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image of Cybersecurity, Research Data Management (RDM), and Regulatory Compliance in Clinical Trials

Abstract

Introduction

The intersection of drug discovery and cybersecurity is becoming critical as the pharmaceutical sector adopts digital technologies to drive research and development. Drug discovery entails extensive collaboration and large volumes of data, making it highly susceptible to cyberattacks. Emerging technologies, such as big data analytics, artificial intelligence (AI), and cloud computing, hold significant innovation potential but also pose risks to the industry that can undermine intellectual property (IP), clinical trial results, and collaborative research. This review discusses the importance of cybersecurity in the drug discovery process. The focus is on determining major threats, defining best practices for protecting sensitive information, and ensuring compliance with regulatory requirements. The objective is to highlight the strategic significance of cybersecurity practices in protecting research integrity and fostering innovation.

Methods

The review-based approach is employed to analyze present-day trends in drug discovery cybersecurity. Emerging technologies, security issues, regulatory needs, and the security controls most frequently utilized in the industry, such as encryption, multi-factor authentication, and secure data sharing, are discussed in the chapter.

Results

The pharmaceutical sector has advanced significantly in securing sensitive research information through robust cybersecurity measures. However, the vulnerabilities remain for cloud security as well as for protecting AI models. Adhering to the regulatory guidelines of GDPR (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act) remains a concern as international norms evolve.

Discussion

As digital technologies transform drug discovery, cybersecurity has become crucial in protecting sensitive data and intellectual property rights. Strengthening compliance with evolving regulations is key to ensuring safety and innovative pharmaceutical research.

Conclusion

Cybersecurity is critical in preserving the integrity of drug discovery. With the increasing adoption of digital technologies, pharmaceutical firms must implement robust cybersecurity measures to protect sensitive information, ensure compliance, and foster innovation in a secure environment.

© 2025 Bentham Science Publishers
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2025-09-12
2025-10-31

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/content/journals/rrct/10.2174/0115748871360236250901072442
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Cybersecurity, Research Data Management (RDM), and Regulatory Compliance in Clinical Trials
Bentham Science Publishers ; https://doi.org/10.2174/0115748871360236250901072442
/content/journals/rrct/10.2174/0115748871360236250901072442
/content/journals/rrct/10.2174/0115748871360236250901072442
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  • Article Type:     Review Article
Keywords: regulatory compliance ; Cybersecurity ; general data protection regulation ; intellectual property ; health insurance portability and accountability act ; drug discovery

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