USA: +1 617 939 9497 | UK: +44 2039 962936 | EU: +34 607 939 266 info@sofpromed.com
Select Page

Klindat: eCRF Software for Patient Registries

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

28 July, 2023

Klindat Software eCRF para registros de pacientes

If you need eCRF software for patient registries, you can contact us at info@sofpromed.com

Patient registries have been used for many decades in the field of clinical research.

Today, patient registries continue to play a highly relevant role in better understanding diseases and developing new treatments.

Essentially, a patient registry consists of a list of cases of people affected by a specific disease, for whom their health data and the treatments received are collected.

In this article you will learn about:

The methodologies and means used to create and analyze patient registries have changed over the years.

Decades ago, patient registries were implemented by clinical researchers using such elementary means as paper and handwriting, before the advent of new Internet-based technologies.

However, with the progress of informatics and the arrival of web technologies, patient registries have evolved into advanced databases built, refined, and analyzed with much greater efficiency and accuracy.

More specifically, patient databases for clinical research purposes are nowadays implemented by web applications known as Electronic Data Capture (EDC) systems or electronic Case Report Forms (eCRF).

More detail on how eCRF software tools optimize the creation, cleaning, and analysis of patient registries will be explained below.

What is a patient registry?

Although it has been already discussed in the introduction of this article, let’s dig a little deeper into the concept of a “patient registry”.

A patient registry can be understood as a database that includes a list of subjects with their clinical data, including demographic data, medical history, diagnosis, treatment, and follow-up information.

Patient registries for clinical research purposes are usually constructed by grouping subjects who have a common characteristic, such as a particular type of disease.

For example, there are cancer patient registries, which usually include specific cohorts of patients with specific tumors.

Doctors and clinical researchers use the data collected for a specific cohort of patients and perform drug safety, survival, and treatment efficacy analyses, among other studies.

How is a patient registry designed?

A patient registry is designed based on the research objectives and the types of data to be collected and analyzed for a specific clinical study.

Typically, the research objectives are detailed in a study protocol, which must be approved by a clinical research ethics committee.

Once the protocol has been written and approved, containing the medical tests and clinical information to be analyzed, the next step is to work on specifying the forms and data fields to be evaluated.

The tool normally used to collect data from a patient registry is known as the Case Report Form (CRF), which can be implemented in paper format or as an electronic application.
You can find some recommendations for the proper design of the forms and fields that make up a CRF below.

Good practices in the specification of a patient registry

It is very important that a CRF is well designed from the beginning. The coordinating research team should think very carefully about the information they will need for the research.

What data are really needed in the patient registry? How should the data fields be specified? How well will hospital investigators know how to interpret what information is being requested, or perhaps some fields are confusing?

Based on experience, the following tips will prove very beneficial:

    • Do not request more data than you truly need. It is always tempting to ask for a lot of information when designing a patient registry. However, doing so is not a good practice. Firstly, much of the information may never be used and, secondly, entering data into a registry puts a strain on investigators, who usually do not have spare time during the day.
    • Specify questions clearly and unambiguously. The person designing the CRF for the registry may know very well what he or she needs and what each field means, but it cannot be assumed that everyone will be so clear. It is not uncommon for people inserting data into forms to make mistakes because they have not correctly understood what information is being requested.
    • Avoid free text fields. A highly recommended practice when designing a CRF is to avoid the use of free text fields. When clinical information is collected in free text form, each person will enter the information in a different way, and this will reduce homogeneity and make analysis difficult. Statistical analyses are based on standardized and consistent data, and the use of free-text fields does not contribute to this. It is therefore much better to use fields that do not allow variability, i.e. fields with selectable predefined answers (e.g. drop-down menus).

    What is an eCRF software application?

    An eCRF software application is a web-based platform that serves to manage data from a patient registry —and other types of clinical studies— in a highly efficient way, replacing paper.

    eCRF software applications have become a global standard, and paper-based CRFs are gradually disappearing.

    What advantages do eCRFs offer for patient registries?

    eCRFs offer several advantages when implementing a patient registry, among which the following are highlighted:

      • Speed of data collection: Using a web application allows for agile insertion of clinical information. As soon as users enter the data in the platform, they are available for review.
      • Saving in courier shipments: The use of an eCRF completely eliminates the mailing of paper forms, which generates savings in courier costs and avoids efforts to organize such mailings.
      • Agility in data cleaning: Data cleaning is performed efficiently when using an eCRF since queries can be issued within the same eCRF system and hospitals can resolve them easily by accessing the platform.
      • Security and traceability of information: An eCRF guarantees a series of security mechanisms that preserve the integrity of the data. At the same time, these systems integrate audit trails that create a record of all activity performed on the platform (including who has accessed and what data has been entered or modified).

      Which eCRF is recommended for a patient registry?

      There are numerous eCRF solution providers on the market. It is important to understand the needs of each clinical study when purchasing an eCRF, and you should also take into account the available budget.

      Sofpromed offers eCRF solutions, designed for the specific needs of each type of research. In particular, we have extensive experience in providing eCRF systems for patient registries in multiple therapeutic areas.

      For patient registries Sofpromed recommends the use of the eCRF Klindat, manufactured by the company Zlynger. The Klindat eCRF stands out for its simplicity and flexibility to adapt to any type of patient registry. In addition, it is an affordable software for both commercial and academic sponsors.

      This list provides a summary of the main features of the Klindat software:

      • Simple: Clear, intuitive, easy to use.
      • Accessible: Web-based, no installation required.
      • Secure: Access control and SSL encryption.
      • Reliable: Daily backups, high service availability.
      • Compatible: Works on multiple devices and browsers.
      • Compliant: HIPAA, GCP and 21 CFR Part 11 compliant.
      • Powerful: Data and reporting management tools.
      • Scalable: Studies of any size.
      • Customizable: Customized logo, URL, colors and forms.
      • Efficient: Optimized workflows.

      On the other hand, Sofpromed not only supplies the eCRF solution as such, but also offers various data management services including specification, implementation, testing and validation of the eCRF, as well as other subsequent services such as data cleaning and statistical analysis.

      Conclusion

      Patient registries provide very important data that contribute to a better understanding of diseases and the development of new treatments.

      Researchers and sponsors working with patient registries should use eCRF tools adapted to their studies that ensure the quality and security standards required by the industry, within the available budget.

      Sofpromed recommends the use of Klindat eCRF, an ideal tool for patient registries, which can be purchased at a very competitive price.

      In addition, our team offers specialized data management and statistical programming services, thus proposing a complete offer that covers all the needs of a registry study.

      If you need an eCRF patient registry software, you can contact us at info@sofpromed.com

      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 

      You may also be interested…

      What Is the Actual Cost of a Clinical Trial?

      What Is the Actual Cost of a Clinical Trial?

      Check the Clinical Trial Cost Calculator here and calculate your trial budget in seconds! Please contact us and we will send you a ballpark clinical trial quotation within 48 hours. Click here if you want to download a full clinical trial quote in PDF Biotechnology...

      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