How European Pharmaceutical Companies Can Share Clinical Trial Data Across Borders While Maintaining European Sovereignty
European pharmaceutical companies operate in one of the most data-intensive and heavily regulated industries on the continent. A single multinational clinical trial can generate patient health records, genomic data, adverse event reports, laboratory results, and investigator documentation that must flow between trial sites across multiple EU member states, contract research organizations (CROs), regulatory authorities, and sometimes partners or affiliates outside Europe. Each of these data movements involves some of the most sensitive personal information the GDPR was designed to protect: special category health data belonging to trial participants who consented to research, not to foreign government surveillance.
The regulatory environment governing this data has become significantly more complex in the past two years. The EU Clinical Trials Regulation (536/2014) is now fully in force, with all trials required to operate through the Clinical Trials Information System (CTIS) since January 2025. The European Health Data Space (EHDS) Regulation entered into force in March 2025, creating a framework for secondary use of health data including clinical trial data that will apply from 2031. And the fundamental tension between GDPR transfer requirements and the US CLOUD Act remains unresolved for any European pharma company sharing trial data through platforms operated by US-headquartered providers.
This guide examines how European pharmaceutical companies can maintain data sovereignty over clinical trial information while meeting the cross-border sharing requirements that multinational research demands.
Executive Summary
Main Idea: European pharmaceutical companies must share clinical trial data across borders with CROs, trial sites, regulators, and research partners as a core business function. The challenge is not whether to share this data but how to share it without surrendering sovereignty over participant health records, proprietary research findings, and commercially sensitive trial outcomes. When the file sharing platforms, email systems, and managed file transfer services that carry this data are operated by providers subject to the US CLOUD Act, every cross-border data exchange creates a potential access pathway that no Standard Contractual Clause or Data Processing Agreement can technically prevent.
Why You Should Care: Clinical trial data represents a uniquely high-value intersection of regulatory obligation, patient privacy, commercial sensitivity, and intellectual property. A single molecular structure can represent years of R&D investment. Patient-level adverse event data carries both regulatory reporting obligations and profound privacy implications. Proprietary trial outcomes determine market success or failure. The EHDS will require pharmaceutical companies to share certain health data for secondary use while maintaining strict data governance. Companies that cannot demonstrate architectural sovereignty over their clinical data face both regulatory exposure under GDPR and competitive risk from IP leakage through platform-level access vulnerabilities.
5 Key Takeaways
- Clinical trial data flows are inherently cross-border and multi-party. A multinational trial involves sponsors, CROs, trial sites, ethics committees, national regulators, and the EMA. Each data exchange across organizational and geographic boundaries requires verifiable sovereignty controls, not just contractual assurances.
- The CLOUD Act creates a structural gap that contracts cannot close. When clinical trial data flows through platforms operated by US-headquartered providers, that data is subject to US government access demands regardless of where servers are located or what DPAs say. Customer-controlled encryption is the only technical measure that eliminates this exposure.
- The EHDS will expand data sharing obligations while tightening governance requirements. From 2031, clinical trial data will be subject to secondary use provisions requiring pharmaceutical companies to share data through secure processing environments with strict access controls. Companies need sovereign infrastructure now to meet these requirements when they take effect.
- CRO data exchanges are a primary sovereignty vulnerability. Pharmaceutical companies outsource significant clinical operations to CROs, creating data flows across organizational boundaries where trial protocols, patient data, and interim results move through shared platforms. The security of these exchanges determines the sovereignty of the entire trial program.
- Sovereign architecture protects both patient privacy and commercial IP simultaneously. Customer-controlled encryption, European data residency, and comprehensive audit logging address GDPR compliance, EHDS readiness, and IP protection through a single architectural decision rather than separate compliance workstreams.
The Regulatory Landscape for Clinical Trial Data
EU Clinical Trials Regulation and CTIS
The EU Clinical Trials Regulation (536/2014) replaced the previous Clinical Trials Directive with a harmonized framework that applies directly across all member states. Since January 2025, all clinical trials in the EU must operate under the CTR and submit through the Clinical Trials Information System (CTIS), the centralized portal managed by the EMA. CTIS enables sponsors to submit a single application for multinational trials and provides a coordinated assessment process, replacing the previous requirement to navigate up to 27 separate national procedures.
