Suppr超能文献

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

作者信息

Gomase Virendra S

机构信息

S.P. Mandali's Prin. L. N. Welingkar Institute of Management Development & Research, Mumbai, 400019, India.

Amity Institute of Pharmacy (AIP), Amity University, Amity Education Valley, Pachgaon, Manesar, Gurgaon, 122413, Haryana, India.

出版信息

Rev Recent Clin Trials. 2025 Sep 12. doi: 10.2174/0115748871360236250901072442.

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.

摘要

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验