Compliant digital healthcare and clinical trials start with Evrotrust
Regulated industries like healthcare and life sciences can now move care and research online with confidence. Power secure patient and staff identity verification with reusable eIDs, capture legally valid consent with qualified eSignatures and control data access with role-based permissions, supported by eIDAS, GDPR and cross-border compliance – all in a single solution.
Streamline clinical workflows end to end. Evrotrust delivers remote patient verification, eConsent and QES with authenticated, audit trailed, timestamped records, meeting EU/US requirements including ICH-GCP, 21 CFR Part 11, Annex 11 and GDPR for cross-border operations.
Verify patient identities online
Onboard patients in clinical trials fully remotely or authenticate their identities. Trusted solution for decentralized trials (virtual clinical trials). Suitable for integration in ePRO platforms. Enjoy improved data reliability and GDPR compliance. Patient data stays with the patient and the site.
Get eConsent with QES
Enable patients to sign informed consent forms and any other documents with eIDAS qualified eSignatures – with the full legal validity of handwritten ones. Eliminate the risk of informed consent violations. No additional devices or special knowledge are needed from the patient. Suitable for integration in ePRO platforms and patient consent tools.
Outsourced liability
Evrotrust is more than a software vendor. As a Qualified Trust Service Provider (QTSP), it plays a role similar to a notary in the paper-based world and enters info a direct contract with signers. Our QTSP status is audited and recertified annually by EU conformity assessment bodies.
Cross-border coverage
Meet US and EU-wide compliance standards with a single solution: Evrotrust works with over 60 nationalities, making it perfect for multinational trials.
Maintain transparent audit trails
All your clinical data entries, forms, protocols, etc. are timestamped and preserved for full 21 CFR Part 11, Annex 11, ICH-GCP, and EMA/FDA audit readiness. Suitable for integration into EDC platforms.
Secure role-based access
Ensure data security and compliance across your platform with role-based access restricted only to authorized personnel, verified via Evrotrust electronic authentication.
Trial records retention
Evrotrust offers qualified preservation services for long-term storage of digitally signed files. Documents are kept in a way that allows their signatures and highest level of legal validity to be automatically verified for 10+ years.
Sign digital contracts
Cut administrative overhead and speed up business with vendors, sites, and partners through advanced or qualified electronic signing. Suitable for integration in CTMS platforms.
Account management
Evrotrust’s dedicated healthcare team is available to support you throughout compliance validation, smooth integration and day-to-day operations, ensuring your digital workflows run reliably at scale.
Healthcare & digital health
Transform healthcare delivery with trusted digital patient care. From patient sign-offs to telemedicine, Evrotrust helps providers deliver faster, safer, and fully compliant digital care.
Digitize all signatures
Forget about printing or scanning documents ever again. Sign medical documents, informed consent forms, prescriptions, and more with qualified electronic signatures (QES) – legally binding, eIDAS- and GDPR-compliant. Suitable for integration in all medical software. No additional devices or special knowledge is required from your patients or staff.
Facilitate telemedicine
Consult patients entirely online: with eID and qualified eSignatures, you have everything you need for telehealth services. Identify patients and sign ambulatory care reports, consents, and prescriptions with doctors and patients in full compliance. All legal, all secure. Cross-border, pan-EU compliant.
Verify identities securely
Onboard new patients online or verify the identities or professional credentials of medical staff remotely and improve access to services.
Electronic health records (EHR)
Maintain a secure record of sensitive health data. Limit access to patients and authorized personnel only and comply with all data privacy regulations.
Eliminate paperwork
Boost operational efficiency and speed up all admin processes by turning all contracts, HR/internal flows, and patient communication fully digital.
Paper archive digitalization
Digitize your existing paper archives by scanning them and applying Evrotrust’s automated qualified signing. This makes the transition smooth and compliant, helping you meet archival obligations in the digital era.
Evrotrust ROI Calculator – Healthcare & Life Sciences
ROI calculator
Calculate the value of faster, compliant healthcare workflows
Estimate cost savings, efficiency gains, and risk reduction based on your organization.
