Built for federally funded science
Federally funded programs carry obligations most contract research organizations are not structured for: milestone-gated phases, public reporting requirements, and agency oversight alongside institutional review. Alethium delivers the full study for government-sponsored and grant-funded programs, protocol development, IRB submission, and decentralized execution, with or without the Alethium CDP.
Our Own Federal Award
Alethium Technologies is the performing organization on a Small Business Innovation Research Phase I award from the Advanced Research Projects Agency for Health. Our team conducts the study: protocol and amendments, IRB submission and maintenance, recruitment, screening and consent, in-home clinical visits, safety monitoring, data management, analysis, and sponsor reporting.
The study is home-based and decentralized, enrolling children who are minimally verbal, with a waiver of child assent and a principal investigator who is also the company's chief executive. That combination draws scrutiny most protocols never face. ARPA-H cleared it through the agency's human subjects research oversight review, and Solutions IRB approved it under Alethium's Federalwide Assurance with the Office for Human Research Protections.
This project has been funded in whole or in part with Federal funds from the Advanced Research Projects Agency for Health (ARPA-H) under Contract No. 140D0426C0028. Phase I is financed with 100 percent Federal funds totaling $597,951. No nongovernmental funds finance this phase.
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Protocol Development for Grant-Funded Programs
Protocols authored to satisfy both the scientific aims of the award and the operational realities of execution, including single-case experimental designs and other methodologies common to federally funded research.
IRB Submission & Ethics Oversight
Full submission packages prepared and managed through central IRBs, including amendments and continuing review, with documentation maintained to the standard federal sponsors expect. Studies involving children, waivers of assent, or other Subpart D considerations are designed and justified rather than assumed.
Decentralized Execution
Remote recruitment, eConsent, televisits, and distributed data capture — the model that reaches participant populations dispersed across geography, and the model most grant-funded programs now require.
Milestone Reporting
Study conduct documented against award milestones, so progress reporting draws on the study record rather than assembled narrative.
Platform Optional
Programs already committed to institutional systems lose nothing. Alethium's services are delivered independently of the CDP where an award or an institution requires it.
Designed. Submitted. Executed.
Full-service clinical research for federally funded programs.
FAQs - Common Questions
Yes. Alethium delivers full-service clinical research for federally funded and grant-supported programs, including protocol development, IRB submission and management, decentralized study execution, and reporting aligned to award milestones.
Yes. Where an award, an institution, or an existing system commitment requires it, Alethium's services are delivered independently of the Clinical Data Platform. Protocol development, regulatory submission, and study execution do not depend on the platform being in use.
Alethium supports conventional randomized designs as well as methodologies common in federally funded research, including single-case experimental designs, usability and pilot studies, and decentralized protocols reaching geographically dispersed populations.
Study conduct is documented as it occurs, so milestone and progress reporting draws directly on the study record. Documentation is maintained to the standard federal sponsors and institutional review boards expect throughout the award period.