Regulatory Considerations

FDA Guidance on Digital Health Technologies in Clinical Trials

Posted on digi By digi

As sponsors increasingly adopt digital health technologies (DHTs) like wearables, biosensors, and mobile apps in clinical trials, the U.S. Food and Drug Administration (FDA) has released specific guidance to help industry align with regulatory expectations. These tools offer promising avenues for patient-centric, remote, and real-world data collection, but must comply with rigorous standards to ensure safety, reliability, and clinical relevance.

Click to read the full article.

Regulatory Considerations, Wearables and Digital Endpoints

Informed Consent Language for Wearable Use

Posted on digi By digi

Wearables have become a vital tool in modern clinical research, enabling real-time data capture, continuous monitoring, and improved patient engagement. However, their integration into clinical trials necessitates clear and compliant informed consent language to ensure participants understand what is being collected, how it will be used, and their rights concerning the data.

Click to read the full article.

Regulatory Considerations, Wearables and Digital Endpoints

Wearable Data Auditing and Source Validation

Posted on digi By digi

With the rise of wearable devices in clinical trials, regulatory authorities have increased focus on how these digital health technologies (DHTs) generate, store, and transfer source data. For pharma sponsors and CROs, ensuring auditability and source data validation is essential for GCP compliance, regulatory acceptance, and maintaining data integrity.

Click to read the full article.

Regulatory Considerations, Wearables and Digital Endpoints

Risk Assessment for Digital Endpoint Integration

Posted on digi By digi

As clinical trials incorporate digital health technologies (DHTs) such as wearables, mobile apps, and sensors, the endpoints derived from these technologies must undergo robust risk assessment. Regulatory agencies require sponsors to proactively identify and mitigate risks related to data integrity, safety, and endpoint reliability.

Click to read the full article.

Regulatory Considerations, Wearables and Digital Endpoints