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

5. Data Breach Management
      •  Data Breach Reporting
      •  Data Breach Notification
      •  Data Breach Register
      •  Data Breach Risk Assessment & Resolution Tracking