Designed Prevention. Rapid mitigation. Active Monitoring.
Process
Risk prioritization is conducted collaboratively with each client. This approach evaluates potential and active risks according to their impact on participant safety, data integrity, regulatory compliance, and study timelines. Through this systematic process, risks are ranked and addressed proactively, ensuring that mitigation strategies are both targeted and effective.
Alethium integrates digital architecture and operational governance to control risk at its source. The platform’s proactive CDMS framework prevents errors before they occur, and our risk-based SOPs guide rapid, verified resolution when intervention is needed. Each update passes automated BDD test validation, maintaining continuous alignment with protocol and reinforcing system integrity.
Oversight is embedded in Alethium’s risk-based framework. The system continuously evaluates operational data for emerging risks, while the Alethium team monitors performance, investigates anomalies, and verifies corrective actions to sustain quality and compliance.
Architecture
Our architecture is designed from the ground up for proactive risk prevention. Integrated validation, encryption, automation, and continuous monitoring maintain data integrity, protect participants, and reduce operational exposure.
PII Security
Alethium’s fully automated enrollment streamlines every step, from recruitment and eligibility to account creation and eConsent. It enables 24/7 enrollment, accelerates first visits, and virtually eliminates protocol deviations.
Validation
Software reliability is confirmed through a multi-layer validation approach:
- Computer Software Assurance (CSA) focuses testing effort on high-risk functionality
- BDD automated tests validate every protocol requirement continuously.
- Targeted manual testing supplements automation where judgment is required.
Together, these layers ensure safety, reliability, and compliance.
Integration at the core
Alethium’s unified architecture synchronizes all services and data flows within a single operational framework.
Every action triggers automated responses that maintain system alignment, reduce manual handoffs, shorten response times, and strengthen oversight across the study lifecycle.
This unification supports rapid risk detection, proactive mitigation, and a complete traceable record of every decision and corrective action.
Event-driven Audit log
The audit log does more than record events—it drives them.
Each operational action is validated, sequenced, and tied to the correct participant and study context.
Early risk signals surface instantly, supported by verified evidence that enables immediate investigation, trend analysis, and corrective response.
Behavior-driven development (BDD)
BDD replaces static requirements with living, testable, plain-language rules shared across clinical, operational, and technical teams.
Each requirement becomes an automated test and an executable definition of system behavior.
Within Alethium’s RBQM framework, this transparency reduces ambiguity, strengthens consistency, and ensures every executed outcome matches the protocol exactly.
Comprehensive Risk Managment
RBQM is woven into every layer of Alethium’s platform and services.
Through automation, living requirements, continuous monitoring, and strong operational governance, we maintain safety, compliance, and integrity across the entire study lifecycle—empowering Sponsors and CROs to run complex trials with clarity and control.
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
A proactive framework that identifies CtQs, prioritizes risks, and applies controls across design, conduct, and reporting to protect safety, data integrity, and timelines.
It reduces operational burden, accelerates timelines, and keeps trials aligned with ICH E6 expectations, giving teams confidence to proceed.
Every oversight action is logged, encrypted, and enforced by role-based controls, aligning with FDA 21 CFR Part 11, ICH E6 GCP, HIPAA, GDPR, and LGPD.
Through automation, BDD rules, and an event-driven audit log, Alethium prevents deviations before they occur and ensures evidence is ready for rapid oversight.
RBM targets oversight where risk is highest. In Alethium, RBM is part of RBQM, so signals feed design changes, controls, and training.