The CTR introduces substantial transparency requirements. Most information in the CTIS database is publicly accessible unless sponsors can justify confidentiality on grounds of commercially confidential information or personal data protection. Revised CTIS transparency rules, applicable since June 2024, require publication of nearly complete clinical trial application dossiers while allowing redaction of genuinely confidential elements. This means pharmaceutical companies must carefully manage what data enters CTIS and how supporting documentation is prepared, ensuring personal data protection while meeting transparency obligations.
The CTR’s harmonization benefits come with data management implications. A multinational trial now generates a single coordinated assessment across all participating member states, but the underlying data (patient records, safety reports, investigator documentation) still flows between trial sites, sponsors, CROs, and regulators across multiple jurisdictions. The question of which platforms carry this data and who can access those platforms at the infrastructure level is not addressed by the CTR itself.
The European Health Data Space
The EHDS Regulation, published in March 2025 and entering into force on March 26, 2025, creates the most comprehensive framework for health data sharing in the EU’s history. For pharmaceutical companies, the EHDS’s secondary use provisions are particularly significant. From March 2029, most categories of electronic health data will be subject to secondary use rules. Clinical trial data and human genetic data have an extended timeline, with secondary use provisions applying from March 2031.
Under the EHDS, pharmaceutical companies may become both data holders (required to share certain health data upon request through Health Data Access Bodies) and data users (accessing health data from other sources for research and development). The regulation covers clinical trial data, genomic data, health registry data, claims and reimbursement data, and data from medical devices. Companies that hold this data may be compelled to make it available for approved secondary use purposes including scientific research, regulatory activities, and AI development for medical devices.
The EHDS requires data to be processed in secure processing environments with strict access controls. Pharmaceutical companies that cannot demonstrate sovereign control over their clinical data infrastructure will face challenges meeting these requirements. Companies should be conducting data mapping exercises now to identify all in-scope electronic health data and its location, assessing which entities in their corporate structure will be classified as data holders, and building or upgrading technical infrastructure to meet EHDS interoperability and security standards.
GDPR Cross-Border Transfer Challenges
Clinical trial data regularly crosses borders by operational necessity. A European sponsor running a multinational trial may collect patient data at sites across Germany, France, the Netherlands, and Spain, process that data through a CRO headquartered in Ireland, submit safety reports to national regulators in each participating country and to the EMA, share interim analyses with a US-based affiliate or partner, and submit efficacy and safety data to the FDA if seeking US marketing authorization.
Within the EU/EEA, GDPR permits free movement of personal data. The complexity arises with transfers outside this area and, critically, with the platforms used for transfers within it. When a European pharmaceutical company uses a US-headquartered email provider or cloud collaboration platform to share trial data between EU sites, the data may never leave EU servers, but the provider’s corporate obligations under the CLOUD Act mean US authorities can compel access to that data regardless of geographic location. Standard Contractual Clauses and Data Processing Agreements address the contractual relationship but cannot override the provider’s legal obligations under US law.
This creates a particular challenge for the pharmaceutical industry because trial data includes GDPR special category data (health, genetic, biometric information) subject to the highest level of protection. The European Commission’s guidance on clinical trials and GDPR explicitly confirms that international transfer requirements apply to pseudonymized data where re-identification is possible, which covers the vast majority of clinical trial data held by sponsors and CROs.
Where Clinical Trial Sovereignty Is Most at Risk
Sponsor-CRO Data Exchanges
The pharmaceutical industry’s extensive use of outsourcing means that clinical data frequently moves between sponsors and CROs, often through shared platforms that neither party fully controls. CROs typically act as data processors under GDPR, operating under the sponsor’s instructions but using their own IT infrastructure. When a CRO uses a US-headquartered cloud platform to manage trial data, the sponsor’s sovereignty over that data depends entirely on the CRO’s infrastructure choices.
Modern drug development involves extensive partnerships. Emerging biopharma companies, which account for 63% of clinical trial starts, often lack in-house IT infrastructure and depend heavily on CRO platforms for data management and transfer. This creates a chain of platform dependencies where patient data may pass through multiple cloud environments, each potentially subject to foreign jurisdiction, before reaching the sponsor’s own systems.
Multi-Site Trial Coordination
A multinational clinical trial requires continuous data exchange between trial sites and the coordinating center. Investigators submit case report forms, upload laboratory results, report adverse events, and exchange protocol amendments. Site monitoring involves remote access to trial data and on-site verification visits that generate additional documentation. Each of these activities involves file sharing and communication through platforms that carry participant health data.
