— How Alethios Works
Every study on Alethios runs on the same AI-powered software platform, Study Planner, and Study Operator. What changes is whether you choose a self-service, hybrid, turn-key, or CRO-led approach.
Self-service
You run your study end-to-end.
Hybrid
You run your study, Alethios provides support on execution, recruitment, kit distribution.
Turn-key
An independent PI from our network runs your study for you. From protocol design to clinical study report.
CRO-led
Enlist a full-stack study team with PIs, CRCs, regulatory experts and statisticians with our preferred CRO partners.
— Four Ways to Engage
Conduct your research independently using Alethios' platform to design and manage your study. Perfect for experienced research teams.
Best for: seasoned researchers and lean pilots
See how it worksGet assistance with support for participants, recruitment, study digitization, intervention distribution, or IRB submissions while running your study yourself.
Best for: teams who want operational backup, not a handoff
See how it worksCollaborate with an independent principal investigator from our network to handle your study end-to-end, from study design to statistical analysis.
Best for: brands looking for an end-to-end study run by an expert in the field
See how it worksEnlist a full-stack study team with PIs, CRCs, regulatory specialists, and statisticians through our preferred CRO partners.
Best for: teams looking for a hands-off, fully supported approach
See how it worksSelf-service mode
Build your protocol with AI Quick Start, upload one you already have, or start from scratch in Study Planner.
Configure your study design, consent flow, endpoints, and distribution plan on your own timeline.
Add surveys, wearables, and biomarker collection whenever your study needs them.
Monitor enrollment and adherence in real time with Study Operator.
Export analysis-ready data as soon as it comes in.
You're collecting consumer insights or product feedback.
You're running a simple, IRB-exempt study.
You already run studies the way a one-person research organization would.
You're an academic or startup team with a smaller study design or budget.
Best for
Seasoned researchers; academic or startup teams who want full control from day one; or teams running a simple pilot.
Hybrid mode
Get support with protocol digitization, turning an idea or existing protocol into a launch-ready study.
Hand off IRB approval preparation and submissions.
Let the Alethios team manage intervention distribution and study kit logistics.
Draw on the Alethiad Participant Community for recruitment support, or keep driving your own.
Get researcher and participant support where you need it, without giving up ownership of the study.
You want to run the study without managing logistics.
You're running your own studies but want expert advice on the approach.
You run a large number of studies a year and want a trusted partner across all of them.
You want help with the tasks you'd rather hand off, like participant support and product distribution.
Best for
Teams running their own studies, clinical or marketing-oriented, who want the process faster and smoother.
Turn-key mode
Get matched with a principal investigator from our independent research network.
Get full support on your study, from protocol development to clinical study report.
Get full researcher and participant support for the life of the study.
Keep visibility into how things are going without doing them yourself.
You want an independent researcher who understands your subject area and needs.
You want the highest level of support Alethios offers.
You want to run multiple studies at once.
You don't have an in-house team to run your own studies, like many direct-to-consumer brands.
Best for
Brands looking for end-to-end study support and an independent researcher to run your study on a best-in-class platform.
CRO-led mode
A dedicated team of PIs, CRCs, regulatory specialists, and statisticians from our preferred CRO partners.
Protocol development and study design built around your endpoints and claims.
Regulatory strategy, IRB submissions, and study documentation handled for you.
Independent data management, statistical analysis, and final study reports.
Pharmaceutical and medical device studies that need regulatory-ready data
Large or multi-arm studies that need dedicated support staff
Studies that need independent oversight of data and results
Teams that need full-time clinical operations or biostatisticians
Best for
Studies that need a fully staffed team to support their research.
— Side by Side
Self-service
Hybrid
Turn-key
CRO-led
Study design & protocol
You design it in the Study Planner.
You design it, with Alethios support where needed.
An independent principal investigator designs it for you.
Your CRO team develops the protocol around your endpoints and claims.
Recruitment
You recruit your own participants or tap into the Alethiad Participant Community.
Alethios recruits alongside you, including through the Alethiad Participant Community.
Recruitment is handled for you, from screening to enrollment.
Your CRO team manages recruitment and enrollment.
IRB & compliance
You prepare and submit your own IRB documentation.
Alethios helps prepare IRB submissions and clinicaltrials.gov listings.
Your principal investigator manages IRB submissions and compliance.
Your CRO team handles regulatory strategy, IRB submissions, and study documentation.
Day-to-day operations
You run it yourself in the Study Operator.
You run it, with Alethios support exactly where you need it.
Run by your principal investigator and team.
Run by a dedicated CRO team of PIs and CRCs.
Data analysis
You analyze exported, analysis-ready data.
You analyze exported, analysis-ready data, with support available on request.
Your principal investigator completes the analysis for you.
CRO statisticians manage the data and deliver a final study report.
Best for
Seasoned researchers or lean pilots.
Teams who want backup, not a handoff.
Brands looking for end-to-end study support and an independent researcher to run your study on a best-in-class platform.
Regulated studies that need a fully staffed team.
Tell us how your team approaches running studies, and we'll point you to the right one.