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Notes from our consultants on regulatory, clinical, quality, validation, IT and staffing topics.
Vakula Connect, Q3 2026: execution is the differentiator
First edition of Vakula Connect: what moved in US life sciences and regulated IT this quarter, what it signals for leaders, the roles in demand, and news from Vakula Technologies Inc.
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ICH E6(R3): what actually changes for sponsors, CROs and CRAs
The revised GCP guideline moves from a checklist mindset to proportionate, risk-based quality. Here is what that means on a live study.
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FDA QMSR: the ISO 13485 alignment is live. What device QA teams must change
The Quality Management System Regulation replaced the old Part 820 in February 2026. The differences are fewer than feared, but they are specific.
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Computer Software Assurance vs traditional CSV: where the effort should go
FDA finalised its CSA guidance in 2025. It does not lower the bar; it moves the effort to where failure would matter.
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Risk-based monitoring that an inspector will accept
Risk-based monitoring reduces cost only when the plan is specific. Generic KRIs and vague thresholds are worse than SDV on everything.
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W2, corp-to-corp or 1099: choosing the right engagement model for a consultant
The employment model affects cost, compliance and the consultant’s take-home. Here is how we walk clients and consultants through the choice.
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Vakula Connect, Q2 2026: Briefing better, hiring faster
Our Q2 2026 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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How to brief a staffing partner so the first shortlist is right
Most bad shortlists come from thin briefs. Ten minutes of extra detail at intake saves weeks later.
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Vakula Connect, Q1 2026: QMSR in effect
Our Q1 2026 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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