic technology will grow to a $1.3 trillion industry. It is now estimated that the current growth rate would surpass the predictions. Though RPA hasn’t completely replaced mainstream processes yet, it is gradually enabling pharma firms to focus on bringing safe and effective drugs to market at a lower cost by helping to address some of the key administrative tasks. It’s only a matter of time before the FDA is convinced that robots can do exactly what humans are doing today.