Services and software unified
by design.
Complex trials require a single accountable partner. Alethium delivers every service on one digital backbone: one partner, one audit trail, one point of accountability.
Clinical Trial Design
Protocols engineered for success.
Alethium identifies risk during trial design and builds protocols that are scientifically sound and operationally robust. The CDP and our services are then configured to absorb and mitigate that risk through conduct.
Regulatory & IRB
Clear guidance in a complex landscape.
Alethium's regulatory specialists deliver strategies and documentation that minimize compliance risk, streamline IRB approvals, and accelerate global submissions — giving you confidence in even the most demanding regulatory environments.
Recruitment & Retention
Modern tools for diverse enrollment.
Alethium combines targeted digital outreach, clinician-led engagement, and integrated eConsent with ID verification to recruit and enroll participants quickly and compliantly. The result: broader reach, faster enrollment, and stronger study representation.
Trial Logistics
Supply chains built into the platform.
Alethium manages depots, shipping, and customs as one digitally integrated service. Shipments release on protocol events, custody is documented from depot to door, and delivery performance is measured and audit-ready.
Data Management
Audit-ready data, managed end to end.
Alethium provides comprehensive data management services on the platform that captures the data. From database design and medical coding to submission-ready datasets, our data managers deliver compliant, efficient processes that ensure data integrity and accelerate approvals.
Lab integration
Collection to results, fully integrated.
Sample orders, courier pickups, and results flow automatically under temperature-controlled custody, tied to the participant record from collection through analysis.
Site Selection & Monitoring
Risk-based site operations, proven outcomes.
Alethium selects, activates, and monitors sites with Risk-Based Quality Management from feasibility through closeout — remote review by default, on-site visits when risk demands them.
Biostatistics & Medical Writing
Defensible results, submission-ready documents.
Alethium delivers statistical analysis plans, CDISC programming, and ICH E3 clinical study reports, produced by statisticians and writers working directly from the study record so every value carries its provenance.
Government & Grant-Funded Research
Built for federally funded science.
Alethium delivers full-service clinical research for government-sponsored and grant-supported programs — protocol development, IRB submission, and decentralized execution — with or without the Alethium CDP.
Rescue Services
Stabilize at-risk studies without starting over.
Through mid-trial or retrospective assessment, Alethium delivers a clear remediation plan to safeguard data, restore audit confidence, and accelerate recovery. Our no-cost assessment pinpoints failure points, ranks them by regulatory risk, and charts a validated path forward.
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One Partner. One Audit Trail. Full Accountability.
Every service Alethium delivers runs on the same digital backbone — so nothing falls between vendors.
FAQs
Both, by design. Alethium is a full-service CRO that runs every service on its own Clinical Data Platform. Recruitment, consent, logistics, monitoring, and data capture share one event-driven backbone, so there are no vendor handoffs to reconcile and no separate systems to integrate after the fact.
Emerging and mid-sized biopharma companies and CROs that carry the same regulatory obligations as large sponsors with far smaller teams and budgets, particularly those running decentralized, hybrid, or multi-arm protocols where coordination across vendors is the main source of risk.
Yes. Services can be engaged individually or as a full-service package. The integration advantage compounds as more services run on the platform, but each one stands on its own.
Alethium delivers clinical trial design, regulatory and IRB submissions, participant recruitment and activation, trial logistics and supply chain, site selection and monitoring, lab integration, data management, biostatistics and medical writing, government and grant-funded research support, and rescue services for studies already at risk.
Yes. Rescue Services exist for exactly that. Alethium assesses an in-flight or completed study, identifies where data integrity or compliance has broken down, ranks the findings by regulatory risk, and delivers a remediation plan. The initial assessment is offered at no cost.
A traditional CRO subcontracts recruitment, logistics, and labs to separate vendors, each with its own system, and reconciles the data afterward. Alethium delivers those services on a single platform, so a consent event can trigger a shipment and every action lands in one audit trail rather than in five disconnected records.
