Build or Buy a CTMS: Consider Data Security

Lisa Haddican
January 22nd, 2014

Whether you’re moving from spreadsheets or have outgrown your current system, deciding whether to build or buy a clinical trial management system (CTMS) is a big decision. There are many factors to consider, including the true cost of each type of system, functionality, and more. Another very important consideration is how the data will be handled to ensure privacy and security.

Let’s take a closer look at a few questions to consider that can help you determine which type of system can properly support the privacy and security of data.

Privacy & Security of Data: 3 Questions to Consider

For sites, an important motivator for moving away from paper-based processes or the use of spreadsheets is compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). A clinical trial management system can be a unifying force and it helps centralize data, which in turn, can be an important step for ensuring control over the privacy and security of the data contained within it.

Questions to consider include:

1) Expertise of the software developers: Do the developers understand the nuances of protected health information (PHI) and HIPAA?

2) Access to data: Will system users have access only to data that is appropriate to them?

3) Infrastructure requirements: Does the software and infrastructure meet the rigorous requirements for safeguarding protected data?

Whether it’s a homegrown or vendor-provided system, it’s imperative that the CTMS can properly support the privacy and security of the data entered. Of course, there are many other factors to consider when deciding whether to build or buy, such as maintenance, training and support, reporting capabilities, and much more. For a comprehensive list of considerations, download our free eBook, “Build or Buy a CTMS? A Guide to Choosing the Right Option for Your Site.”


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