Big Data Approaches to Life Sciences

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1 Big Data Approaches to Life Sciences How big data is changing the way life sciences companies operate

2 Overview As the industry embraces innovation, it is constantly faced with the challenge of meeting rising quality standards and complying with rigorous quality requirements. This white paper defines what big data is and how life sciences companies can benefit from using it in their operations, especially in risk management and compliance. Leveraging on our experience, we present some opportunities and outline potential risks as the industry embraces the big data revolution. Compliance and operations in the life sciences industry is not what is used to be: in the past, US-based life sciences companies addressed a small number of markets, which meant that the regulatory compliance aspect of their businesses was also limited. This is no longer the case. With emerging markets now representing an increasing percentage of their revenue, the number of markets being sold into has proliferated, and regulatory standards have become a burden. Brazil, Russia and China to name a few are new markets for companies, so not they not only have to deal with FDA standards, but also regulatory bodies specific to these countries. Life sciences companies face the risk of noncompliance while they try to persist with a competitive edge, meet the challenges of expansion into emerging markets, adapt to new regulations and protect the wellness of its consumers.

3 Seizing opportunities Leveraging big data capabilities for operational excellence and effective risk management Increased regulatory complexity and requirements, reforms in health care, competition and globalization, as well as shifts population demographics are just some of the reasons that risk and compliance are underscored for life sciences organizations. Being a step ahead of today s rising compliance demands a proactive and integrated approach to effective risk management. While the concept of harnessing data is not a new one, effectively using data is a big differentiator deriving insights from information to make smarter, agile and knowledge-based decisions has become the trend among businesses, especially in the life sciences industry. It is eventual. Big data will change the way companies do business. Companies that invest and harness value from their data will be able to exhibit a distinct advantage from their competitors. What is big data? Ernst & Young defines big data as the dynamic, large and disparate volumes of data being created by people, tools and machines. It requires new, innovative and scalable technology to collect, host and analytically process the vast amounts of data gathered to derive real-time business insights that relate to consumers, risk, profit, performance, productivity management and enhanced shareholder value. While technology has enabled the bolus of big data, it is not the only consideration. Organizations need to adopt a holistic view which recognizes that excellence can only be achieved through the amalgamation of personnel, processes, technology and data. This means being able to incorporate data into their business strategy and daily operations.

4 At 360factors, we help companies to overcome industry challenges, achieve business objectives, drive sustainability so as they can deliver life enhancing health solutions for patients, families and medical professionals. Companies in the life sciences industry are dedicated to improving the health and welfare of people around the world. While the industry has made significant headway on the treatment of various medical conditions, there are still areas and patient populations whose needs are not being addressed. As life sciences companies continue to answer the needs of their consumers, they face a myriad of portfolio, regulatory and operating challenges. These companies must find the best and fastest way to high performance to achieve operating excellence, sustainability and increased margins.

5 Life Science and Big Data Helping life sciences companies leverage on big data for operational excellence, sustainability and increased margins. What big data does is eliminate the act of second-guessing. Deriving value from big data will allow organizations to make decisions with a structured approach to create and sustain competitive differentiation and market dominance. Big data presents both opportunities and challenges for companies in the life sciences industry. To harness big data, companies must be able to process and analyze it realtime, and the results need to be on hand in a way that brings about positive change or influence good business decisions. The effectiveness of the data also relies on the company s ability to integrate people, processes and technology. Life sciences companies need to start thinking and using relevant big data. Data-driven decisions can reduce inefficiency between different functions within the organization. Undoubtedly, the advent of big data has created substantial benefits to businesses and consumers, alike. However, there are also risks that go along with using big data. Risks and Considerations. Companies are met with continued regulatory pressures and requirements such as managing FDA, ACA, MHRA, SOX and FCPA. Compliance is costly and complex but the cost of noncompliance can mean safety risks, hefty fines, reputational risks and even bankruptcy. In a global and rapidly changing legal and IT landscape, it is also not always clear what legal and regulatory compliance entails. Companies are often plagues with questions: Who is responsible? Who is liable? How to best respond? What regulations apply and what does not? While traditional risks, i.e., regulatory compliance pressures, abound, new risks for consideration have come to the forefront as well. Functional managers will need to learn to embrace evidenced-based decision-making. Data can be valuable and offer business intelligence for high performance but companies will have to consider ownership and privacy issues before using big data results. In the case of medical data, ownership is sometimes not clear and using the data without the right legal foundation or securing consent from the patient can cause big problems.

6 How we can help 360factors Regulatory Risk and Compliance Management Solutions The life sciences industry is one of the most heavily regulated industries in the world. As companies are subjected to more regulations, they end up investing more on human resources and contractors across multiple departments which is a reactive action leading to increased costs, creation of silos and mistrust in risk compliance and quality data which prevents executive from making evidenced-based decisions in a timely manner. Rise to regulatory challenges. Through our industry-focused approach and using unique mapping and cognitive technologies, we help companies in the life science industry address their regulatory challenges using big data to make health care sustainable. Drive high performance. Our experts use a unique risk, compliance and quality management platform that help capture real-time, relevant data to aid in the decisionmaking process to ultimately improve business outcomes. GRC automation. Our platform further allows companies to streamline GRC as a competitive differentiator, automating the entire risk process to protect them from a host of liabilities and enforcement action as well as streamlining the risk assessment process to manage operational and regulatory compliance. In our experience, we have found that organizational information is typically historical, incomplete and inaccurate. For a forward-thinking perspective, companies must derive value from big data using unique mapping and cognitive technologies. However, traditional systems and approaches can no longer efficiently handle the speed, volume and complexity of big data.

7 Learn how Predict360 can transform your compliance management process. Call today. Schedule a FREE TRIAL and DEMO online at Headquarters 1380 Burnet Road, Suite 100 Austin, Texas Global Offices Canada Pakistan Philippines Connect with us and stay in touch Bobby O Neal Director of Sales T: E: bobby.oneal@360factors.com Sajjad Gul Director of Business Development T: E: sajjad.gul@360factors.com Rosanna Lyn Director for Product Management T: E: rosanna.lyn@360factors.com Operational Excellence. Sustainability. Increased Margins. 360factors is a cloud-based Regulatory Risk and Compliance Management Software Company specializing in Oil & Gas, Power & Utilities and Banking & Financial Services industries. 360factors platform, Predict360, uses unique mapping and cognitive technology to provide regulatory insight, predict risks and increase sustainability and margins. Predict360 helps break down silos and overlapping costs through multiple tools to improve operational excellence, visibility to risk and quality data that executives can use to make decisions in a timely manner. Additionally, it provides functional compliance managers with an out-of-the-box solution with industry-specific regulations or standards, workflows and policy & procedure templates so they can perform the day-to-day regulatory and operational risk and compliance tasks at a functional level.