The GDPR – General Data Protection Regulation entered into force in May 2018. This regulation supplants the previous Data Protection Directive 95/46/EC, a formal set of guidelines concerning data privacy. The premise of the new regulation was to bring into line data privacy laws throughout Europe, while safeguarding the rights of EU citizens.
GDPR also establishes both general rules applying to any kind of personal data processing and specific rules applying to the processing of special categories of personal data such as health data. This had an effect on scientific research including clinical and translational research areas.
seQure, a business unit of Arithmos, examines the changes that this regulation imposed on scientific projects:
About Arithmos
We are Business and Technology experts in the Life Science industry.
We help companies to gain the best business value through technology-enabled solutions. With our business units seQure and The CQA Company, we provide Quality Compliance and Consulting services.
We deliver solutions and services for:
- Pharmacovigilance and Safety
- Regulatory Document Management
- Reporting & Analytics
- eClinical
- Cloud Services
- IT Services
- Quality Management
- Computer System Validation
- Regulatory Affairs
Our industry-leading experts combine the knowledge of processes and technologies to implement your digital strategy, enable rapidly scale-up along with fulfilling oversight, governance, and compliance requirements.
We support your:
- Digital Transformation
- Business Process Re-engineering
- System Integration
- Data-Driven Management