With the proliferation of inexpensive hosting solutions and the increasingly reliable availability, access to, and speed of the Internet, Clinical Data Management Systems (CDMS) have moved into the mainstream of the investigator market. What was once a dauntingly expensive investment of time, money, and effort is now a relatively straightforward and much less expensive option. But that’s not to say that selecting a CDMS is merely finding a low-cost online solution and entering data.
Defining your needs and matching them to the capabilities of available solutions is still the key to a successful decision. Here are five things to consider when evaluating application solutions for your CDMS needs.
- Features vs. Capabilities
Many vendors can rightly check off the boxes next to a list of features that their solution provides; compliant with 21 CFR Part 11, able to integrate with IVRS/IVWS, data export to post-study analysis tools. But there is a significant difference between features and the ability of a solution to meet a need. A system might have the ability to “export data to post-study analysis” as a feature, but it may only provide a comma separated file which might then require significant massaging and manipulation before it can be used for other purposes.
- Workflow vs. Functional Approach
A CDMS may contain all of the features and capabilities that you need to effectively manage your trial and investigator activities, yet still fail to meet your expectations or address your needs. Why? While the system does what it claims to do, it may not do it in a way that supports your workflow. If your process requires that notifications be sent to certain individuals if lab results are out of range, can the system be configured to programmatically notify those individuals, or does it require you to create a separate communication?
- Communication vs. Reporting
Clinical research is a team activity requiring effective and regular communication among the research team, patients, third parties, and sponsors. Much of the communication is event or result based, meaning that if certain conditions are met, an exchange of information must occur. Good CDMS support system-based communications and integrate voice, data, email, and personal exchanges that occur within the regular workflow of activities and data flow. Systems that only provide reporting capabilities without the integrated communication tools will require more work to ensure that everyone is “kept in the loop.”
- Price vs. Cost
Pricing for CDMS runs from relatively inexpensive hosted solutions to much more expensive installed systems. Even within the hosted versus installed systems options, pricing can differ significantly. But the higher priced systems are not always the most costly systems. The cost of implementation of a CDMS can run anywhere from 2 to 10 times the price of the license and/or hardware. Make sure you understand what the implementation effort entails, whether and how much you will be charged, and the time it will take to implement the solution, and factor the total cost into your analysis.
- Present vs. Future Standards
The continuing evolution of the healthcare landscape most assuredly means that there will be new standards, new requirements, and new regulations to which researchers and investigators must adhere. These emerging and yet-to-be-defined requirements are not only technology oriented, but will include patient records, security, identification, reporting, and a host of other standards. Your CDMS must address the current standards and regulations, and be nimble enough to adjust to these emerging needs.
While almost every CDMS incorporates the expected features and functionality required to support your clinical research activities, there are significant differences in how those systems are designed and implemented. A vendor that can address all of your information needs, on both the administrative and clinical sides of the process, and is flexible to adapt to your way of doing business, is key to a successful partnership.