clinicalLabel.io
clinicalLabel.io
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An eLabel is a digital version of the medication label that can be accessed securely by patients and site staff using a smartphone or device. Unlike traditional paper labels, eLabels allow for real-time updates, multi-language support, and interactive content. They do not replace required printed labels but complement them to enhance usability, reduce errors, and improve the overall patient experience.
Yes. Our platform is fully validated and built to comply with all major global regulatory frameworks, including 21 CFR Part 11, EU Annex 11, and GDPR. We provide detailed documentation, validation packages, and audit trails to support sponsor and regulator expectations. Compliance and patient safety are at the core of everything we build.
We design with the patient in mind from day one. Our eLabels are accessible via QR code on any smartphone, without requiring an app download. They support multiple languages, large font options, and text-to-speech capabilities for patients with visual impairments. We support studies in North America, Europe, and beyond — with localization tailored to the needs of each trial population.
Absolutely. Our platform is built using modern APIs and open standards to allow seamless integration with RTSM, EDC, eConsent, and other eClinical systems. Whether you’re using a major vendor platform or a custom-built system, we work closely with your team to ensure smooth and secure interoperability.
Implementation timelines can vary based on study complexity, but a typical setup takes 4-6 weeks from project kickoff to go-live. We offer rapid configuration, robust testing environments, and hands-on onboarding to ensure minimal disruption and fast deployment — whether you're running a pilot or scaling to global studies.