Data protection in clinical research is complex, highly scrutinized, and inseparable from regulatory compliance and patient trust. ObelysQ supports sponsors and clinical organizations with pragmatic, regulator-ready data protection solutions that integrate seamlessly into GxP environments. Our approach bridges legal requirements, operational realities, and clinical workflows—ensuring data protection is embedded into processes rather than treated as a standalone obligation.
ObelysQ brought clarity and structure to our data protection approach. Their deep understanding of GDPR in the context of clinical trials, combined with practical implementation support, made a real difference. We now operate with confidence in a highly regulated data environment.
Clinical Operations Director, European Biotech
Case Study
Overview: A Germany-based biotech conducting multinational clinical trials needed to strengthen its data protection framework to ensure compliance with GDPR and applicable international privacy regulations. ObelysQ was engaged to assess and enhance data protection practices specific to clinical research activities.
Challenge: The organization managed complex data flows across investigator sites, CROs, laboratories, and IT systems. Gaps existed in informed consent language, data transfer agreements, access controls, and documentation of processing activities. Increasing regulatory scrutiny created a risk of non-compliance, reputational damage, and potential trial delays.
Results: ObelysQ conducted a comprehensive data protection gap analysis, benchmarking current practices against GDPR requirements and clinical-trial-specific guidance. We developed tailored policies, updated informed consent templates, strengthened vendor oversight, and delivered targeted training to clinical teams. The biotech achieved a compliant, well-documented data protection framework fully aligned with its clinical operations.
Overview: A Swiss-based biotech required a Data Protection Officer to meet GDPR obligations but lacked the internal expertise and resources to fill the role. ObelysQ was engaged to act as the company’s external DPO, providing independent oversight and strategic guidance.
Challenge: The company processed large volumes of sensitive personal data from clinical trial participants across multiple jurisdictions, each with specific national data protection requirements. Without a qualified DPO, the organization faced risks related to data subject rights management, breach preparedness, vendor oversight, and regulatory inspections.
Results: ObelysQ integrated as the external DPO, acting as the primary point of contact for all data protection matters. We advised on Data Protection Impact Assessments (DPIAs), reviewed contracts and data processing agreements, established governance documentation, and supported interactions with partners and authorities. The proactive, embedded approach resulted in strengthened data governance.
Overview: A non-EU biotech sponsoring clinical trials in Europe was required to appoint an EU data protection representative under GDPR. ObelysQ was engaged to fulfill this role.
Challenge: The sponsor needed a reliable, knowledgeable EU-based representative capable of liaising with data protection authorities and data subjects while fully understanding the sponsor’s clinical operations and data flows. Misalignment between legal representation and operational reality posed a compliance risk.
Results: ObelysQ acted as the sponsor’s external EU data representative, ensuring accurate records of processing activities, timely handling of data subject requests, and effective communication with authorities when required.
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