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Introduction

Introduction

The Dimedâ„¢ fu patient monitoring service has been used since 2006. Dimedâ„¢ fu has thus far facilitated the monitoring of more than 15,000 research subjects by reliably forwarding over 700,000 text messages. The service can be used worldwide through all major operators. Used over a secure (https) internet connection and text messages, the service provides strong data protection. In addition, it does not require installing any software.

The service is compliant with FDA CFR Title 21, part 111) and GCP guidelines2), which means that it can be used in clinical pharmaceutical trials. The service includes electronic signatures, audit trails, versioning and report generation. The service is well suited for research use and can also be utilized by healthcare professionals in monitoring patients' therapeutic control at home. The service enables cost-efficient monitoring of adverse effects or certain values measured at home, such as blood pressure, blood sugar, weight, PEF and VAS. The frequency of monitoring can be customized according to the study protocol or by the specific requirements of the therapeutic area. The service also allows setting patient or therapy area-specific alarm limits. Images of the Dimedâ„¢ fu are available in the section how does it work.

Introduction
The service handles the communication between the study center and the patients automatically.

1) FDA CFR Title 21, Part 11 defines the criteria for electronic records and electronic signatures. It defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

2) GCP (Good Clinical Practice) is an international ethical and scientific quality standard, which aims to ensure the reliability, accuracy, and traceability of research data collected.