Buyer Checklist for Security Assessment of eClinical Vendors

Clinical trials are the backbone of medical research, driving innovation and ensuring the safety and efficacy of new treatments. With the rise of eClinical systems, the management of clinical trials has become more efficient and data-driven. However, this shift also brings significant security challenges. Ensuring the protection of sensitive clinical data is paramount. This checklist provides a comprehensive guide for clients to assess the security measures of potential eClinical vendors, ensuring they meet stringent security standards and effectively safeguard critical information.

Security Governance

1. Chief Information Security Officer (CISO)
   • Verify the appointment of a dedicated CISO responsible for overseeing the entire information security program and ensuring its effectiveness. A CISO demonstrates the vendor’s commitment to prioritizing security.
2. Information Security Assurance Program
   • Confirm the existence of a well-defined Information Security Management System (ISMS) that is certified to ISO 27001:2013 standards. This certification indicates robust implementation and monitoring of security measures.
3. Security Policy Alignment
   • Ensure the vendor’s security policies align with ISO/IEC 27002:2005 or above and are ISO 27001:2013 certified. Alignment with these standards ensures best practices in information security management.
4. Security Accreditations
   • Request recent audit reports to validate ISO 27001 or SOC2 compliance. Regular external audits demonstrate ongoing adherence to high security standards.
5. Legal and Regulatory Compliance
   • Check for compliance with requirements such as PCIDSS, GDPR, HIPAA, etc., and confirm that relevant employees are certified. This ensures the vendor meets necessary legal and regulatory obligations.
6. Cloud Security Controls
   • Verify that the vendor’s security controls for cloud services align with ISO 27017:2015 standards. This alignment ensures cloud services are managed with robust security measures.

Information Risk Assessment

1. Regular Risk Assessments
   • Ensure the vendor performs regular risk assessments using standardized materials to identify and mitigate potential security risks. Regular assessments help maintain a strong security posture.
2. Risk Assessment Methodology
   • Verify that the methodology includes business impact assessments, threat profiling, and vulnerability assessments. Comprehensive methodologies ensure all potential risks are evaluated and managed.
3. Information Risk Register
   • Confirm that risk ratings are documented in an information risk register, with treatment actions approved by stakeholders. This practice ensures systematic tracking and management of risks.
4. Threat and Vulnerability Management
   • Assess the vendor’s approach to managing threats and conducting vulnerability assessments. Effective management helps prevent security incidents and maintain system integrity.

Security Management

1. Documented Security Policy
   • Review the vendor’s comprehensive security policy and supporting Acceptable Use Policies (AUPs). Well-documented policies provide clear guidelines for maintaining security.
2. Legal and Regulatory Compliance Reviews
   • Ensure that regular reviews are conducted to stay compliant with relevant laws and regulations. Ongoing reviews help adapt to changing legal and regulatory landscapes.

People Management

1. Information Security Responsibilities
   • Verify that security responsibilities are considered during employment screening and regularly reinforced through training and awareness programs. This ensures employees understand and uphold security practices.
2. Asset Return upon Termination
   • Confirm that processes are in place for the return of documentation, equipment, and software upon employee termination. This prevents unauthorized access to sensitive information.

Physical Asset Management

1. Secure Storage and Disposal
   • Ensure sensitive information is securely managed in the cloud and not stored locally, reducing the risk of data breaches. Secure disposal practices protect against unauthorized access to decommissioned equipment.
2. Mobile Device Security
   • Check for Mobile Device Management (MDM) and Mobile Content Management (MCM) systems to protect mobile devices. These systems ensure that mobile devices are secure and data is protected.

System Development

1. Secure Development Methodology
   • Confirm that the system development methodology is consistently applied and source code is protected against unauthorized access. Secure methodologies prevent vulnerabilities in software development.
2. Security Testing
   • Verify that security tests, including vulnerability assessments and penetration testing, are performed before deployment. Thorough testing ensures systems are resilient against attacks.

Business Application Management

1. Application Security
   • Ensure business applications are protected against unauthorized access and manipulation. Secure applications safeguard sensitive data and maintain operational integrity.

System Access

1. Access Control Mechanisms
   • Confirm that access is controlled using mechanisms such as passwords, tokens, and biometrics. These controls enforce authorized access and protect against unauthorized entry.
2. AAA Implementation
   • Verify the implementation of Authentication, Authorization, and Accounting (AAA) to manage user access. AAA ensures users are properly authenticated and their actions are tracked.

System Management

1. Server and Network Security
   • Check for standard configurations and protections against malicious attacks for servers and network storage systems. Proper configuration and security measures safeguard against breaches.
2. Change Management
   • Ensure changes are tested and documented before going live, following a documented change management process. This practice prevents unintended disruptions and maintains system stability.

Business Continuity

1. Business Continuity Plans
   • Confirm that business continuity plans are developed to maintain critical processes during disruptions. Effective plans ensure operational resilience in emergencies.

Security Monitoring and Improvement

1. Security Audits
   • Review independent security audit reports and recommendations for continuous improvement. Regular audits help identify and address security gaps.
2. Threat and Incident Management
   • Verify that processes are in place for identifying, remediating vulnerabilities, and managing security incidents. Effective incident management minimizes the impact of security breaches.

Use this checklist to perform a thorough security assessment of potential eClinical vendors, ensuring they meet stringent security requirements and effectively protect sensitive clinical data.

Cloudbyz builds products and services with security, privacy, compliance, and transparency in mind. The same is being effectively implemented using several international standards, regulations and guidelines. All of our solutions are compliant to FDA 21 CFR Part 11, GAMP5, HIPAA guidelines. To learn more about our best-in-class compliance policies and quality practices, please visit the Compliance page on our website www.cloudbyz.com.