Which Electronic Data Capture System Should I Use?

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

10 February, 2019

There are several types of electronic data capture (EDC) solutions that can be used to manage data in clinical trials.

The selection of the data management tool will depend on the size of the study and the functionality needed. It is very important that a detailed requirements analysis be done to determine these prior to making decisions on software.

Possible constraints on choices will include cost and the possibility to customize the features, forms and fields of the EDC system.

Most large trials will require the use of software with powerful data handling features. Smaller studies could be managed using a smaller database system. It is important to carefully review the features and to select the product that will most closely meet the requirements of the project.

Some features that may be important in selecting an EDC tool are:

  • Data entry screens easy to navigate
  • Support for direct data entry and data verification
  • Ability to issue automatic and manual queries
  • Built-in audit trail mechanism
  • Data backup and recovery tools
  • Solid security features
  • Training and technical support by the supplier

When selecting an EDC solution, there may be no single data management system that meets all of the requirements. If this is the case, there may be a temptation to try to develop an in-house system and not use any commercially available package.

This may seem the best option to provide the required functionality but is probably not realistic in the majority of situations.

The full development of a clinical data management application is a tremendously resource consuming work, and usually out of the scope of trial sponsors.

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