Accelerating Innovation for Emerging Biopharma
We help emerging and mid-sized biopharma and CROs overcome the pressures of limited resources, complex operations, and evolving regulatory demands. Alethium amplifes the impact of every dollar spent, accelerates study startup, and reduces risk for complex decentralized and hybrid trials.
Why Clients Choose Us
Direct Impact
Our clients don’t just use Alethium — they shape it. As an emerging digital-first platform, we integrate client feedback directly into development. Suggestions aren’t deferred to a roadmap; they’re implemented and deployed, keeping every client’s priorities central to how our system evolves.
Know, Like and Trust
Clients want to work with people they know, like, and trust. This principle guides every conversation, decision, and delivery at Alethium. Through strong relationships, we deliver faster, safer, and more reliable studies that are as rewarding to execute as they are successful.
Alacrity
As an agile, results-driven company, Alethium focuses entirely on trial success. Decisions are fast, execution is direct, and our clients never encounter red tape or organizational bloat.
Transparency
Transparency is a core principle at Alethium. From pricing to project execution, we operate with complete clarity. This approach builds trust, reduces risk, and creates lasting partnerships grounded in shared success.
Who We Serve
We serve biopharmas and CROs operating at the intersection of innovation and complexity. Alethium’s digital-first architecture supports decentralized and hybrid trials that require real-time automation, standardized data models, and the ability to execute demanding multi-arm protocols across global study environments.
Value-Driven Biopharma
We amplify the impact of every dollar spent. Alethium is built for emerging biopharmas and CROs working with tight budgets. By combining automation and Behavior-Driven Development, Lean sponsors gain the speed, adaptability, and confidence to run complex trials with the performance and oversight of far larger organizations without the cost or bureaucracy.
What Success Looks Like
A successful study is delivered with precision: timelines met, budgets controlled, and risks proactively mitigated. Alethium’s digital first CDMS ensures operational efficiency and protocol compliance across every workflow, producing verified data that drives confident decisions. For us, success extends beyond technology. It is the consistent reliability, transparency, and partnership that turn first engagements into enduring client relationships.
Where We Excel
Complex and Fast-Paced
Our system is designed for complex multi-arm clinical trials with demanding protocol requirements requiring rapid turnaround times. Protocol-driven automations manage risk, speed onboarding and provide secure actionable data at scale.
Decentralized and Hybrid Trials
Every element of Alethium has been meticulously engineered for decentralized and hybrid clinical trials. Our automation framework, event-driven architecture, and audit log at the core effectively manage complexity, alleviate burdens on participants and sites, and mitigate risks.
Global Reach
Alethium unifies regional requirements into a single compliant automation platform, supporting 400+ languages and regional hosting. Behavior-Driven Development (BDD) preserves protocol fidelity across regions, while encryption and HIPAA, GDPR, and LGPD compliance keep all participant data secure and compliant.
Phase II and Phase III Studies
We partner with emerging biopharmas and CROs running Phase II and Phase III studies, providing the automation, oversight, and scalability required for complex, time-sensitive trials.
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
Alethium supports small to mid-sized biopharma companies and CROs needing an digital-first integrated CDMS with a flexible team for decentralized and hybrid trials.
Alethium provides eConsent, televisits, and remote monitoring tools that reduce site burden and ensure regulatory compliance.
Yes. Alethium’s solutions are designed for small to mid-sized organizations but scale seamlessly to support global studies.
Clients choose Alethium for its digital-first Clinical Data Management System (CDMS), Automation Engine, proven compliance assurance, value-based pricing, and responsive, easy-to-work-with team.
Alethium aligns with FDA 21 CFR Part 11, ICH E6 GCP, HIPAA, GDPR, and LGPD to deliver audit-ready clinical trial operations.
