For Site Management Organizations
Trial-ready sites.
Protocol-consistent conduct.
The learning platform that gets sites trained and activation-ready, now with an AI learning agent for every trial, embedded in the CTMS your teams already work in.
Sourced, version-cited answers
Less login friction
Fewer preventable deviations
The Adoption Trap
Your coordinators
work in a maze
17
additional systems a typical oncology study layers on top of the site’s own, each a new login
Applied Clinical Trials (2025)
55%
of sites rank sponsor technology setup and training as their single greatest startup burden, above budgeting and contracting
Advarra 2023 Study Activation Survey, 500+ sites
~70%
of sites report six or more separate logins per study, before counting decentralized and wearable tech
Advarra 2023 Study Activation Survey
>60%
of site professionals report staffing shortages, and new research staff can take up to a year to fully ramp
2024 SCRS Site Landscape Survey; WCG
Every one of those systems is one more login, one more password, one more place the answer might be hiding.
Why Deviations Happen
Many deviations are preventable
when the right information arrives in time.
01
The amendment lived in an email
Protocol changes arrive by email and portal. Without version control and a clear effective date, staff misapply the change or work from a superseded version, and deviation risk spikes after every amendment.
02
Training decays before it is used
Site initiation training happens weeks before the procedure it covered. By Visit 3, retraining has not caught up to the moment the knowledge is needed.
03
Turnover resets the clock
Coordinator churn runs high industry-wide. Every departure takes trial knowledge with it; every new hire ramps mid-study, often without the full study document set at hand.
04
Interpretation drifts across sites
The same protocol gets read slightly differently at each site. Sponsor and CRO communication lag and uneven PI engagement widen the gap, and multi-site SMOs absorb it as monitoring findings, queries, and CAPAs.
People stay in the loop, so deviations will still happen. The goal is to reduce the preventable, information-driven ones: version-control failures, effective-date confusion, communication lag, and training decay.
There Is A Better Way
A proven readiness base.
A new AI agent for every trial.
The Base · Today
Site readiness and activation
The Revinova learning platform gets sites trained, activated, and demonstrably ready to operate: onboarding, GCP, processes, and your SOPs, tracked by person, site, and study.
Proven and in production.
extends into →
The New Layer · The Pilot
An AI learning agent per trial
Each trial gets its own agent for live enablement and guidance, embedded in the CTMS. It draws on the current approved study documents at the point of work and supports staff through conduct, helping reduce preventable deviations.
What we are inviting you to pilot.
Readiness gets a site ready to operate. The per-trial agent carries approved knowledge into live conduct, where the deviations actually happen.
Site Readiness Platform
The learning platform gets sites
trained, activated, and demonstrably ready.
Onboarding, GCP, processes, and your SOPs, tracked by person, site, and study. Proven and in production.
Readiness & activation training
Hosted by Revinova. Gets coordinators, investigators, and site staff ready to operate before the first visit.
GCP, SOP, and onboarding tracking
Required training assigned, completed, and recorded by person, site, and study — ready for inspection.
Completion records by person and study
Know exactly who has trained on what, and when. No spreadsheets, no chasing.
AI-built training from your documents
Upload approved study materials and AI assembles structured, role-based modules for your team to review and deploy.
AWS Bedrock connectors
Infrastructure built on SOC 2 and HIPAA-aligned AWS Bedrock. Accreditation documentation available on request.
Single sign-on & role-based access
Staff access the platform through existing credentials. No new passwords, no new portals to manage.
AI Builds Training
Turn study documents
into ready-to-deploy training
Before a site ever sees the agent, the platform compresses the slowest part of getting trial-ready: building the training itself. Upload the approved study documents, and AI assembles structured, role-based training your team reviews and deploys.
1
Upload approved study documents
Protocol, manuals, SOPs, and study-specific materials, the content you already maintain.
2
AI builds the training
It drafts structured, role-based modules from those documents, mapped to who needs to know what.
3
Review, approve, deploy
Your team reviews and approves before release, then pushes trial-ready training to the site.
Hours back, not weeks
Content that took weeks to build by hand comes together in a fraction of the time.
Built by the people who know
Your content owners stay in control; AI does the assembly, not the approval.
Deploy faster, update faster
When a document changes, regenerate the affected training instead of rebuilding from scratch.
How The Agent Stays Correct
The agent holds no static content.
It draws only from the current approved study documents, under controlled version governance, and retrieves the right one at the moment it is asked.
The controlled study document package
The operational answer rarely lives only in the IRB-approved protocol. It lives across the controlled set:
Each carrying its version and effective date · plus the Revinova LMS the site trained on
Per-trial AI agent
Retrieves the released, current version, then answers with the source and version cited
In the workflow
Embedded via SSO or workflow integration, where staff already work
Why this matters: every answer is limited to approved study materials, shows its source document and version, logs the interaction, and escalates to a person when the materials do not support an answer.
