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Embleema

Embleema is a real-world evidence platform for Phase IV and non-interventional clinical research, long-term patient registries, and biospecimen governance. The platform unifies multimodal patient data (ePRO, wearable, site, EHR, and genomic) with sample inventory and consent status into a single operational view, enabling pharma and biotech sponsors, rare disease foundations, clinical sites, biobanks, and biospecimen managers to run compliant, scalable studies and maintain cohorts and samples fo

Their llms.txt

The beginning of the file, from our validated copy saved 2026-10-21T17:20:00.748Z. Cached copy · Source on embleema.com

# Embleema

> Embleema is a real-world evidence platform for Phase IV and non-interventional clinical research, long-term patient registries, and biospecimen governance. The platform unifies multimodal patient data (ePRO, wearable, site, EHR, and genomic) with sample inventory and consent status into a single operational view, enabling pharma and biotech sponsors, rare disease foundations, clinical sites, biobanks, and biospecimen managers to run compliant, scalable studies and maintain cohorts and samples for years of reuse. Embleema delivers complete, regulatory-grade evidence at approximately 40% lower cost than traditional CRO-led approaches.

Embleema serves five primary audiences: pharma and biotech sponsors designing Phase IV and non-interventional studies, rare disease foundations running long-term patient registries, clinical sites managing enrollment and data capture, biobanks and biospecimen managers overseeing sample reuse and consent governance, and patients participating in long-term research. The platform is configured with no-code, drag-and-drop modules, captures audit-ready data from day one, connects to over 60,000 care centers and 550+ wearables, and is aligned with ICH E6 expectations for traceability and oversight.

Key differentiators: rapid protocol configuration (days, not months), no-code study build without custom engineering, real-time multimodal data unification, long-term patient engagement tooling, dynamic consent that operates independently of any EDC, biospecimen governance that links samples to consent status, and regulatory compliance including source-tracked field-level auditability.

## Products

- [Embleema Platform](https://www.embleema.com/solutions): The core platform for non-interventional research and long-term registries. Combines site and patient apps, ePRO, EHR integration, genomic data capture, wearables, and consent management into a single configurable system.
- [Dynamic Consent](https://www.embleema.com/dynamic-consent): A standalone consent governance layer for study teams, registries, and biobanks. Enables digital capture of versioned consent, real-time re-consent for protocol amendments, secure participant re-contact after study close-out, and audited management of withdrawals and reuse. Works with any EDC or without one.
- [Unified Specimen Intelligence Solution](https://www.embleema.com/info/biospecimenintelligence): A biospecimen management product that unifies sample inventory, clinical context, and secondary-use consent in one operational view. Lets teams instantly see what samples are reusable, restricted, or require re-consent. Built for biobanks and biospecimen managers. Partnered with Astoriom for integrated specimen management.

## Solutions by audience

- [For Sponsors](https://www.embleema.com/sponsors): Disease-specific registries, post-market studies, and adaptive protocol management at a fraction of traditional CRO costs.
- [For Sites](https://www.embleema.com/sites): One-click si
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