The CTR’s harmonized assessment process means that more trial coordination happens across borders than under the previous Directive. A Reporting Member State coordinates assessment for all participating countries, requiring data aggregation and sharing across regulatory boundaries. This operational benefit of harmonization increases the volume and frequency of cross-border clinical data flows, making the sovereignty of the communication infrastructure more important, not less.
Regulatory Submission and Safety Reporting
Pharmaceutical companies must submit safety data to multiple regulatory authorities simultaneously. Suspected Unexpected Serious Adverse Reactions (SUSARs) require expedited reporting to national competent authorities and the EMA through EudraVigilance. Annual safety reports, protocol amendments, and end-of-trial notifications all involve transfers of participant-level or aggregated health data to regulatory bodies. When these submissions are prepared and transmitted through platforms that lack sovereign architecture, the preparation environment itself becomes a vulnerability point, even if the final submission reaches regulators through secure channels.
Intellectual Property and Commercial Sensitivity
Clinical trial data is simultaneously personal health data and commercially valuable intellectual property. Proprietary molecular structures, unpublished efficacy results, manufacturing process data, and competitive intelligence about trial outcomes represent investments worth millions or billions in R&D spending. The EHDS explicitly acknowledges that health data may be protected by intellectual property rights and trade secrets, and Health Data Access Bodies can reject data access requests that pose serious risk to IP. But this protection depends on the pharmaceutical company maintaining sovereign control over the data in the first instance. Data that has already been accessed through platform-level vulnerabilities cannot be retroactively protected.
Building Sovereign Architecture for Clinical Trial Data
Customer-Controlled Encryption as the Foundation
The single most impactful architectural decision for clinical trial data sovereignty is implementing customer-controlled encryption where the pharmaceutical company generates, manages, and retains encryption keys in its own hardware security module (HSM) or key management system. Under this model, the platform provider processes encrypted data but cannot decrypt it. This means that even if the provider is subject to a CLOUD Act demand, a FISA order, or any other foreign legal compulsion, it cannot produce readable clinical trial data because it does not possess the decryption keys.
For pharmaceutical companies, this addresses multiple risk dimensions simultaneously. Patient health data is protected from unauthorized access regardless of provider jurisdiction. Proprietary research data and molecular structures cannot be accessed through platform-level vulnerabilities. Regulatory submissions and safety reports are protected during preparation. And the company can demonstrate to GDPR supervisory authorities, ethics committees, and trial participants that it maintains genuine technical control over data confidentiality.
European Deployment and Data Residency
Clinical trial data should reside on dedicated European infrastructure with technical geofencing that prevents data from leaving designated geographic boundaries. For multinational trials operating across multiple EU member states, this means ensuring that the communication and file sharing platforms used for trial coordination operate within the EU, not just that individual data centers are located in Europe.
Single-tenant deployment, where the pharmaceutical company’s platform instance runs on dedicated infrastructure rather than a shared multi-tenant environment, provides additional assurance that trial data is not commingled with data from other organizations. This is particularly relevant for companies operating in competitive therapeutic areas where the existence and parameters of ongoing trials may themselves constitute commercially sensitive information.
Comprehensive Audit Trails for Regulatory Evidence
Clinical trials are subject to inspection by national competent authorities, the EMA, and potentially the FDA for trials supporting US marketing authorization. Audit trails documenting every access, modification, and transfer of trial data are not optional. The CTR requires trial data to be archived for at least 25 years after trial completion, and sponsors must demonstrate data integrity throughout this period.
Sovereign communication platforms should generate comprehensive audit logs that record who accessed which data, when, from where, and what actions they took. These logs serve multiple functions: demonstrating GDPR compliance to supervisory authorities, satisfying Good Clinical Practice (GCP) requirements for data integrity, providing evidence for regulatory inspections, and enabling the company to detect and respond to unauthorized access attempts.
Preparing for EHDS Secondary Use Requirements
The EHDS secondary use provisions will not apply to clinical trial data until March 2031, but pharmaceutical companies should begin preparation now. The regulation requires data holders to submit descriptions of their datasets to relevant authorities and respond to requests for data access through Health Data Access Bodies. Data must be made available in secure processing environments that meet EHDS technical specifications.
Companies that already operate sovereign data governance infrastructure will be better positioned to meet these requirements. When clinical trial data is stored on platforms with customer-controlled encryption, comprehensive audit logging, and granular access controls, the company can provide structured access through EHDS mechanisms while maintaining control over what is shared, with whom, and under what conditions. Companies whose trial data is scattered across CRO platforms, US-operated cloud services, and legacy systems will face a significantly more complex compliance pathway.
