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Klindat: The ePRO Application for Clinical Trials

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

30 August, 2023

Klindat La aplicación ePRO para ensayos clínicos

You can visit klindat.com to learn more about the Klindat ePRO software

In recent years, the participation and voice of patients have gained prominence in the field of clinical research.

Clinical trial sponsors and investigators are now more aware of patients’ needs and concerns, and these are considered when designing studies.

For example, in the initial phases of a clinical trial, in its design stage, it is common for patients to be consulted regarding the visits and tests to be performed.

In this article you will learn about:

In addition, more and more data are being collected on patients’ quality of life and forms are being used to capture how they feel on a personal level.

Moreover, the coronavirus pandemic resulted in the need for patients to communicate information in clinical trials remotely, due to the limitations to travel to hospitals.

Therefore, the centrality of patient participation, together with the need for patients themselves to provide data in clinical trials, has contributed to the emergence of new technologies that make these activities possible.

New web applications that allow patients to report data in clinical trials remotely are known as ePRO (electronic Patient Reported Outcomes) systems.

The essential idea is that these are results provided by patients through electronic means.

In response to this need in the clinical research sector, the company Zlynger has developed the innovative Klindat ePRO tool, which will be discussed below.

What Is Klindat?

Klindat is an ePRO software that allows direct transmission of data by patients in clinical trials.

It is a very easy to use application and patients can access it with a username, password, and web browser.  

What Are the Features and Benefits of the Klindat ePRO Software?

The Klindat ePRO application is characterized by its simplicity, which makes it very user-friendly and intuitive, being accessible via the Internet (no additional hardware or software needs to be installed for it to work). 

This innovative ePRO tool is compatible with multiple devices and browsers.

Hence, it can be accessed from anywhere with Internet, using a PC, laptop, or mobile device. 

Klindat is a robust software that ensures data security and integrity, including advanced access control mechanisms, SSL encryption, and daily backups.

The system guarantees high service availability and complies with international regulations (e.g., HIPAA, GCP, and 21 CFR Part 11). 

The Klindat ePRO platform has functions that facilitate the data management tasks that system administrators must perform.

It is a scalable solution for studies of any size —from small academic studies to large commercial clinical trials— and offers remarkable flexibility for streamlined workflows. 

How Is the Klindat ePRO Software Contracted and What Is Its Price?

The contracting model of the Klindat ePRO system is very simple and clear. 

First, there is an initial cost of specification, implementation, and testing of the application (start-up).

The price of this initial stage depends on how many data forms are needed and ranges from US$ 3,000 to US$ 9,000. 

Second, the use of the application entails a monthly fee based on the number of patients that will use the system.

Depending on the size of the project, this fee can cost between US$ 300 and US$ 1,000 per month.

Klindat’s billing scheme is simple and transparent, which allows clinical trial sponsors to easily plan their budgets.

Conclusion

Clinical research has placed patients where they belong: center stage.

The feelings and concerns of the people who participate in clinical trials must be taken seriously into account.

ePRO software solutions have been designed to enable patients to transmit information directly to clinical trial databases.

The Klindat ePRO tool is a simple and affordable option that will meet the expectations of the most demanding sponsors.

You can visit klindat.com to learn more about the Klindat ePRO software

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com