Question 1

How does Mahalo generate eCOA forms from a clinical protocol?

Accepted Answer

Mahalo's AI parses protocol PDFs or structured SoAs to identify assessments, timepoints, and logic. It automatically builds digital eCOA forms with validation rules, multilingual support, and edit checks.

Question 2

What's the difference between Mahalo and legacy platforms like Medidata or Medable?

Accepted Answer

Mahalo is purpose-built for AI and DCT workflows. It delivers faster implementation, better modularity, and protocol-driven form generation, eliminating bottlenecks in traditional builds.

Question 3

How fast can I launch an ePRO study with Mahalo?

Accepted Answer

Studies can launch in as little as 10 days with our prebuilt templates, AI automation, and white-glove onboarding.

Question 4

Does Mahalo support therapeutic-area specific outcome assessments?

Accepted Answer

Yes. We support condition-specific instruments (e.g., oncology QoL, cognitive diaries, mental health scales) and even rare disease adaptations.

Question 5

Can Mahalo's ePRO/eCOA connect to our EDC or CRF tools?

Accepted Answer

Mahalo integrates directly with its own AI-powered EDC and CRF Builder modules and offers APIs for third-party systems.

Question 6

What regulatory standards does Mahalo comply with?

Accepted Answer

Mahalo is fully compliant with FDA eCOA guidance, 21 CFR Part 11, GDPR, HIPAA, and includes audit trails, version tracking, and secure authentication.

Question 7

What devices and languages are supported?

Accepted Answer

Mahalo works across all modern browsers and mobile devices and supports multilingual assessments (40+ languages) for global studies.

Question 8

What support does Mahalo offer during eCOA implementation?

Accepted Answer

Dedicated onboarding, expert consultation, prebuilt templates, compliance documentation, and 24/7 trial support.

ePRO & eCOA: Frequently Asked Questions

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