S10 / Assess

Vendor qualification.

Auditing a CRO, lab, or vendor on behalf of a sponsor. Risk scoring, approve/reject recommendation, ongoing-monitoring framework.

5 min read

You'll leave with: What sponsor-side vendor qualification looks like when the vendor is an Indian CRO — and where ground-truth matters.

/ Who this is for

The fit.

Sponsors qualifying CROs. CROs auditing their sub-vendors. Combination-product founders qualifying CDMOs.

/ The work itself

What this delivers.

Vendor qualification report with risk scoring, approve/reject recommendation, ongoing-monitoring framework.

/ Why this matters

Where the edge is.

India ground-truth — auditing Indian vendors more credibly than a US-based firm flying in. Network depth for inside view of operational reality vs presented reality.

/ How engagement runs

The shape of the work.

Every engagement is scoped per situation. The shape — focused diagnostic, structured implementation, ongoing partnership — emerges from the discovery conversation rather than a fixed package. Some engagements are short and intense; some are months-long structural builds; some are recurring quality oversight. We talk first, then scope.

Discovery.

Confirm vendor scope and qualification criteria.

Scoping.

Proposal aligned to vendor count and audit depth.

Audit.

Document review, on-site or remote with on-site partner, risk scoring.

Report.

Qualification scorecard, recommendation, ongoing-monitoring plan.

What to do next.

If this is the work in front of you, the next step is a conversation. I read every message and respond personally. No contact forms. No sales sequence. Just a discovery conversation to understand whether the fit is real, and what the shape of the work would be.

Cadence promise: I publish weekly on regulated AI governance. If a week is missed, the journal entry explaining why goes up in real-time.

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