The clock has moved to the hospital

Authorisation is getting faster

For most of the last decade, the explanation for a slow trial start in Europe sat with the regulator. Assessment took months, multinational applications waited on the slowest Member State, and a site could reasonably point upstream.

That explanation is running out. European policy has moved from harmonising the rules to measuring how fast trials start, and the authorisation clock is being cut at both European and national level.

The target these measures serve is explicit. ACT EU, the European initiative to accelerate clinical trials, aims for two thirds of trials to recruit their first participants within 200 days of application by 2030. In the first quarter of 2026, 40.5 per cent did.Source

That 200-day measure runs from application to recruitment. It counts the regulator's time and the hospital's time together. As the regulator's share shrinks, the hospital's share is what remains.

The hospital's clock has not moved with it

Two published European studies show where the rest of the time goes.

The first is a case study of a public hospital in Alessandria, in Piedmont. The hospital mapped its activation process and improved it. Across 298 studies between November 2019 and August 2022, contract finalisation fell from 117 days to 69, and institutional approval after the ethics opinion from 29 days to 10. Studies that needed a contract went from an average of 159 days to activate to 100. (Italy, 2024)Source

That is a real improvement, and it came from the hospital's own work. Even so, at the end of the period, studies with a contract still took about 100 days to open, against 46 for studies without one. (Italy, 2024)Source The contract alone roughly doubled the time to activate.

The second is a UK study of the approvals needed for a low-risk survey of NHS staff. Run across 20 trusts, it took a median of 147.5 days from first contact with the local collaborator to the first participant. Once a trust had given its agreement, the first participant followed within a median of 6.5 days. (United Kingdom, 2024)Source The study involved no medicine, and its participants were staff. Almost all the elapsed time sat in local organisational steps.

These clocks do not run strictly one after the other. Sites often negotiate contracts while the application is being assessed. But set the hospital's 100 days against the proposed multinational timeline in the table above, and the direction is plain. On these figures, the regulator is ceasing to be the longest step.

What changes for a hospital

When authorisation was slow, a site's own start-up time was partly hidden inside it. As authorisation shortens, it becomes visible, and it becomes comparable.

A sponsor choosing sites for a multinational study can now see which hospitals open quickly and which do not, and the regulator no longer explains the difference. National funders are paying for site capacity, and they will ask what it delivered. ACT EU publishes the European figure every quarter.

A hospital that cannot state its own activation time will have it estimated for it, by sponsors and funders, from the outside.

Where a hospital's time goes

The steps are familiar to anyone who runs a research unit:

• feasibility questionnaires, often answered from scratch for each sponsor;
• contract and budget negotiation;
• institutional approval after the ethics opinion;
• dependencies such as pharmacy, radiation protection, and device approvals;
• sponsor system accounts, training, and set-up for each study;
• the site initiation visit.

Most of these steps repeat across studies. Most are run with documents and trackers that belong to each study, so what the unit learns on one trial leaves with it.

What a hospital can do

Measure its own clock. Timestamp every step from first contact to first participant, for every study. The Alessandria hospital could improve because it first knew where its days went.

Standardise what repeats. Contract templates, budget templates, and document packs agreed once with the institution shorten every negotiation that follows.

Run steps in parallel with the regulator. Feasibility, contract, and set-up can start while the application is assessed, if the unit has the capacity to see what is waiting.

Keep the record in one place, across sponsors. A unit that holds its own study record, rather than one tracker per sponsor, can see its whole portfolio and its own pace.

Report it. Evidence of activation and recruitment speed is now what sponsors, networks, and funders ask for. The hospital that can show it holds the stronger position.

How ZINOS fits

The ZINOS Clinical Site Operating System runs every study in the hospital on one record, across every sponsor. Every step from first contact to close-out is timestamped in the audit trail, so the research unit can show sponsors and funders its own pace. The improvements belong to the hospital; ZINOS gives it the evidence. See how the operating system works, or see what makes ZINOS different.

Sources

1. European Medicines Agency, "EU tracks progress towards 2030 clinical trial targets", 20 May 2026.
2. European Commission, proposal for a European Biotech Act, December 2025; Jones Day, "The proposed European Biotech Act, 100 days on", May 2026.
3. Heads of Medicines Agencies, CTCG, and MedEthics EU, FAST-EU pilot; Health Products Regulatory Authority, FAST-EU overview.
4. Paul-Ehrlich-Institut, procedures and deadlines for clinical trials (section 40(4) of the German Medicinal Products Act, as amended by the Medical Research Act).
5. ANSM, "La France s'engage avec un dispositif fast-track pour accélérer les autorisations d'essais cliniques", 20 November 2025, and the opening of applications on 16 March 2026.
6. Pelazza C. et al., "The clinical trial activation process: a case study of an Italian public hospital", Trials, 2024. PMC10998293.
7. Dunleavy et al., "Why are organisational approvals needed for low-risk staff studies in the UK? Procedures, barriers, and burdens", BMC Health Services Research 24, 1408, 15 November 2024.