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Even where the formal threshold is debatable, most EU data protection authorities and ethics committees expect a named DPO.”","path":"/entities/regenold-gmbh-q140571087#company-fact-content-native-digital-agencies-ab479cf0f4f16162-a-4b02d27790070848d2d9","questionPaths":["/entities/regenold-gmbh-q140571087#company-answer-content-native-digital-agencies-ab479cf0f4f16162-a-4b02d27790070848d2d9"]},{"id":"content-native-digital-agencies-ab479cf0f4f16162-a-498842324866f417c390","label":"What happens when my EDC or safety database provider has servers outside the EU?","value":"“Using a cloud-based system with infrastructure or support teams in non-EEA countries creates a cross-border data transfer under GDPR. This requires appropriate transfer mechanisms, typically Standard Contractual Clauses plus a Transfer Impact Assessment. Where ethics committees are not satisfied with the provider's setup, we design hosted alternatives where we control the environment and keep data within the EEA.”","path":"/entities/regenold-gmbh-q140571087#company-fact-content-native-digital-agencies-ab479cf0f4f16162-a-498842324866f417c390","questionPaths":["/entities/regenold-gmbh-q140571087#company-answer-content-native-digital-agencies-ab479cf0f4f16162-a-498842324866f417c390"]},{"id":"content-native-digital-agencies-ab479cf0f4f16162-a-37a711685e2365c3a89f","label":"How do I handle informed consent under both the CTR and GDPR?","value":"“The Clinical Trials Regulation and the GDPR treat consent differently. Under the CTR, informed consent covers trial participation.”","path":"/entities/regenold-gmbh-q140571087#company-fact-content-native-digital-agencies-ab479cf0f4f16162-a-37a711685e2365c3a89f","questionPaths":["/entities/regenold-gmbh-q140571087#company-answer-content-native-digital-agencies-ab479cf0f4f16162-a-37a711685e2365c3a89f"]},{"id":"content-native-digital-agencies-ab479cf0f4f16162-a-ddcfce807ca92b72ecfd","label":"Do you support ISO 27001 certification, and are you certified yourselves?","value":"“Yes to both. 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