Vakula Connect, Q2 2023: E6(R3) draft, DCT guidance and the monitoring skills gap

Our Q2 2023 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.

Vakula Connect, Q2 2023: E6(R3) draft, DCT guidance and the monitoring skills gap

Vakula Connect is our regular update for consultants deciding where to take their next assignment and for clients planning their next programme. This edition covers Q2 2023.

Market signals

  • The ICH E6(R3) draft and FDA's decentralised trial draft guidance arrived in May, and sponsors began asking for CRAs and study managers with risk-based and centralised monitoring experience.
  • GLP-1 and obesity programmes drove a surge in late-phase trial activity at several large sponsors, with knock-on demand across clinical operations and data management.
  • Medical device manufacturers started early QMSR preparation ahead of FDA's expected final rule.

Roles in demand this quarter

Titles that recurred in client requisitions: Senior CRA (risk-based monitoring), Clinical Data Manager, Medical Device Quality Engineer, Cloud DevOps Engineer. Current openings are always on our careers page.

Signal to leaders

The disciplines that were hardest to fill were the ones where clients needed judgement as well as capacity; briefing for the judgement shortened time-to-fill.

At Vakula

Our trial monitoring practice began supporting centralised monitoring pilots. We also added audit and inspection-readiness support, led by consultants with notified-body and FDA inspection experience.

For consultants

Rate, duration, location and client are disclosed before you decide to interview; you get feedback after every submission; there are no fees to candidates at any stage. Send your resume.

For clients

Send one requisition and judge the shortlist. Start here.

Join the conversation

Tell us what you are working through at info@vakulatech.com; we may feature the question in a future edition.

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