Opuspec gives your teams — and their AI agents — one traceable system to run trial operations on, so you deliver sponsor work faster without adding audit risk.
In one CRO organization our founder led biostatistics for, TMF-related labor and internal audit time — people and internal audit time alone, not external inspection or system costs — ran close to a tenth of the study budget. That's the cost of reconciling documentation after the fact. Opuspec is built to remove the reconciliation step entirely.
Blinding control is enforced at the point of work assignment — the moment a task is created, not after a document already exists.
Every task is created with its blinding role, owner, and deadline built in from the start — not tagged on afterward.
Documents, approvals, and status changes generated by that task inherit its blinding status and chain of custody automatically.
Nothing needs to be reconciled before an audit. The record already exists, because the work already carried it.
Give every task an owner, a deadline, and a paper trail — automatically, not as an afterthought.
Learn more →Blinding status is inherited at task assignment, not tagged onto a document after it's created.
Learn more →Every document a task produces carries its chain of custody with it, from first draft to final approval.
Learn more →Datetime, actor, and action logged automatically, built to the QA standard major CROs already trust.
Learn more →Know what's missing before an inspector does — an assistant scans for approval and documentation gaps.
Learn more →Clear ownership and role-based access, mapped to the same blinding roles that govern your study.
Learn more →Opuspec doesn't do statistical validation, SDTM/ADaM spec management, or dataset traceability — tools like Pinnacle 21, SAS LSAF, and Veeva Vault already do that, and do it validated. Opuspec references those artifacts by ID and orchestrates the human workflow around them: who did what, when, and under what blinding constraint.
A statistical programming or QC tool. It doesn't review dataset content — it confirms the human chain of custody around it (task, document, approval) is complete.
“I spent 34 years in clinical development — pharma, biotech, CRO, and software — leading biostatistics organizations inside CROs. I personally owned TMF-related compliance cost as a line item on the budget. Opuspec is built by someone who lived this problem, not just studied it.” Founder, Opuspec — PhD Statistics, MS Operations Research & Statistics. Completing AI governance education at Harvard Medical School.
Opuspec runs on the same workflow engine behind TimeCatchApp, already used by real client teams today — extended and hardened for regulated clinical development.
Opuspec's audit trail and workflow engine are built to the QA standard used by major CROs. Formal validation (IQ/OQ/PQ) and Part 11 attestation are in progress — not yet complete. We'll say so plainly, here and everywhere else.
A first-hand look at where the labor and internal audit time really goes on a study budget — and why reconciliation, not documentation, is the expensive part.
Most systems tag a document's blinding status after it's created. Why that's structurally too late, and what enforcing it at assignment actually changes.
The case for treating documentation as a byproduct of work rather than a task reconciled after the fact — and what that means the week before an inspection.
Talk to us about a design-partner pilot — no long procurement process, no rip-and-replace.