The EHDS also permits individuals to opt out of secondary uses of their health data. Managing these preferences across datasets spanning multiple trials, therapeutic areas, and time periods requires centralized data management with the technical capability to identify, flag, and exclude opted-out participant data from secondary use responses. This is substantially easier to implement on sovereign platforms where the company has full architectural control.
Kiteworks Helps European Pharmaceutical Companies Share Clinical Trial Data Across Borders While Maintaining Sovereignty
The Kiteworks Private Data Network provides pharmaceutical companies with the sovereign communication infrastructure they need to share clinical trial data with CROs, trial sites, regulators, and research partners while maintaining European data sovereignty. Kiteworks operates on a customer-managed encryption model where the pharmaceutical company generates and retains encryption keys in its own key management system. Kiteworks cannot access decrypted clinical data and cannot comply with foreign government demands to produce readable trial information.
Kiteworks deploys as a single-tenant instance on dedicated European infrastructure, ensuring that clinical trial data is not commingled with data from other organizations. Policy-enforced geofencing prevents trial data from leaving designated boundaries, and comprehensive audit logging provides the evidence trail that GCP inspections, GDPR supervisory authorities, and future EHDS compliance require.
The platform unifies secure file sharing for trial documentation, protected email for investigator communications, managed file transfer for automated data exchanges between sponsor and CRO systems, and secure web forms for structured data collection under a single zero trust governance framework. This allows pharmaceutical companies to secure all clinical trial data exchange channels through one platform with consistent encryption, access controls, and audit evidence.
To learn more about maintaining sovereignty over clinical trial data while meeting cross-border sharing requirements, schedule a custom demo today.
Frequently Asked Questions
Clinical trial data combines GDPR special category health data with commercially sensitive intellectual property, making it both a high-value surveillance target and a high-value competitive intelligence target. When this data flows through platforms operated by US-headquartered providers, the CLOUD Act enables US authorities to compel the provider to produce data regardless of server location. Standard Contractual Clauses and Data Processing Agreements govern the contractual relationship but cannot override the provider’s legal obligations under US law. Customer-controlled encryption is the only measure that renders this access technically impossible because the provider cannot decrypt what it does not hold keys for.
The EHDS, which entered into force in March 2025, creates mandatory obligations for sharing electronic health data for secondary use purposes including scientific research and AI development. Clinical trial data will be subject to these provisions from March 2031. Pharmaceutical companies may be classified as data holders required to share data through Health Data Access Bodies. Companies need sovereign data governance infrastructure to manage these obligations, including the technical capability to provide structured access while protecting IP and trade secrets, and to enforce participant opt-out preferences across datasets.
Multinational clinical trials generate continuous cross-border data exchanges including case report forms between trial sites and sponsors, adverse event reports to national regulators and EudraVigilance, protocol documents shared with CROs and ethics committees, laboratory results from central labs, and interim analyses shared with data safety monitoring boards. Each exchange carries participant health data through communication platforms whose jurisdiction determines actual data sovereignty. The EU Clinical Trials Regulation’s harmonized assessment process increases cross-border coordination, making the sovereignty of file sharing and email platforms more critical than under the previous national-level system.
Pharmaceutical companies should assess CROs’ platform infrastructure as part of vendor qualification, focusing on three questions: does the CRO use communication platforms operated by providers subject to non-EU government access laws? Does the CRO implement customer-controlled encryption where the sponsor retains keys? And can the CRO provide comprehensive audit evidence of all data access for GCP inspections? Since CROs typically act as data processors using their own IT infrastructure, the sponsor’s sovereignty over trial data depends on the CRO’s platform choices. Contractual assurances are necessary but insufficient without architectural verification.
Companies should begin with a data mapping exercise to identify all in-scope electronic health data including clinical trial data, registry data, and genomic data, and assess where this data currently resides. They should evaluate which entities in their corporate structure will be classified as data holders and begin building or upgrading technical infrastructure to meet EHDS interoperability and security standards. Implementing sovereign data governance architecture now, with customer-controlled encryption, granular access controls, and comprehensive audit logging, will position companies to meet the 2031 compliance deadline for clinical trial data while addressing current GDPR and regulatory requirements simultaneously.
Additional Resources