Your team
Expert roles and Part 11 sign-off
Seven expert workspaces draft the documents your decision needs; your team reviews them and signs with a Part 11 electronic signature that pins the evidence it was based on.
The assessment is the start; the deliverables are the point. Seven expert workspaces take the pillars and draft the documents a real decision runs on, each claim carrying its citation.
Nothing is approved by the platform. A draft becomes a decision only when a named person on your team signs it.
The seven roles#
Each role is a workspace with its own view of the study, its own task inbox, and its own deliverables. They mirror the functions that actually sit around a go/no-go table.
- Protocol Design
- Drafts the trial protocol synopsis from the verdict, design and cohort analyses — every claim cited.
- Commercial Strategy
- Market size, standard of care, value-based price, patent runway, and risk-adjusted valuation scenarios.
- CMO / VP R&D
- Portfolio-level valuation, decision-gate memos, and readout-risk framing for the go/no-go call.
- Biostatistician
- Statistical analysis plans, sample-size estimates, and data-monitoring-board materials.
- Clinical Pharmacologist
- Dose-selection memos, exposure–response modelling, and drug-interaction risk.
- Study Start-up
- Country activation tracking and contract groundwork for the sites the assessment ranked.
- CRO Commercial
- Bid-pipeline and portfolio views for CRO business-development teams.
How work reaches a role#
Roles do not sit idle waiting to be asked. Platform events raise tasks into the relevant inbox — a feasibility run completing, a protocol amendment, an interim lock, new literature landing.
- Every counter on a role workspace is computed live from that study’s task list. None of it is hand-entered.
- Each deliverable keeps an append-only revision ledger: the rationale for each edit, the citations that justify it, and a redline against the previous revision.
- Tasks trace back to the study and the pillar that raised them, so a draft is never orphaned from its evidence.
The electronic signature#
Sign-off is a 21 CFR Part 11 §11.70 electronic signature, and it captures more than a click.
- A reason for signing is mandatory — the signature records why, not just that.
- The signature pins the exact citation versions the reviewer had in front of them.
- A content hash of the signed document is recorded, so the artefact cannot be edited underneath the signature.
- A signing event is written to the audit chain, tying the signature to the run that produced the document.
The signer is derived from the authenticated session. There is no field for signing as somebody else.
Re-signature when evidence changes#
If a cited source behind a signed deliverable is later superseded, the task re-opens as requiring a fresh signature. The prior signature is not deleted — it remains in the record, attached to the evidence as it stood when it was given.
This is what makes a signed decision durable rather than merely dated: you can always tell whether it still rests on current evidence.
Related
Next
The evidence
Citations & the audit trail
What a citation contains, how the hash-chained Part 11 record makes a run tamper-evident, and how to re-open a verdict long after the meeting that used it.
OpenYour team
Workspaces & teams
One workspace per organisation, isolated from every other. How to invite colleagues, what each access level can do, and how to remove someone.
OpenStart here
Reading an assessment
The six pillars, the questions each one answers, and how to tell a number backed by several independent sources from one resting on a single record.
OpenSee a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.