Life Sciences & Pharmaceuticals

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Life Sciences & Pharmaceuticals

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Ensuring the security of data and IP through robust data governance remains a pressing challenge for pharmaceutical and life science enterprises. The Research & Development sector relies on proprietary technologies, while the broader ecosystem, including hospitals, manufacturers, and service providers, handles sensitive patient health data, susceptible to potential breaches. Additionally, amidst increasing pressures for fraud prevention and the ongoing digital transformation, enterprises must actively implement stringent data protection measures to safeguard sensitive information.

Dow Customer Story

Learn how Dow enforces export control and protect intellectual property for global collaborations

Pharmaceuticals and Life Sciences

Discover methods for safeguarding highly sensitive intellectual property and automating GxP compliance by implementing real-time automated policies

Active Control for ePHI Access and Handling

Explore how Active Control module mitigates ePHI access and misuse risks by deploying predefined best-practice policies for effective compliance

Challenges

Intellectual Property Safeguarding

In an arena where innovation is the key to staying ahead, it is critical to safeguard IP during data sharing. The pharmaceutical industry invests billions in research and development; thus, its intellectual assets are business-critical data. Unauthorized access to sensitive research can lead to loss of IP, giving competitors an undue advantage and potentially resulting in monumental financial losses.

Regulatory Compliance

Pharmaceutical companies must adhere to rigorous regulations, with a strong emphasis on complying with the standards set by the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Their data governance programs need to efficiently manage tons of regulated data, such as test results crucial to FDA approval process and financial relationships between manufacturers and physicians.

Preventing Fraud

Life sciences companies face mounting pressure to bolster their internal controls for fraud prevention, an area increasingly emphasized due to heightened scrutiny from U.S. and global enforcement agencies. This scrutiny permeates all aspects of operations, from research and development to approval, production, distribution, and sales. Life sciences companies need to ensure compliance and ethical conduct in an environment where government oversight is ever-present.

Big Data & Business Transformation

The life sciences industry is undergoing a significant digital transformation – adopting big data technologies for complex data analysis, utilizing cloud applications and mobile devices for greater operational flexibility. This comprehensive digital overhaul, though beneficial for business outcomes, brings a critical challenge: ensuring the security of vast amounts of sensitive data.

Data Governance and Security for Life Sciences

To safeguard intellectual property, prevent fraud, and uphold proper data governance practices, life sciences companies must adopt a unified approach to access management, data security, and auditing. With the increasing volume of data, a unified approach is essential for maintaining internal controls and ensuring compliance across the organization.

Centralized Policy Platform & Audit

A unified policy management and data governance system forms the bedrock of effective internal controls. By centrally managing business, security and compliance needs as attribute-based policies, life sciences companies can streamline their data governance, ensuring consistent application of policies across all organizations and data types.

Data-Centric Security Enforcement

Enforcing data-centric security policies in real time enables logical data segregation, which safeguard sensitive assets and ensure compliance specially amidst the vast datasets of big data environments. Policy enforcement also implements encryption controls like dynamic data masking and Digital Rights Management, which helps to maintain data confidentiality in third-party data sharing.

Automate and Prevent

Policy enforcement helps to automate access control and data protection, preventing conflicts of interest, bribery, and unauthorized approvals. Instead of detecting and mitigating violations after they occur, real-time policy enforcement can automatically prevent conflicts of interest or inappropriate access from occurring in the first place.

Centralized Monitoring

Centralized monitoring serves as a key component in the fraud prevention and risk management strategy. By monitoring and logging of all data access activities in real time, organizations are better positioned to identify suspicious and anomalous activity.

NextLabs Solution

CloudAz Centralized Policy Platform

CloudAz a zero trust policy management platform, which serves as the foundation for robust internal controls. By centrally managing business, security, and compliance requirements through attribute-based policies, life sciences companies can harmonize their data governance and fraud prevention efforts. This approach ensures the consistent application of policies across all organizational functions and data types, streamlining operations and enhancing regulatory compliance.

CloudAz Dynamic Authorization Policy Engine

CloudAz Dynamic Authorization Policy Engine continuously evaluates authorization requests from various sources. This capability is crucial for preventing unauthorized access to sensitive research and proprietary information, thereby mitigating the risk of intellectual property loss.

CloudAz Dynamic Authorization Policy Engine

Data Access Enforcer (DAE) Data Masking

For data confidentiality, DAE enables access while keeping sensitive information obfuscated. By employing techniques such as Format Preserving Encryption (FPE), segregation, and masking, DAE ensures that only authorized individuals can access and view sensitive data.

SkyDRM Digital Rights Management

SkyDRM safeguards intellectual assets being shared through robust encryption, identity, and authorization policies. With features like virtual data rooms, SkyDRM ensures that all uploaded documents are automatically protected with digital rights and monitored, thereby preventing unauthorized access and modification of sensitive data.

CloudAz Report Server

CloudAz offers centralized auditing and reporting capabilities, providing visibility into all data access activities. This ensures that companies can maintain comprehensive reporting for audit and compliance purposes, particularly in the context of stringent regulations imposed by entities like the FDA and HHS.

CloudAz Report Server

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