EMA Compliance
EMA Guideline on Computerized Systems and Electronic Data in Clinical Trials
Assessed and qualified by an independent computer system validation service provider (Zifo).
1. cubeCDMS
2. cubeTMF
GDPR Chapter 5
Chapter 5 of the GDPR (General Data Protection Regulation) governs the transfer of personal data to third countries or international organisations.
Under “Article 45: Transfers on the basis of an adequacy decision” of the GDPR and the European Commission’s Adequacy Decisions, personal data can flow freely from the EU to countries with adequate levels of protection, such as Japan and South Korea.
CRScube’s cloud data centers are located in Tokyo, Japan and Seoul, South Korea, allowing free data transfer from the EU without any additional safeguards.
1. Background
What are adequacy decisions?
The European Commission has the power to determine, on the basis of article 45 of Regulation (EU) 2016/679 whether a country outside the EU offers an adequate level of data protection.
The adoption of an adequacy decision involves:
a proposal from the European Commission;
an opinion of the European Data Protection Board;
an approval from representatives of EU countries;
the adoption of the decision by the European Commission.
At any time, the European Parliament and the Council may request the European Commission to maintain, amend or withdraw the adequacy decision on the grounds that its act exceeds the implementing powers provided for in the regulation.
The effect of such a decision is that personal data can flow from the EU (and Norway, Liechtenstein and Iceland) to that third country without any further safeguard being necessary. In others words, transfers to the country in question will be assimilated to intra-EU transmissions of data.
(Source: European Commission)
2. Adequacy Decisions
3. CRScube Data Centers
Solution | Main Center | DR Center |
|---|---|---|
cubeCDMS | AWS Tokyo | AWS Seoul |
cubeIWRS | ||
cubeDDC | ||
cubeBUILDER | ||
cubePRO | ||
cubeCTMS | ||
cubeSAFETY | AWS Seoul | AWS Tokyo |
cubeTMF | ||
cubeLMS |