Not Another Login
Not another system
for the PI to log into.
Your teams already work in the CTMS all day. Embedding help where they are reduces adoption friction, because it goes with the workflow instead of adding one more place to check.
Embedded in the workflow
It works within the CTMS session staff are already in, so there is little new to learn. We do not give sites a new system; we meet them in the one they use.
Answers without the scramble
Less hunting across portals, binders, inboxes, and shared drives mid-visit. Ask in place, keep working.
Surfaces what changed
On login, the agent can flag pertinent updates for that user: amendments, memo changes, new procedures, anything released since their last session.
Ask anything in scope
Visit windows, lab kit handling, eligibility nuances, reporting steps. If it is in the approved study documents, the answer is a question away.
It Guides Because It Knows
Generic AI sees a question.
The trial assistant sees the site, the study, and the person asking.
Context Aware
- It lives inside the CTMS — knows where the user is working and what task is in front of them
- Knows the site and the trial, so answers reflect this protocol at this location, not a generic study
- Offers guidance at the point of action, before the misstep, not after the query
- Scoped to the workflows and conventions of the CTMS your client actually runs
User Aware
- Knows who is asking — the site and the trial, so answers reflect this protocol at this location
- Knows the role: a CRC, a sub-investigator, and a data manager get guidance fit to their responsibilities
- Knows their training record, so it can close the exact gap between what was taught and what is being done
One assistant per trial. Each one is sealed to its own protocol, its own sites, its own approved materials.
Quality Teams Can Trust It
Answers your quality
team can stand behind
General AI can produce a confident answer that is not actually supported by any source, the kind of plausible-but-unsupported response that has no place in trial conduct. The controls below are designed to prevent that.
01
Approved materials only
Every response is limited to the current approved study materials. Nothing improvised, nothing from the open internet.
02
Source and version shown
Each answer displays its supporting source document and version, so staff can verify and monitors can trace any guidance to its origin.
03
Escalates when unsupported
When the approved materials do not support an answer, the agent says so and routes the question to a person, rather than producing an unsupported one.
04
Logged and reviewable
Interactions are logged with access controls, so you can show what was asked, what was answered, and which source and version backed it.
Designed to support GCP-aligned training, controlled content, traceability, audit trails, and ALCOA+ data-integrity principles where applicable. Platform hosted on SOC 2 and HIPAA-aligned infrastructure (AWS Bedrock); accreditation documentation available on request.
A Tuesday At Site 014
Coordinator running three studies. Patient in the chair at 9:40. Here is the difference.
Without
With the trial assistant
Did Amendment 4 change this visit? Search inbox, call the CRA, check the portal.
Login briefing already flagged it: Visit 3 lab kit changed. Source shown.
Which sample handling applies here or in the other study? Risky recall.
Asks in place. Answer is scoped to this trial only, cited to the lab manual.
New hire shadows for weeks, asks the same questions everyone asked.
New hire asks the assistant, ramps in days, with answers tied to training.
Uncertain moment mid-visit becomes a judgment call. Sometimes a deviation.
Uncertain moment becomes a sourced answer. Procedure done right the first time.
Multiply by every coordinator, every visit, every site, every study you run.
What Your SMO Gets
What your SMO gets
Reduced preventable deviation risk
Just-in-time, sourced guidance helps close the gap between what was trained and what gets done, lowering the preventable, information-driven deviations before they become findings.
More consistent execution across sites
Sites work from the same current approved documents, narrowing the interpretation gaps that drive monitoring findings.
Cleaner data, fewer queries
Procedures done right the first time support better source documentation and less downstream rework.
Knowledge that survives turnover
Trial knowledge lives in the platform, not only in the coordinator who left, so retraining and ramp lean on a controlled source instead of memory.
Inspection readiness
Training compliance, communications, and agent interactions are documented and traceable, supporting CAPA and inspection preparation.
A stronger story for sponsors
Walk into feasibility with activation-ready sites and a documented, AI-supported quality layer few competitors can show.
Pilot
A pilot for sites ready
to innovate early.
You already trust the platform to get sites trained and ready. For organizations eager to move early on AI in trial conduct, this is an invitation to pilot the next layer: a per-trial agent that supports conduct and helps reduce preventable deviations, where your teams already work.
1
Pick one live trial
We inventory its approved study documents and name a content owner.
2
Stand up the agent
Embedded via SSO or workflow integration, scoped to your sites and roles.
3
Measure one cycle
Preventable deviations, query volume, and time-to-answer, before and after.
Free Assessment
Discover where your business stands on the AI Journey
Get a personalized AI readiness report in minutes. Understand your gaps and your next steps.
Get Your Free AI Report →
Takes less than 5 minutes
Ready to bring the agent
into your CTMS?
Schedule a demo and see how it works inside your workflow, with your study documents.
revinova.com