This calculator provides an indicative estimate of the potential business impact of digital identity, electronic consent, and electronic signing in healthcare and life sciences, based on the inputs provided and predefined assumptions. Actual results may vary depending on your workflows, implementation scope, regulatory requirements, study or care model, and market conditions. For a tailored ROI assessment based on your organization, please contact our team: https://evrotrust.com/contact-sales/
Cater to your organization’s needs with advanced and qualified electronic signatures.
Healthcare and life sciences operate under some of the strictest regulatory regimes in the world. Evrotrust is designed to support digital workflows that remain legally robust across borders, without forcing teams to compromise on protocol compliance, data protection or auditability.
Our solutions align with key EU and US frameworks, so providers, CROs and vendors can digitize confidently.
eIDAS-compliant identity and signatures for qualified and advanced electronic signing
GDPR-aligned data processing and access control for sensitive health and study data
21 CFR Part 11 readiness with authenticated, timestamped and tamper-evident audit trails
Support for ICH-GCP and EMA/FDA expectations around eConsent and source data integrity
Role-based access controls for EHR, EDC and ePRO platforms, restricted to verified users
Integrate Evrotrust with your existing software
API
Seamlessly integrate the Evrotrust mobile app with your product.
Are qualified electronic signatures legally valid for patient consent and clinical trial documentation?
Are Evrotrust’s solutions suitable for cross-border use?
Can Evrotrust be used for eConsent under 21 CFR Part 11 and ICH-GCP?
How does Evrotrust verify patient or medical staff identity remotely?
What is needed for the patient to sign with a qualified signature?
Can Evrotrust integrate with your EHR, EDC or ePRO systems?
What is the difference between QES and AES for healthcare workflows?
How are audit trails and timestamped records generated and stored?
Are qualified electronic signatures legally valid for patient consent and clinical trial documentation?
Yes. Qualified electronic signatures (QES) are the only digital signatures in the EU that have the same legal effect as a handwritten signature. They are accepted for patient consent, clinical trial documentation, and other high-risk healthcare workflows where maximum legal assurance is required.
Are Evrotrust’s solutions suitable for cross-border use?
Yes. Evrotrust is an EU-based, accredited Qualified Trust Service Provider (QTSP) under the eIDAS regulation, which guarantees legal recognition of qualified signatures across all EU member states. Because eIDAS sets some of the strictest requirements globally for identity verification, electronic signatures and auditability, meeting them also aligns with regulatory expectations in North America, APAC, the Middle East and other regions.
Can Evrotrust be used for eConsent under 21 CFR Part 11 and ICH-GCP?
Yes. Evrotrust offers PKI-based digital signatures: cryptographic signatures that bind signer identity to the record. Our solutions support authenticated, timestamped, and tamper-evident signing flows with full audit history. These capabilities help meet key expectations of 21 CFR Part 11, ICH-GCP and EMA/FDA guidance for electronic consent and source data integrity.
How does Evrotrust verify patient or medical staff identity remotely?
Evrotrust performs remote identity verification using government-issued ID documents, biometric checks, automated authenticity analysis, and manual supervision. The verified identity is then tied to a reusable eID that can be used for future signings, onboarding or access control.
What is needed for the patient to sign with a qualified signature?
To sign with a qualified signature, the patient needs to verify their identity, whether in the Evrotrust app or your native software integrated with our services. After completing the one-time remote identification, they can sign documents securely from their phone whenever needed.
Can Evrotrust integrate with your EHR, EDC or ePRO systems?
Yes. Evrotrust can be integrated via API or SDK to fit directly into your EHR, EDC or ePRO workflows. Many organizations also use Evrotrust through existing connectors in third-party signing and document management platforms.
What is the difference between QES and AES for healthcare workflows?
QES offers the highest level of legal assurance and is recommended for regulated or high-risk processes such as informed consent and clinical documentation. AES is suitable for lower-risk or internal workflows where strong signing is needed but QES is not required by regulation.
How are audit trails and timestamped records generated and stored?
Each action in the signing or verification flow is authenticated, timestamped, and logged. These records are stored in a tamper-evident format to support compliance with 21 CFR Part 11, ICH-GCP, GDPR, and internal audit requirements.
Looking for the best trust services to digitize your business?
Evrotrust’s reliable, well-rounded toolkit will meet all digitization needs your company faces.
