01
Five countries, four months, documents to dosing
Core pack received 10 April. First submissions to regulatory authorities and ethics committees in all five countries on 4 May — under four weeks. Approvals 4 to 17 July. Import licences 30 July to 28 August. Site initiation and first patient dosed, August to September.
Sponsor identity withheld under confidentiality. References available on request.
02
Enrolment at scale in a competitive indication
A phase III dermatology study: 266 patients screened, 236 randomised across eight sites.
Sponsor identity withheld under confidentiality. References available on request.
03
A device study a sponsor can verify
A knee distractor investigation: two sites, 160 screened, 156 randomised, registered as NCT03956550.
Sponsor identity withheld under confidentiality. References available on request.
