A Part 11–compliant eClinical platform, built from zero and running real trials

Challenge:

Vial runs its own Phase 1 trials. Running them on vendor EDC and RTSM meant six figures per study, slow change requests, and a casebook that never quite matched how a coordinator actually works a visit. Every protocol amendment became a vendor ticket; every new form, a negotiation.

The alternative was to build — but a clinical data system is not a normal product. It has to be inspection-ready from the first day a real subject's data lands in it, and the team building it also had trials to run.

• Cost and speed: Vendor contracts scaled per trial, and a change that took us a day took a vendor weeks.
• Part 11 from day one: Audit trails, controlled e-signatures and PHI handling could not be bolted on later — the first release had to pass an inspection.
• Blinding and roles: Monitors, CRAs, data managers, investigators and blinded staff all needed different views of the same casebook, with no path for a blind to leak.
• A small team: The same people building the platform were supporting live sites. Every new concept in the product was a concept someone had to validate and document.

Solution:

We built the pieces that had to be ours — the EDC, the RTSM, and the three portals — and composed everything else from tools that already carried their own compliance story. The design rule throughout: use existing platform behaviour before inventing a new concept, so that data and forms never diverge between studies.

• Form engine with reserved-token conventions so eCRFs stay consistent across studies and protocol versions — one simpler model instead of per-study exceptions
• Audit log with append-not-mutate PHI redaction — compliant without rewriting history
• Native investigator sign-off: controlled signing reasons, re-sign rules tied to data changes and locks, delegation enforced through the Admin app
• The patient-facing surfaces that keep people enrolled: Part 11 eConsent (signature manifest, FDA 11.100(c) letter), re-consent flagging per protocol version, participant payment milestones
• RTSM v3 — cohort assignment, kit assignment, IP administration and IP log
• Source upload with de-identification and PI assessment, so a site spends minutes, not an afternoon, per visit

Impact:

Every Vial Phase 1 trial runs on the platform: sites enter data, monitors review it, investigators sign it, and the RTSM assigns kits — with no vendor in the loop. The build-vs-buy analysis that justified it held up in practice: roughly 4.7× lower cost than vendors at five trials amortised over two years.

Just as important is what it changed for the people in it. A protocol amendment is a form change we ship in a release, not a vendor ticket. A coordinator uploads source and moves on. An investigator signs with a controlled reason and the audit log tells the whole story.