Designed for regulated environments
Clinical trials demand more than strong cybersecurity. They require systems that stand up to regulatory scrutiny, protect patient data and keep the blind, the question and every analysis uncompromised. Pre.sentient processes unblinded data inside an enclave that no human can access, so it cannot be released — inadvertently or otherwise — and cannot become a source of operational bias.
The Pre.sentient platform and the quality systems around it were built to those expectations from the outset, not retrofitted to them.
~40% of Pre.sentient employees come from a cybersecurity background, which reflects how we prioritize our clients' data security.
Security
Protecting confidential clinical data.
Quality
Controlled development and documented processes.
Compliance
Supporting FDA and EU regulatory expectations.
Independently certified
Information Security Management System, independently certified to internationally recognized standards.
Quality management processes governing development, delivery and continuous improvement.
Current certificates are published in the Trust Center
Regulatory compliance and support
Record integrity and audit trails, with validation documentation available to support your Part 11 filings.
Validation documentation and supplier evidence to support your Annex 11 obligations.
Safeguards for protected health information.
Personal data processed under Article 28 terms, with a DPA available for every engagement.
Clinical trial data deserves the same rigor as the statistics applied to it.
Pre.sentient combines secure infrastructure, controlled access, encryption, continuous monitoring and independent testing to help protect sensitive clinical information throughout its lifecycle.
- Encryption at rest and in transit
- Role-based access control
- Multi-factor authentication
- Audit logging
- Continuous monitoring
- Secure backup and recovery
- Annual third-party penetration testing
- Continuous vulnerability scanning and patching
- EU data residency
Each control is described in detail in the Trust Center
Designed to support regulated workflows
Our quality systems and platform architecture are designed with the requirements of regulated clinical development in mind, including support for organizations operating under:
Our supporting controls, policies and documentation for each framework are available in the Trust Center
Trust should be verifiable
Explore certifications, documentation and security controls in the Pre.sentient Trust Center.