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Klindat: EDC Software for Clinical Trials

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

28 July, 2023

Klindat Software eCRF para ensayos clínicos

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

Electronic Data Capture (EDC) systems are essential tools for data management in clinical trials.

Although until recently clinical trial data were collected on paper, most studies are now using web-based EDC tools, given the multiple advantages offered by Internet-based communication.

In this article you will learn about:

There are many EDC solutions on the market today, with various functionalities and price ranges. On this occasion, we will look at the features of the Klindat EDC system, developed by the company Zlynger.  

What Is Klindat?

Klindat is a web-based Electronic Data Capture software used for the collection, cleaning, and export of data generated in a clinical trial.  

It is a very versatile EDC tool, which is why it is not only used in clinical trials, but also serves the needs of patient registries and post-authorization studies.  

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

Klindat is an EDC tool that significantly optimizes the collection, cleaning, and processing of data in clinical trials. 

This Electronic Data Capture system can be used in clinical studies in any therapeutic area, such as oncology, cardiovascular, metabolic, central nervous system, dermatological, infectious and respiratory diseases, among others. 

The application stands out for its simplicity, which makes it intuitive and very easy to use, being accessible via the Internet (no installations required) and compatible with multiple devices and browsers.

Klindat is a highly secure and reliable EDC platform including access control mechanisms, SSL encryption, and daily backups. The system ensures high service availability and complies with HIPAA, GCP and 21 CFR Part 11 requirements. 

The platform has powerful features that facilitate data management tasks and customizable reporting tools. It is scalable to studies of any size and offers great customization potential as well as complete design flexibility for optimized workflows. 

If required, cloud storage can be provided for uploading documents (Word, PDF, etc.) and large amounts of files (e.g., images in DICOM format), including image viewers. 

Klindat’s team is dedicated to the needs of each client by providing a custom-made EDC system and qualified technical assistance always close to the end user. 

Klindat is used by pharma and biotech companies, research groups, non-profit organizations, clinical research organizations (CROs), hospitals, and institutes. 

How Much Does the Klindat EDC Software Cost?

The Klindat EDC contracting scheme is simple: an initial implementation cost based on the number of data forms and a subsequent monthly subscription that will depend on the number of patients to be enrolled in the study. 

As a guideline, the cost of the initial building of the EDC platform, depending on the complexity of the study, is around US$ 4,000 – US$ 12,000, while the monthly subscription is in the range of US$ 300 – US$ 1,200 per month (depending on the number of patients). 

Conclusion

The Klindat EDC software is a very interesting option for clinical trial sponsors. It is a flexible and user-friendly tool that offers all the operational and security guarantees required by the clinical research industry. In addition, it is available at an affordable price, which is a great advantage for studies with a limited budget.

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