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GDPR Services

Data privacy solutions for your clinical trials

Why pay attention to data privacy and GDPR?

Compliance is key. Data privacy is an important topic in clinical research, especially since the implementation of the European General Data Protection Regulation (GDPR). Obtaining proper oversight of your obligations under GDPR and other data privacy legislation is critical, especially when dealing with sensitive patient data.

Complexity. It can be quite an ordeal to find your way through the complexity of GDPR compliance and other data privacy legislations in an international clinical research environment.

Understanding the requirements in the clinical study context. Being aware of the different dataflows and stakeholders involved, Salvius is capable to assist with making a proper assessment of how GDPR requirements apply to your organization in general, but also with fine-tuning GDPR requirements into fitting contract management solutions for your clinical studies.

Salvius offers:

  • DPO services
  • Data protection representative services (through alliance partner LUMIS International)
  • Customized GDPR compliance training
  • GAP analysis
  • Review of processes for compliance
  • Review of contracts and study documents for compliance, such as data processing agreements (DPAs) and patient informed consent forms (PICFs)
  • Ad hoc advice on data privacy and GDPR in relation to your clinical study

How we work:

Data Privacy tailor-made to your organization

In order to show certain external parties – especially data protection authorities – that your company is taking data privacy seriously, it is recommended to perform a GAP analysis, identify parts that are missing or to be improved, and take action where necessary.

The final result is a data privacy blueprint of your organization, and in addition processes, contracts and other study documents that are supporting compliance.

Medtech – Privacy by design

Depending on the product that is being developed, for a Medtech company it is important to involve a data privacy specialist at an early stage. This way compliance can be taken into consideration during the development of your product, which prevents an end product that is not in alignment with the current data privacy and GDPR requirements.

For more information check Biotech & Small Pharma

Please contact us for further information

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