regenold GmbH
regenold GmbH: “regenold GmbH is an end-to-end integrated development partner for pharmaceuticals, medical devices, and drug-device combination products. Since 1994, regenold has guided more than 2,000 innovators through over 10,000 successful product submissions across 90+ countries.”
Do I need a DPO for my clinical trial?
“If your organisation processes health data as a core activity (which most pharma and medtech sponsors do) a DPO is required under GDPR. Even where the formal threshold is debatable, most EU data protection authorities and ethics committees expect a named DPO.”
在公司資料中查看What happens when my EDC or safety database provider has servers outside the EU?
“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.”
在公司資料中查看How do I handle informed consent under both the CTR and GDPR?
“The Clinical Trials Regulation and the GDPR treat consent differently. Under the CTR, informed consent covers trial participation.”
在公司資料中查看Do you support ISO 27001 certification, and are you certified yourselves?
“Yes to both. We are ourselves ISO 27001 certified, so we've built and maintain the same systems we help clients implement.”
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