Engineering Proof Point

Orbitrials™ — the system we built to prove the standard.

Most agencies show you screenshots of other people's marketing sites. We point at a production platform we designed, built, secured, and operate ourselves: a cloud-hosted clinical trial management and eSource system in live use at a clinical research site.

The Problem Domain

Clinical research runs on paper, email, and spreadsheets.

Research sites juggle protocol documents, visit calendars, source data, monitor access, drug accountability, participant payments, and sponsor invoicing — most of it tracked manually, all of it subject to regulatory scrutiny. The failure modes are expensive: missed visits, unbilled work, and findings at audit.

Structured eSource

Visit data is captured directly in the system against the protocol's own schedule of assessments, with query workflows for raising, responding to, and closing data questions in place.

Controlled Sponsor Access

Sponsor monitors get an isolated review portal with time-boxed, assignment-scoped access and enforced blinding — they see what they are entitled to see, and nothing adjacent to it.

Tamper-Evident Audit Trail

Record changes are written into a hash-linked audit chain with signed checkpoints and reason codes, so the history of a record can be demonstrated rather than asserted.

Operational Automation

Visit calendars generate and cascade automatically, reminders go out by email and SMS, closeout milestones trigger on schedule, and completed work converts into invoices without re-keying.

The Engineering

What we had to get right — and now bring to your build.

Access control that is enforced, not decorative

Orbitrials models a real organizational hierarchy — sponsors, sites, principal investigators, coordinators, monitors, finance — and enforces permission at the data layer, not by hiding buttons in the interface. Every screen a role should not reach returns a hard 404, not a styled error.

Regulatory-grade data handling

The platform handles protected health information, which sets the floor for everything: encryption in transit and at rest, least-privilege cloud roles, redaction of uploaded source documents, and an audit trail engineered around 21 CFR Part 11 expectations for attributable, contemporaneous, and traceable records.

Automation with an audit trail behind it

Scheduled jobs generate calendars, fire reminders, and advance closeout milestones. Every one of those automated actions is logged with the same rigor as a human action — because in a regulated system, "the software did it" is not an explanation.

Cloud infrastructure we run ourselves

Container-based deployment on AWS with private database networking, automated deployment pipelines from source control, monitored cost and performance, and live financial reporting pulled from the cloud provider and payment processor directly.

Why this matters for your project: a marketing website is a far simpler problem than a regulated clinical platform. When the team building your site or internal tool already operates a system held to that standard, the ordinary things — uptime, backups, access control, data integrity, clean handoff — stop being optional extras and become the default.

The same team. The same standard. Applied to your business.

Whether you need a website that finally loads fast and ranks, or an internal system that ends the spreadsheet chaos, it is built by the people who built Orbitrials.