Mar 19

Clinical Trial Software

The Advantages

The use of clinical trial software will improve efficiency of clinical trials data management, for both small and large studies.

More and more biotechnology, pharmaceutical, and medical device companies as well as research organizations are learning about the advantages of using clinical trial software. This is because data management software will help in many phases of a study. As a matter of fact, those data management software are polyvant: they can assist in aspects from enrollment of patients or volunteers into the study to archiving of completed studies. Also, the use of those software can be beneficial in smaller studies (such as Phase I – with only a few volunteers) or in largers studies (such as Phase III studies – with thousands of participants).

Advantages of using data management software in clinical trials:

1. Allow to reduce the overall duration of clinical trials and cut down on their costs, but this without affecting the quality of the studies

– With today’s economy and the increasing cost of drug development, there is a need to cut down the cost of studies. Using clinical trial software will help create a better and more realistic budget for the studies, reduce the costs, improve productivity by reducing the amount of time needed to complete the studies.

2. Allow consistency by ensuring compliance with HIPAA, FDA or European regulatory guidelines, GCP, 21 CFR Part 11.

– Clinical trial software include major requirements.

3. Allow to invest the effort on the key elements : research and not management

– Regulatory requirements for clinical trials change constently. Clinical trial software are always up-to-date, therefore ease compliance with regulatory guidelines.

4. Facilitate recruitment of patients and volunteers, and important time points throughout the study

– Clinical trial software can be used to facilitate recruitment, screening, scheduling and follow up of patients or volunteers. They also help in being more rigorous with study requirements regarding physicians, institutions, staff qualification and possible difficulties.

Important things to remember:

  • Just like any other computer program, it takes time to implement a computer software. It also takes time to learn how to use it. So before computerizing all your work or switching to a new program, make sure someone in your team is properly trained in using the software.
  • Update and refresh your knowledge with online training.
  • Many clinical trial software can be use remotely. Hence, you do not have to work on a desktop computer.
  • Many data management software will allow you to personalize your trials, and to set up templates that can be used from trials to trials
  • Security features allow protection of data. The system administrator can set access privileges to specific users and studies.
  • Some clinical trial software can work with other programs (such as Microsoft Excel or other databases) and integrate them.
  • Some software system give you the feature to notify you on the status of all ongoing studies, and this, on a single window.

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