As clinical research sites and site networks become more sophisticated, they’ve come to rely heavily on advanced CTMS, eRegulatory and eSOURCE solutions to manage their full set of clinical operations. The size and complexity of data stored in these systems often includes HIPAA protected subject demographic data, medical and medication history, study-specific enrollment data, financial data, regulatory documents, source data, and much more. For many sites, this could include tens of thousands of subject records, hundreds of studies, and many millions of dollars of financial data that 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 when you’ve requested that a full copy of your data be provided to you.
When a clinical research site or site network decides that they would like to use a new system to manage their operations, they must also tackle the challenge of transitioning to a new information system and all the change management that is required to ensure the transition is successful and maintains business continuity. For customers transitioning from a prior CTMS, there is one critical element needed to allow this change to occur without interruption… the historical data that is in their current/legacy system. From an ethical perspective, we can all agree that a software vendor has an obligation to provide a customer with their data upon request, regardless of the purpose; but unfortunately, this is not the position that some CTMS vendors take. When customers request their valuable data, some may only choose to provide a subset of the data on a very relaxed timeline. The repercussions of these practices by CTMS vendors result in a site’s inability to transition effectively or in a timely manner, leading to serious damage to the site’s business operations and financial sustainability.
By not providing all the customer’s data and/or not providing it in a form that can be properly related or migrated, these vendors are essentially holding customers hostage in their system.
Sound unbelievable? Unfortunately, this is happening in our industry today! Shouldn’t sites own their data and have complete access to it whenever they need it? Shouldn’t the focus of research be on the advancement of medicine and saving lives and less on what it means to help a CTMS competitor transition this critical data?
The leadership team at RealTime believes that these business practices are unacceptable and unethical. As such, RealTime expressly states in their software agreement that customers shall receive a complete copy of their data in a usable format upon request.
“We believe that a great product and excellent customer service are what will keep our customers using our system, but if a customer feels the need to move to a different CTMS other than RealTime-CTMS ® then we will provide them with ALL their data, in a timely fashion, so they can successfully transition and continue to successfully operate their business,” said Rick Greenfield, President and Founder of RealTime. “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 to add a Clinical Trial Management Solution into your research site, be sure to ask about each CTMS vendor’s data policies and ensure that you REALLY own your CTMS data and can get it quickly upon request!