How many comprehensive IT solutions, and more specifically those that relate to the clinical trials space, have the ability to be implemented on-premises or hosted in the cloud, in just a matter of weeks? Not many. When it comes to clinical trial management systems (CTMS), there are even fewer.
ASCEND, an Oracle Siebel CTMS accelerator, is pre-configured to meet the rigorous requirements life sciences companies have. From subject statistics to the tracking of protocol deviations, electronic signatures and trip report management features, the system typically meets most requirements out-of-the-box. Don’t forget, it was designed with the most commonly-requested features in mind. And because the new Siebel CTMS platform is so highly configurable, ASCEND can continue to adapt to your company’s evolving needs as it updates its processes, aims for improved compliance, and more rigorous quality management. Oh, the solution is fully validated and 21 CFR Part 11-compliant, too!
It’s not uncommon for system implementations to take a year or longer, especially in our highly regulated space. Reducing the need to add enhancements, combined with the option to host in the cloud, can provide a significant cost savings and shortened implementation timeline.
As you compare the different CTMS solutions in the marketplace, make sure you ask yourself some basic questions:
- Does it have the features I want? If not, what will it take to get there from a cost and time perspective?
- What are my deployment options?
- What does the implementation timeline look like?
- Is the solution validated?
- Is it 21 CFR Part 11-compliant?
- Are there companies like mine already using the system?
Based on just a few questions, you may be able to narrow down the list of contenders and begin a more detailed evaluation process with demonstrations and the ability to test it out for yourself in a sandbox environment.
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