$0
Estimated platform fees over 24 months
$0 setup + $0/month x 24 months
- 1 active study
- 1 site
- 1 depot
- 50 subjects
Does not fit this five-site study. Try this tier only within its limits.
Try Free within its limits →
Randomization & trial supply management
You own your trial.
You own your trial.
Make the system yours.
Configure your protocol, not a software development project. Agilix RTSM puts guided study setup, randomization, dosing and clinical supply in your team's hands—with the knowledge and quality documentation to support every step.
Sponsor-led configurationEvery feature in every tierStart on Free
For the organizations that conduct clinical trials
Sponsors & biotechsCROsUniversitiesInvestigator-led trials
The Agilix differenceYour team configures.
Your team configures.
Your trial moves forward.
Choose Agilix RTSM for a self-service approach: one configurable platform, guided setup, practical learning resources and a documented quality foundation. Keep study decisions with the people who know your protocol, with supported setup handled through reviewed configuration rather than per-study software builds.
Configuration belongs to you
Authorized sponsor, CRO, university and investigator-led teams configure products, arms, visits, dosing, cohorts and stratification themselves. Supported protocol settings do not require a separate code build for each study.
Guidance from the first step
A ten-step study design workflow takes you from investigational products to design approval and master randomization. Page-specific Help explains fields and gives worked examples while you configure.
Follow the setup steps →A knowledge base, not a guessing game
Search task-focused guides for setup, dispensing, supply, audit review and study lifecycle. Learn the prerequisites, field meanings, procedures and expected outcomes before taking action.
Explore the knowledge base →Quality documentation supports the work
The project documentation set covers requirements, design, Part 11 assessment, validation planning, code review, developer tests, integration testing, traceability and release records. Review the evidence and its scope with your quality team.
See the validation foundation →Pay only for the scale you need
Free, Basic, Silver and Gold include the same platform features. Choose capacity for your Account's studies, sites, depots and subjects; change tier as your needs change rather than buying feature unlocks.
Compare a two-year study →Control with accountability
Your organization controls its study configuration and authorized users. Approved revisions, signed actions, audit history and permission-scoped exports keep that ownership connected to evidence.
Explore the platform →Protocol flexibility, built inA serious study toolkit.
A serious study toolkit.
Available from the Free tier.
Configure the supported methods around your approved protocol. Study, site and subject capacity changes by plan; the design and operational capabilities do not.
Two randomization methods
Permuted-block randomization with treatment ratios and compatible block sizes, or Pocock-Simon minimization with configured balancing factors and imbalance controls.
Stratification & cohorts
Define stratification factors and their levels, and manage cohorts with enrollment caps and Open, Paused or Closed status. Cohort availability and eligibility are checked before allocation.
Six dosing models
Fixed, weight-based, body-surface-area (BSA), bracketed, titration and biomarker-adaptive dosing. Saved protocol rules define dose calculations and product quantities.
Dispensation to match the visit
Scheduled, product-specific visit dispensing and protocol-enabled unscheduled dispensation. Support treatment products and additional non-treatment products, with physical verification kept separate from issuance.
Two supply tracking models
Individually tracked kits for multi-arm supply, and quantity-tracked stock for single-arm and non-randomized products. Configure persistent two-arm crossover visits where the protocol requires them.
DUMMY first. Master when ready.
Generate and review a separate DUMMY randomization schedule without assigning subjects. Create the operational master from the approved design; eligible unchanged designs can reuse reviewed DUMMY settings. Export schedules for review, with generation provenance retained.
Start configuring. Then qualify your study.Ready to try today.
Ready to try today.
A clear route to clinical use.
Register an Account and begin on Free. Access to study workflows follows execution of the customer agreements; clinical activation follows approval and QA release, not registration alone.
- 01
Register & verify
Create your Account, verify your email and execute the four customer agreements.
- 02
Configure with your team
Invite users, set roles, add sites and depots, and follow the guided study design.
- 03
Preview, approve & test
Review the DUMMY schedule, obtain second-person design approval and prepare the master. Execute the revision-linked UAT package and obtain QA release.
- 04
Activate & operate
With organizational readiness confirmed, activate the approved study and manage subjects, dispensing and supply.
Documentation provided. Responsibility stays clear.
Agilix's quality documentation and technical controls support your assessment; they are not automatic regulatory certification. Your organization approves its protocol configuration, intended-use validation, training, procedures and deployment qualification before clinical use.
Understand quality responsibilities →Know the cost before you startOne study. Two years.
One study. Two years.
A transparent platform budget.
Illustrative study: 24 calendar months, 1 active study, 5 sites, 1 depot and 50 subjects. These are planning assumptions, not a claim about the average clinical trial. Capacity is shared across your Account.
$21,200
Estimated platform fees over 24 months
$2,000 setup + $800/month x 24 months
- 1 active study
- 5 sites
- 1 depot
- 50 subjects
Smallest published tier that fits this study.
Start free, choose your scale →$89,000
Estimated platform fees over 24 months
$5,000 setup + $3,500/month x 24 months
- 3 active studies
- 20 sites
- 2 depots
- 250 subjects
Fits this study, with additional Account capacity.
Start free, choose your scale →$214,000
Estimated platform fees over 24 months
$10,000 setup + $8,500/month x 24 months
- 10 active studies
- 50 sites
- 5 depots
- 1,500 subjects
Fits this study, with additional Account capacity.
Start free, choose your scale →Calculated from the current published tier settings. USD, excluding applicable taxes. Totals assume a new Account's one-time setup fee plus 24 months at the same tier, with no tier changes. Paid setup applies the first time an Account moves to a paid tier; the highest tier held in a calendar month determines that month's fee. This is a platform subscription estimate, not the full cost of conducting a trial or a binding quote. Platinum is available by contract.
Knowledge and quality, alongside configurationLearn the workflow.
Learn the workflow.
Review the evidence.
Build confidence with practical guides and a documented quality foundation. Use the knowledge base for day-to-day setup and operations; use the Trust Center to understand validation evidence and responsibilities.
Browse the knowledge base →Don't just read about Agilix RTSM.
Try configuring your study.
Start on Free, explore the guidance and see how your protocol fits. Choose a paid tier when your Account needs more capacity—not to unlock the study tools.