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.
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