Quorum

A configurable platform for oversight of clinical research portfolios: oversight boards, meetings and members, reportable events, enrollment and documents.

The problem

Oversight teams track studies, board meetings, safety events and documents across spreadsheets and email. The software that does exist is often custom-built for one organization, with its rules written into the code, so it is costly to change.

Quorum is Bithrive’s own product. Our team has spent years supporting clinical research oversight, and Quorum is new software built from what we learned there: oversight rules belong in configuration, not in code, so an organization can follow its policy today and change it tomorrow.

It is for the oversight around a portfolio of studies, not for running a study from the inside. It complements a clinical trial management system rather than replacing it.

Built today

• A configuration engine: each organization sets its own forms, workflows, reporting rules and deadlines without code changes. A second program was configured with about 130 settings and no code changes.
• Study registry, oversight boards with rosters and conflict-of-interest tracking, and meeting and report management.
• A dashboard that raises overdue reports, meetings behind cadence, boards below quorum and enrollment behind pace from the dates themselves.
• Reportable events with each organization's own recipients, clocks and follow-ups, imported by file or API and reviewed before they are saved.
• Enrollment against target by sex, race, ethnicity and age, by site and arm, with small-cell suppression.
• Data management and sharing plans kept as versioned files, with commitments tracked to their due dates.
• A controlled document workspace with a member portal. Closed-session access is an explicit grant, every file is scanned for malware, and every view and download is logged.
• An insert-only audit trail with before and after values, electronic signatures on the steps an organization marks, and a full export in open formats.
• Sign-in through SAML or OIDC, with a second factor required for local accounts.
• Scale tested with 2,000 studies, 400 boards and 100,000 documents.

Current status

Quorum is in pre-production and available for controlled pilot evaluations to validate functionality and alignment with agency requirements.

• Not yet deployed for a customer. We are looking for a first pilot.
• No authority to operate (ATO) or FedRAMP authorization yet. It is designed for a FISMA Moderate baseline, and the security assessment is still ahead.
• No third-party penetration test yet. One comes before any production use.
• Built to WCAG 2.1 AA and Section 508 with automated checks and a keyboard-only test, but a full screen-reader test is still to come, so we don't claim conformance yet.
• Provides the audit trail and electronic signatures 21 CFR Part 11 calls for, but no validation package yet.