Risk management has become a priority for businesses all over the world, particularly the pharmaceutical industry. The risks that pharma businesses confront, particularly in clinical trial design and execution, medication approval, product quality, and worldwide commercial practices, are rising in frequency and size in a politically and economically unstable climate.
Many pharmaceutical firms concede that they are ill-prepared to traverse these stormy seas because their risk analysis and management systems are not as strong, data-driven, action-oriented, or comprehensive as they would want.
The role of compliance risk management in the pharma industry
Advanced analytics and machine learning are quickly gaining momentum in a variety of sectors to improve risk management. For example, corporations in the energy and materials sectors have long employed advanced analytics and simulation modeling to plan huge projects like opening a new mine. A technique like this is ideal for risk assessments in the healthcare industry.
An innovative analytic method was used by one major pharmaceutical business to assist it in picking clinical trial locations for quality audits. The algorithm evaluates level characteristics to determine which places are at higher risk and which risks are more likely to occur at each location.
The company’s analytics are closely integrated with its core risk-management procedures, including risk remediation and monitoring activities carried out by its clinical operations and quality teams. The new technique detects errors that would have gone unnoticed under the company’s previous manual procedure while also freeing up 30% of its qualified personnel.
Human resources, international corruption and bribery, patient support programs, interactions with patients and health care professionals (HCPs), and reporting to regulatory authorities are all areas where pharma businesses must be compliant.
Compliance operations have typically depended on manual procedures due to the necessity for specific skills in each of these areas and the reliance on data from other sections of the company. This indicates that the effectiveness of a compliance program is limited by the number of employees allocated to it.
Moving away from monotonous duties, keeping up with expanding volumes of data, and transforming compliance into a value-creating company that predicts what may go wrong and stops it from occurring are all achievable with digital technology.
The need for Big Data and advanced analytics for compliance risk management
Since you’ll be expected to account for big data’s movement in your business, it has a direct impact on your compliance process. Every stage of data management, including collection, processing, and storage, will be scrutinized by regulatory organizations. The major goal of the thorough examination is to verify that your data is protected from threats.
You should design security measures to secure your data in order to achieve compliance status. You must demonstrate how each risk mitigation strategy works and its efficiency level during the analysis. This thorough analysis of your data security systems will make certification easy for your company.
You will need to utilize advanced analytic techniques, unlike organizations that deal with small data. In addition, competent people must be hired to evaluate data, detect security concerns, and offer mitigation solutions. As a result, if you’re dealing with huge data throughout the compliance process, you’ll need more resources than if you’re dealing with tiny data.
You will, however, benefit from the advantages of working with big data, which will allow you to provide clear forecast reports on the possibility of an attack. Auditors are more likely to establish more strict measures when utilizing this type of data during auditing than if they utilized small data. As a result, implementing big data analytics is one of the most secure methods to build some of your company’s most dependable security systems.
Big data analytics opens up big opportunities for the pharmaceutical industry. Let’s talk about how big data analytics can be utilized in pharmaceutical companies.
The application of big data and advanced analytics in compliance risk management operations
Big data and advanced analytics assists in compliance risk management operations in the following ways:
Prevention of unlawful activities
Suspicious activities should be monitored by all businesses. During these times when individuals are spending more time online, hackers’ inventiveness has skyrocketed. As a result, it is critical to always intervene and prevent the emergence of any cyber threats that might reveal consumer behavior or result in data breaches.
Knowing how to use it effectively might be difficult when you collect data on everything. Some of the big data you collect and keep may be utilized to prevent something bad from happening.
The utilization of big data enhances predictive analysis, which is an excellent method for detecting illicit activities like money laundering. When compliance officers utilize big data for internal audits, they may spot cyber hazards and take steps to prevent them. This speeds up the compliance procedure and gives your clients more trust.
Managing third parties risk
If you want to receive compliance certifications, it’s critical that you manage the risk of sharing your data with suppliers properly. You may use big data analytics to control the risks connected with vendors. This will be accomplished by assessing their capacity to secure your data prior to sharing it with them.
Assists in managing your customers
Big data plays an important part in this since it can provide insights into whatever you want to know. Big data provides you with the reports and trends you require. To achieve customer service compliance, you must satisfy your customers’ expectations and demands.
Big data gives you all you need to know. When anything goes wrong, having access to analyses and data that show you what’s wrong is quite beneficial. To guarantee that your consumers are happy, you may adjust regulations, guidelines, and more.
Use of big data analytics to leverage and improve compliance strategy
Following are some of the ways to use big data analytics to leverage and improve compliance strategy:
1. Simplification of the compliance process
Businesses frequently fail to meet certain criteria simply because they continue to rely on repetitive manual labor. Data is collected from multiple sources, authenticated, and then submitted to authorities as part of the regulatory compliance process. This can be a costly and time-consuming operation without automation. The use of big data to automate and consolidate the compliance process may save a lot of time and money while reducing mistakes.
2. Enhancing decision-making
You can make your regulatory compliance process smarter by utilizing big data. The ability to identify and forecast nuanced patterns in risk and data management is arguably the most important benefit that Big data and analytics provide enterprises. Two of the most important parts of the compliance process are these. Banks, for example may make their compliance process easier by implementing data lake designs that allow them to safely store data.
3. Keeping track of regulatory changes
Due to numerous market dynamics, regulatory requirements might alter quickly. Failure to comply with the new standards might result in a loss of reputation, financial fines, or even expensive legal action. Big data and analytics can assist you in remaining compliant by alerting you to regulatory changes so you can make the appropriate modifications.
To interpret compliance standards, Big data and analytics solutions often utilize natural language processing and deep learning. Following that, you’ll be alerted of any regulatory changes. By utilizing these tools, your company will be able to remain on top of changing regulatory needs. Similarly, aligning your compliance processes and reporting procedures to comply with regulatory changes would be easy.
Agilisium delivers a reasonable, scalable, and secure cloud and data foundation on which a business may analyze data and develop insights that solve business demands. Get in touch with us today to set up the right data foundation.
The lack of a single source of truth, quality data and ad hoc manual reporting processes undermined top management’s visibility of integrated insights on sales, sales rep interactions, marketing reach, brand performance, market share, and territory management. Understandably, the client wanted to align information that has hitherto been in silos, to gain a 360-degree product movement view, to optimize sales planning and gain competitive edge.