The questions sites ask before they bring in TrialConnx.

TrialConnx covers study startup. That’s the work between a study landing on your desk and the site being ready to enroll: feasibility and site selection up front, then budgets, contracts, regulatory document collection, IRB submissions, and getting the site ready to activate.

Once the site activates and patients start enrolling (the point teams often call first-patient-in), your CTMS and EDC take over for the trial itself. TrialConnx is what gets each study to that point faster, with fewer surprises on the way.

TrialConnx is built for the people who run study startup: research sites, site networks, and academic medical centers, plus the CRO and sponsor teams who coordinate startup alongside them. If your work is getting studies from intake through activation, across your own staff and any outside help, it’s built for you.

Yes. It works for a single site and scales to a network running startup across many sites. You get a portfolio view across all of them, with each site’s studies, owners, and bottlenecks in one place, so a central team can see where every site stands without chasing each one separately.

Vendors and TrialConnx do different jobs. A vendor or CRO adds capacity. They take work like regulatory submissions or budget negotiation off your team’s plate. TrialConnx gives you the view across all of that work, so you can see where every study stands, what’s holding it up, and who owns the next step, whether your own staff or an outside vendor is doing it.

If anything, sites that outsource tend to need that view more, not less. Once your own people and a few vendors are all working across several studies, no one place shows you the full picture. Your vendors hand over deliverables. They don’t tell you which studies are on track or where the portfolio is slipping. That’s the gap TrialConnx fills.

How many studies you run matters less than how much coordination each one takes. A few signs it will earn its place at your scale:

• Studies stall and it’s hard to say where or why.
• Status lives in email threads, meetings, and personal spreadsheets.
• Several people, sometimes outside vendors too, are touching startup with no shared view.
• Leadership wants a portfolio picture that takes real work to pull together.

If those sound familiar, the number of studies isn’t really what decides it. The coordination load is.

Most teams can make email and shared drives work. The real question is what it takes to keep it working. A lot of that effort never shows up anywhere: time spent pulling status together before a meeting, documents that turn up late because nobody owned the follow-up, and handoffs that stall the week someone is out.

TrialConnx isn’t there to replace your coordinators. It takes that manual tracking off their plate so their time can go to work that actually moves studies forward.

No. TrialConnx works with OnCore, it doesn’t replace it. OnCore is a full CTMS built for running an active trial. TrialConnx handles what comes earlier: the pre-activation coordination across feasibility, budgets, contracts, and IRB that has to happen before a site can enroll anyone.

Plenty of teams run both. OnCore stays the system of record once a study is live, TrialConnx runs the startup work, and the two hand off cleanly at site activation.

Generic project tools can track tasks, but they don’t know anything about clinical trial startup. You end up building the fields, formulas, and views yourself, then rebuilding them every time your process shifts.

TrialConnx is built for study startup from the ground up. It already knows what an IRB submission is, what a feasibility assessment looks like, and how the milestones connect. You get clinical workflows, study-level reporting, ownership tracking, and audit-ready coordination without standing the system up yourself. And it grows with your study portfolio rather than your spreadsheet upkeep.

TrialConnx is API-first and built to sit alongside the systems you already run. Your CTMS stays the system of record for trial conduct. TrialConnx organizes the startup work that leads up to it, then passes the relevant study data across at activation. What moves between systems is startup data and that handoff. Patient records and trial-conduct data stay where they belong, in your CTMS and EDC.

The specific integrations get worked out during onboarding, around the systems you actually use, and our team sorts out what connects and how with your IT group.

TrialConnx tracks and coordinates the IRB submission process across all of your studies, from document readiness to submission status, revision cycles, and approval timelines. It doesn’t replace your IRB portal, like IRBManager or SMART IRB. What it adds is a clear view of where every submission stands, and it flags the ones at risk of slipping so an approval delay doesn’t quietly hold up activation.

Yes, and it’s one of the main reasons sites bring TrialConnx in. You get a single view of every study in startup: where it stands, what’s blocking it, who owns the next step, and which milestones are at risk.

Nobody has to compile status out of spreadsheets, inboxes, and meetings. Your research leaders and PIs all see the same current picture, without waiting for someone to build a report first.

Getting started is mostly about shaping TrialConnx around the way your team already runs startup. We set up your startup stages and workflows, bring in the studies you have in flight, and get your people working in it. There’s no year-long rollout. The fastest way to see what it looks like for your operation is to walk through it with us.