Run Compliant Studies for FDA and Health Canada

Alethios simplifies regulatory research with built-in compliance tools and rapid study execution to support your submissions

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The Solutions to Common

Regulatory Studies

Challenges

Practical Strategies to Overcome Common Industry Challenges

Common Challenges

1

Complex compliance makes meeting standards like Part 11 and HIPAA time-consuming

2

Slow recruitment delays studies by limiting qualified participants

3

High costs arise from inefficiencies and strict regulatory requirements

4

Diverse endpoints make data validation and compliance challenging

The Alethios Solution

Compliance Built-In

Tools for Part 11 and HIPAA compliance, designed for FDA and Health Canada submissions

Secure Platform

Centralized, scalable platform to manage sensitive data securely

Comprehensive Endpoint Collection

Collect data from participant-reported feedback, wearables, and at-home tests with full compliance

Faster Study Launch

Configure studies using AI Quickstart or pre-built regulatory protocols

Flexible Options to Fit Your Research Needs

Self-Service

Conduct your research independently using Alethios’ platform to design and manage your study. Perfect for marketing studies or teams that already manage research protocols

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Hybrid

Get assistance with participant support, intervention distribution, or study logistics while retaining full control over your study

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Turn-Key

Collaborate with a principal investigator from our network to handle your study end-to-end, from design to execution

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Conduct

Regulatory Studies

In 5 Steps

1

Design Your Study

Upload your protocol or use AI Quickstart to define your study parameters.

2

Recruit Participants

Access a curated panel matching your ideal consumer profile.

3

Distribute Materials

Provide products and instructions for home or on-site use.

4

Monitor Feedback

Collect multimedia responses and analyze sentiment in real time.

5

Review Insights

Access comprehensive reports to drive decisions.

Transforming Industry Research, One Study at a Time

Challenge

Hofseth BioCare needed to conduct a decentralized clinical trial on the efficacy of CARDIO Salmon Oil capsules, but traditional research methods made recruitment, data collection, and compliance slow and costly

Solution

Using Alethios, Hofseth BioCare leveraged AI-driven participant recruitment, wearable device integration, and automated data collection to streamline study execution and ensure real-time monitoring

Result

The study reached full enrollment quickly, with 94% adherence and high-quality data from 127 wearable devices, enabling faster insights and efficiency

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