Innovation Built on Experience
Alethium combines decades of software engineering and clinical operations expertise to deliver a digital-first Clinical Data Management System. This fully automated, event-driven platform is built to meet the demands of the most complex and time-sensitive trials.
Built for Trust
Since 2008, our team has worked together to refine every process and technology we deliver. Decades of experience and collaboration allow us to move quickly, manage risk with precision, and deliver technology and services optimized for speed, accuracy, and compliance.
Solutions > Imitation
Every feature at Alethium is shaped by the Jobs-to-Be-Done strategy. Instead of replicating paper-based workflows, we design solutions that solve real operational challenges by reducing friction, mitigating risk, accelerating timelines, and lowering costs across the study lifecycle.
Behavior-Driven Development
is Living Documentation
Behavior-Driven Development (BDD) is embedded across every feature, integration, and study. It transforms protocol requirements into living documentation that evolves in real time. Each change is automatically validated through Alethium’s event-driven architecture, ensuring every configuration remains transparent, rigorously tested, and fully aligned with the study protocol from setup through closeout.
Clarity from the Start
Behavior-Driven Development (BDD) provides a unified, plain-language (Gherkin) source of truth for Sponsors, CROs, and Alethium from project inception through Database Lock (DBL).
Rigorous Validation
BDD transforms RBQM from a monitoring framework into an active quality engine. Every requirement is defined, automated, and continuously verified, ensuring risks are identified early and prevented before they affect study outcomes.
Living Documentation
Gherkin remains the authoritative source of truth from inception to database lock. When requirements change, automated tests identify any misalignment immediately, and Alethium updates the CDMS and any integrations to restore full compliance before deployment.
Automated Assurance
Once all automated tests pass, Alethium’s validation pipeline confirms that the Clinical Data Management System (CDMS) and all integration are configured in exact accordance with the approved trial protocol, providing documented evidence of compliance under Computer System Assurance (CSA).
Our Architecture is Our Guarantee
Engineered with compliance and auditability at its foundation, the platform integrates CSA-verified workflows and event-driven traceability. Every process is validated for accuracy and reliability, ensuring data integrity across high-velocity, complex studies.
Event-driven architecture: The audit log is at the core of Alethium. Every action is captured in real-time, immutable, and transparent, creating a guaranteed source of truth for every trial.
Behavior-Driven Development: Features are defined and validated through living documentation, aligning all stakeholders and ensuring rigorous, high-quality delivery.
Regulatory compliance built-in: Alignment with FDA 21 CFR Part 11, ICH E6 GCP, HIPAA, GDPR, and SOC 2. Reinforced by role-based access, Individual PII record encryption, and validated controls. Alethium's CDMS architecture turns compliance into a competitive advantage.
Solving the Problems That Matter Most
Built to deliver outcomes that matter, Alethium addresses the challenges Sponsors, CROs, sites, and participants face every day. Studies move faster, operate with greater safety, and maintain full compliance.
Sponsors
Gain full control and confidence in every study with Alethium’s event-driven CDMS. Behavior-Driven Development and risk-based automation reduce uncertainty, control costs, and deliver transparent, verifiable outcomes across complex, high-velocity trials.
CROs
Coordinate seamlessly across systems through Alethium’s event-driven architecture. Automated integrations and RBQM logic unify study data, reduce validation cycles, and create a single operational source of truth for every connected platform.
Investigators
Alethium’s guided, automated workflows reduce site burden and keep every step aligned with protocol. Real-time validation and alerts prevent deviations and support clean, compliant data capture with less effort.
Participants
A multilingual, intuitive interface supports BYOD participation while maintaining strict compliance. Clear daily and study-wide guidance helps participants stay on track, and encrypted PII and PHI protection ensures data privacy at every step.
Compliance at Its Core
Built to meet the world’s most rigorous regulatory standards, our CDMS integrates compliance into every layer of design. The result is a platform that keeps studies secure, audit-ready, and trusted by Sponsors and CROs worldwide.
Schedule Your Personalized Demo
We listen to your priorities and focus on the risks that matter most to you. Every demo is tailored to your challenges.
FAQs - Common Questions
We embed risk mitigation into the platform itself: protocol-aligned workflows, automated checks, and an event-driven audit trail that surfaces issues early—so sponsors and CROs can prevent deviations, protect participants, and move faster with confidence.
Every action is captured as an immutable, time-stamped event tied to the participant record. That creates inspection-ready evidence for 21 CFR Part 11 and gives teams precise visibility to investigate, trend, and resolve issues quickly.
BDD expresses protocol rules in clear, human-readable statements and validates them with automated tests. As the study evolves, those rules stay in sync with execution—improving consistency, inspection readiness, and change control.
One platform, one partner, one audit trail. Eliminating handoffs reduces errors and cost, accelerates timelines, and ensures protocol alignment from onboarding through submission.
