How to Automate RealTime-CTMS

A visit window is a date the site does not get to move

RealTime-CTMS is the clinical trial management system used by research sites, site networks, academic medical centres and Phase I units, and it sits at the centre of the RealTime eClinical Solutions platform. The people in it every day are coordinators, regulatory staff, recruiters and the site's finance team.

A research site is a small business with an unusual constraint. It does not own the work it does. The protocol belongs to the sponsor, the approval belongs to the IRB, and the visit windows belong to the protocol. A participant seen a day outside their window is a deviation that has to be documented and explained, however good the reason.

So the site's calendar is not really its own, and neither is its paperwork. Everything a site does is done to somebody else's specification, recorded in a way somebody else will inspect, and paid for on somebody else's schedule.

The coordinator's week belongs to other people's systems

Count the logins on a coordinator's desk and the shape of the job becomes obvious.

Each sponsor brings its own EDC, and the queries in it will not answer themselves. Drug supply sits in an interactive response system that belongs to the study rather than the site. Central lab results arrive in a lab portal per protocol. Payments are tracked in a sponsor or CRO portal, and an invoice raised in March gets paid in July unless somebody keeps asking.

Then the dates that belong to no single study. Continuing review with the IRB, and an approval that expires whether or not anyone remembered it. Good clinical practice and human subjects training for everyone on the delegation log, held on the training provider's own site with a date on each transcript. Licences, CVs, protocol amendments to acknowledge. A monitor will ask for all of it, and finding out during the visit is the expensive way to find out.

RealTime-CTMS

Training current before a monitor asks Transcripts read against the delegation log each week, so an expiring GCP certificate is a calendar entry rather than a finding in a monitoring report.

Approvals that do not lapse Continuing review and approval dates checked on the IRB's own portal, with anything inside sixty days raised while a submission can still be prepared.

Sponsor invoices actually paid Payment portals read on a schedule, so what cleared gets reconciled and what has sat since March gets chased with a date attached to it.

RealTime holds the study the site is responsible for

The platform is deep in the parts of research a site actually owns.

RealTime-CTMS calculates study target dates and visit windows automatically and runs task management with alerts and notifications on top of them, alongside prescreening logs, visit tracking logs and enrolment metrics. Study finances cover contracts and budgets, screen fail ratios and maximums, milestone payment tracking, receivables and payables, with custom reporting through inSites. eSource captures study data electronically and eReg holds the regulatory documents, so the investigator site file is not a physical binder somebody has to stand next to. Engage! and MyStudyManager handle recruitment and the participant's own view, and GlobalPay and SitePay move money to sites and to participants.

That is most of the site's own world, and it works because the data is either created at the site or arrives through a channel RealTime built.

The sponsor's EDC is not that channel. Neither is the IRB's submission site, the training provider's transcript page, the central lab portal or the CRO's payment system. Each has its own login, its own layout, and no interest in the site's schedule.

A monitoring visit stops being a fortnight of preparation

Those five sites take five logins between them and hold every date the study is judged on. Read weekly, none of those dates has to be remembered by anyone.

Training transcripts read against the delegation log each week, so a certificate expiring next month is a calendar entry rather than a finding. IRB approvals and continuing review dates checked on the IRB's own portal, with anything inside sixty days raised while a submission can still be prepared.

Sponsor and CRO payment portals read on a schedule, so an invoice that cleared gets reconciled and one that has sat since March gets chased with a date attached. Open queries counted per study each morning, so the protocol carrying forty of them is visible before a monitor mentions it. Referral portals and study listings checked, so a volunteer who put their hand up on Friday is called on Monday.

One boundary here is not ours to set, and it is the point of the whole exercise. Trial data integrity is regulated, and source data is never something an agent alters. What runs unattended is reading, listing and flagging. Every eSource entry, every EDC record and every document in the regulatory file stays the work of delegated study staff, and anything that reaches a participant is drafted and waits for a qualified person to send.

The binder still belongs to the study team

None of that involves touching a study record, which is exactly why it can run overnight. It is fetching, and fetching is what a site currently pays qualified people to do.

WebRun is an AI agent that works a real Chrome browser, signed in the way your staff are. It opens the sponsor's portal, the IRB site, the training provider or the lab, reads what is there, and returns a list with the dates attached.

Runs happen on your schedule in your own private environment, sessions are not shared between tools, and a workflow can be restricted to a named list of domains. You can watch a run and stop it.

Every workflow below is already built, and each names the site it signs into.