Do you REALLY own your CTMS data?
As investigative sites become more sophisticated, more sites are using Clinical Trial Management Systems (CTMS) to manage their site data. This data often includes HIPAA protected subject demographic data, medical and medication history, study-specific enrollment data, financial data, etc. The longer a site uses a system, the more data that will accumulate in their CTMS database. For many sites, tens of thousands of subject records, hundreds of studies, millions of dollars of financial data are all stored in the cloud on their CTMS vendor’s server. But you may be surprised to find out what some CTMS vendors might say if you ask to have a full copy of your data provided to you, even if it is just so that you can have a recent copy of your site’s data.
Some of the most popular CTMS vendors who share the largest part of the market will simply tell you “NO”. One such vendor states that all data can be exported out of their system using the reporting section. But, a full export would take many hours, require dozens of separate custom report builds and would still not provide ALL of the data in the system.
Another popular vendor will ask you “why?” If you tell them it is because you would like to move your data to another system, then they will not send the file. In fact, this particular vendor has an agreement that you must sign in order to receive a copy of your data. This agreement requires the customer to covenant that they will not use the data to move to another system. Without that agreement they will only send you your data 30-45 days after the software contract is cancelled. Even if you request a copy of your data for back-up purposes only, they will not send you a full data set, only a portion of the data.
These vendors are essentially trying to hold customers hostage in their system. Without giving customers their data, they can’t leave.
Sound unbelievable? At the very least, it is definitely a horrible business practice. Shouldn’t sites own their own data and have complete access to it whenever they need it?
There is one CTMS system on the market that feels that these business practices are unacceptable, RealTime-CTMS™. RealTime expressly states in their software contract that the customer shall receive a complete copy of their data upon request. Rick Greenfield, CEO of RealTime Software Solutions, states, “We believe that a great product and excellent customer service is what will keep our customers using our system. If one of our customers feels the need to move to a different CTMS other than RealTime-CTMS™, then we will help them get their data moved over. It’s their business and we are here to support the sites, not hold them back from the tools that they feel are necessary to achieve success.”
If you are looking into a CTMS for your site, be sure to ask about each CTMS vendor’s data policies and find out if you REALLY own your CTMS data!