IRB and approval cadence
Protocol, consent, IRB/EC approval, Site effectiveness, and amendment impact stay visible across studies and investigators.
Academic and nonprofit
Academic research with Sponsor-grade control and site reality.
Academic medical centers, cooperative groups, investigator-initiated trials, and nonprofits carry IRB cadence, EHR/source realities, grant constraints, coordinator turnover, sponsor responsibilities, and multi-study PI accountability at the same time.
Research operations map
IRB cadence, EHR source, PI accountability.Research operations
Academic operators live in both worlds.
Academic centers and nonprofit networks often act as Sites, Sponsors, coordinating centers, and evidence custodians at the same time.
EHR and source reality
EHR/FHIR feeds, paper-source fallback, eISF exchange, ePHI handling, source attestation, and consent boundaries stay explicit.
IRB and grant question
Which approval applies? Which PI owns the study? Which evidence is grant-, IRB-, Sponsor-, or inspector-facing?
Staffing
Coordinator turnover cannot erase operational memory.
When a coordinator turns over, the next owner inherits open source questions, training and DOA status, monitor promises, IRB deadlines, and PI decisions.
Work continuity
Document requests, training currency, delegation, overdue evidence, monitor follow-up, and source context remain visible when staffing changes.
Multi-study PI oversight
PIs can see delegated work, signature evidence, deviations, consent state, and Site obligations across studies.
Coordinator continuity question
Which work is blocked today? Which coordinator inherited it? Which evidence supports PI oversight?
Funding and evidence
Research evidence has more than one audience.
Academic and nonprofit teams may answer to Sponsors, grants, IRBs, institutional compliance, cooperative groups, monitors, and inspectors.
Grant and Sponsor evidence
Milestones, document evidence, activation state, enrollment, source questions, and follow-up remain traceable to the right audience.
Institutional controls
Access review, ePHI handling, SSO, delegation, audit trail, document lifecycle, and Site exchange stay aligned with institutional expectations.
Institutional review question
Which evidence leaves the institution? Which records contain ePHI? Which audit trail answers the external review?
First rollout
Bring the study question your team keeps rebuilding.
We will review the product path, system context, owners, evidence, and rollout approach that fit the trial work in front of you.