Axiom Data Privacy/ GDPR Services
Axiom Data Privacy/ GDPR Services
Axiom Real-Time Metrics assists small to mid-sized life sciences companies achieve sustained compliance with the Good Clinical Practices, ISO 9001, GDPR, and applicable international industry standards and regulations.
Services Overview:
1. Agreement Generation
• Data Processing Agreement
○ Including Standard Contractual Clauses, International Data Transfer Agreements, UK Addendum
• Business Associate Agreement
2. Privacy Assessments
• Data Privacy Impact assessment
• Transfer Risk Assessment
• Compliance Assessments
3. EU/UK Representatives
• Established representative in one of the Member States where the data subjects, whose personal data are processed or whose behaviour is monitored
4. Data Protection Officer Activities
• Maintaining Sponsor compliance
• Record of Processing Activities
• Data Subject Information Form generation
• Ensure Fulfilment of Data Subject Rights
• Review:
○ Clinical Trial Agreement
○ Master Service Agreement
○ Informed Consent Form
○ Protocol
• Data Privacy Consultation
• Data Privacy Meetings
○ Regulatory requirement changes, expectations, legal standing
