AB2BC Trials

A guided workspace for clinical-trial programmes — from Pre-IND to Phase IV — where every file, decision and change sits on a tamper-evident audit trail. In preview: not yet for regulated use.

Request early access

Who it is for

Small teams carrying a programme through regulators, without an enterprise system behind them.

Sponsors and biotech start-ups

One place for each programme: its phases, its documents and who changed what, ready to show a partner, an auditor or an inspector.

Quality and regulatory teams

See the full history of every record — who uploaded it, who viewed or downloaded it, and when — without chasing email threads.

Consultants and CROs

Work inside the sponsor’s workspace with the role they give you, and hand the programme back with its history intact.

What the preview already does

Phase by phase

Each trial is laid out by phase — Pre-IND, Phase I, II and III, NDA / BLA and Phase IV — with its own documents and status.

Files with a chain of custody

Upload documents per trial and phase, or drop large files through a secure SFTP box (SSH only). Every upload and download is logged.

A tamper-evident audit trail

Each event is linked to the one before it with a cryptographic hash, so a changed or deleted entry shows up when the log is checked.

Roles and approvals

New accounts are reviewed before they get access, and each person sees only what their role allows. Role changes are logged too.

Sealed snapshots

Freeze a programme into a version-tagged archive with a fingerprint file, restore an earlier one, or move it to cold storage.

Sign in with your AB2BC wallet

No new password to manage: sign in with the AB2BC wallet. The workspace speaks English, Traditional Chinese and Spanish.

Where it stands — plainly

Preview, not validated. AB2BC Trials is work in progress. It has not been through computer-system validation, so it must not be used for regulated activity yet.
Designed toward the rules, not certified by them. It is being built with 21 CFR Part 11, EU GMP Annex 11 and ICH E6(R3) in mind. No software is “compliant” on its own: compliance is shown by the sponsor’s validation of the system in its own use.
No patient data in the preview. Use made-up or public documents only.
Coming next: validation documentation, institutional sign-in for organisations, and an assistant to help draft and check documents — each announced here when it is ready.

How to get early access

1 · Tell us about your programme

Phase, team size and what you need first. We reply with what the preview can and cannot do for you.

Request access

2 · Get an AB2BC wallet

Your wallet is how you sign in. It takes a minute, in the browser.

Get the wallet

3 · Sign in once approved

We approve your account and set your role; then you sign in to the workspace with your wallet.

Open AB2BC Trials

Questions

Is AB2BC Trials 21 CFR Part 11 compliant?

Not as a claim we can make today. It is built with Part 11 in mind — audit trail, access control, record integrity — but it is a preview that has not been validated. Compliance comes from validating a system for its intended use.

Can I put patient data in it?

No, not in the preview. Use made-up or public documents only.

What does it cost?

Pricing is not set yet. Nothing is charged without telling you first and in writing.

How does it relate to AB2BC Healthcare and Pharmacy?

They are separate: Healthcare and Pharmacy serve practices and patients; Trials serves the teams that develop medicines. Drug developers can also start from AB2BC Pharmacy for suppliers and developers.

Connected care, with your own doctor

Practices: ask about our pilot · Doctors: join as a verified provider · Patients: join with your practice code

AB2BC Healthcare provides software and care-team services to licensed medical practices. Your practice remains your healthcare provider and its record stays your official record. Not an emergency service — in an emergency, call 911.