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

Virendra S Gomase1,2

  • 1S.P. Mandali's Prin. L. N. Welingkar Institute of Management Development & Research, Mumbai, 400019, India.

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|September 15, 2025
PubMed
Summary
This summary is machine-generated.

Cybersecurity is vital for drug discovery as digital technologies increase risks to sensitive data and intellectual property. Implementing robust security measures and regulatory compliance is essential for protecting research integrity and fostering innovation.

Keywords:
CybersecurityGDPR.HIPAAdrug discoveryintellectual propertyregulatory compliance

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Area of Science:

  • * Pharmaceutical R&D
  • * Digital transformation in drug discovery
  • * Cybersecurity in life sciences

Background:

  • * Drug discovery increasingly relies on digital technologies, creating vulnerabilities.
  • * Large datasets and collaborative research are susceptible to cyberattacks.
  • * Emerging tech like AI and cloud computing introduce new security risks to intellectual property and clinical trial data.

Purpose of the Study:

  • * To review the critical role of cybersecurity in the drug discovery process.
  • * To identify major cyber threats and outline best practices for data protection.
  • * To emphasize the strategic importance of cybersecurity for research integrity and innovation.

Main Methods:

  • * A review-based approach was used to analyze current trends in drug discovery cybersecurity.
  • * Discussion includes emerging technologies, security challenges, and regulatory requirements.
  • * Examination of common security controls like encryption and multi-factor authentication.

Main Results:

  • * The pharmaceutical industry has improved data security, but cloud and AI model vulnerabilities persist.
  • * Compliance with General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA) remains a challenge.
  • * Evolving international cybersecurity norms require continuous adaptation.

Conclusions:

  • * Cybersecurity is indispensable for safeguarding sensitive data and intellectual property in digital drug discovery.
  • * Strengthening regulatory compliance is key to ensuring safety and promoting pharmaceutical innovation.
  • * Robust cybersecurity measures are necessary for protecting information and fostering innovation in a secure research environment.