Frequently Asked Questions (FAQs)

Does Delegra integrate with existing eTMF systems?

Yes. Delegra is designed to bridge the gap between site-level activity and Sponsor-level oversight. All delegation logs and audit trails can be exported as high-resolution, OCR-ready PDF/A files for seamless upload into any major eTMF platform.

How is my study data secured?

Security is baked into our infrastructure. Delegra utilises enterprise-grade encryption-at-rest and in-transit. Our servers are hosted in SOC 2 Type II compliant data centers, ensuring that sensitive investigator and study data remain protected under global privacy standards.

Is formal training required for site staff?

Delegra is built on a "Zero-Training" philosophy. The interface is intuitive, mimicking the flow of traditional clinical workflows. This ensures high site adoption rates and reduces the administrative burden typically associated with implementing new digital tools.

Is the platform compliant with 21 CFR Part 11?

Absolutely. Delegra provides full electronic signature attribution, non-repudiation, and unalterable time-stamped audit trails, meeting the stringent requirements for electronic records in clinical trials.

How does Delegra handle multi-center studies?

The platform provides a centralised dashboard for Sponsors and CROs to maintain oversight across all participating sites, while ensuring that site-specific data remains siloed and secure.

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