Case Study: Nucleus Network streamlines clinical trial management and achieves FDA 21 CFR Part 11 compliance with Adobe Acrobat Sign

Nucleus Network streamlines clinical trial management with Adobe Acrobat Sign

Nucleus Network, a multinational clinical research organization operating in Australia and the U.S., faced a surge in remote and fast-moving trials during the COVID‑19 pandemic that exposed the inefficiencies of paper-based processes. Managing highly regulated documentation across jurisdictions—while meeting FDA 21 CFR Part 11 requirements for signature manifestations and unique signer identification—made paperwork a persistent bottleneck for study teams.

Nucleus Network validated and implemented Adobe Acrobat Sign for regulated use, adding signature-reason fields and phone-based signer authentication to meet compliance needs. Digitizing documents enabled minute‑level turnaround instead of weeks, supported bulk signing, eliminated printing/postage costs, and now processes about 2,500 transactions monthly—improving speed, compliance, and cost-efficiency while paving the way for further integrations.

Nucleus Network

Vijay Shetty

Head of Information Technology