How Digital CTA Signatures Cut Site Activation Time by 40%
Site activation is the single most variable part of study start-up. Across our 2025 portfolio, the gap between the fastest and slowest 10% of sites — on the same protocol — was 6.4 weeks. The largest single driver of that variance? How long it took to get a signed Clinical Trial Agreement back on paper.
The Study: 120 Sites, 18 Countries, Controlled Comparison
A mid-tier pharma sponsor ran two parallel Phase 3 oncology studies with identical protocols, identical CTA terms, and overlapping country footprints. The first used the sponsor's legacy paper-and-courier CTA process; the second used RWEOne's fully digital CTA signature workflow with e-signature, identity verification, and automated counterparty routing.
What the Numbers Tell Us
It Is Not Just Signatures — It Is Onboarding Too
The sites that were onboarded digitally completed GCP refresher training, delegation-of-authority logs, EDC user provisioning, and eCRF training modules in the same integrated onboarding workflow. Legacy sites had these tasks handed off across four different inboxes, with an average of 3.2 days of idle time between each handoff.
- CTA, ICF, delegation logs, and GCP training all routed in a single sequenced workflow
- Automated reminders with copy to CRA escalation after 48 hours
- Full audit trail of every view, signature, and delay reason
- Regulatory-grade e-signature accepted in all ICH and 18 additional markets
The Business Case Compounds
A 40% reduction in site activation across 120 sites translates to roughly 5 fewer weeks of study start-up for the median sponsor. For a typical Phase 3 oncology compound, every earlier day of first patient dosing is worth hundreds of thousands of dollars in commercial time and, more importantly, earlier patient access.