Clinical trial data is evolving – with broader and more diverse sources than ever. This requires new software applications to help collect and analyze mountains of information. Selecting the right eClinical platform is crucial for ensuring the efficiency, accuracy, and success of your trials. With numerous options available, it can be daunting to determine which platform is the best fit. To make an informed decision, you need to recognize when a provider’s sales folks are making promises their solutions can’t deliver. To avoid making the wrong choice and ending up with vaporware, it’s essential to ask the right questions. Here are ten critical questions to consider when evaluating eClinical platforms.
1. Can You Show Me How the Platform Works?
Technology salespeople and product experts will always be excited to tell you all the wonderful things their platform can do for you. Often, though, sales pitches are much lighter on proof points. There is nothing wrong with asking for demonstrations of the features and functionality you need. If the person presenting their platform can’t provide a demonstration of their technology performing in the ways you need, that is a red flag.
Can the salesperson provide case studies, testimonials, and/or references from other researchers who have successfully used the platform? Ask to see use cases that closely match your needs – e.g., “Do you have any examples of clients that have used the platform in another language?” or “Have you ever had clients that needed to reach patients in rural areas?”
Seeing key features demonstrated and asking pointed questions about the kinds of studies a platform has helped will give you insights into its capabilities and how it performs in real-world scenarios.
2. What Features Are Included?
Understanding the features offered by the platform is crucial. Look for functionalities such as data capture, data validation, query management, reporting, and integration with other systems. Ensure that the platform supports the specific needs of your trials, such as handling complex protocols, accommodating diverse data types, and providing customizable workflows.
Make sure you have a firm understanding of included features – and any features or capabilities resulting in added cost. Some platform providers may charge more to access older data. TrialKit, on the other hand, was built with the mindset that your data is your data, never charging customers to review or interact with their own information.
3. How User-Friendly is the Platform?
A user-friendly interface can significantly impact the efficiency and satisfaction of your team. Request a demonstration to see the platform in action. Pay attention to how intuitive and easy it is to navigate, as well as how quickly new users can be onboarded and trained. The easier the platform is to use, the less time your team will spend grappling with technical issues.
TrialKit was built to allow users to configure the platform easily and quickly to meet their needs, without the need for complex programming. With just a few button presses, researchers can build and deploy a study with multiple arms, using a vast array of data collection methods, and fully accessible from both mobile and web-based workstations. Similarly, users can jump into the TrialKit app and quickly begin working with their data.
4. What Level of Customer Support is Provided?
Effective customer support can make a significant difference in your experience with an eClinical platform. Inquire about the types of support available (e.g., email, phone, live chat), the availability of support (e.g., 24/7, business hours), and the typical response times. Also, ask about the availability of training resources and documentation to help your team get up to speed quickly.
5. How Does the Platform Ensure Data Security and Compliance?
Data security and compliance are paramount in clinical research. Ensure that the platform adheres to relevant regulations and standards, such as GDPR, HIPAA, and 21 CFR Part 11. Ask about the measures in place to protect data, including encryption, access controls, and audit trails. Verify that the platform undergoes regular security audits and has a plan for data recovery in case of an incident.
6. How Does the Platform Work with Other Systems?
Clinical trials often involve multiple systems and tools, so interoperability between systems is essential. Ask about the platform’s integration capabilities with electronic health records (EHRs), laboratory information management systems (LIMS), and other relevant software. Ensure that the platform supports standard data exchange formats, such as CDISC, to facilitate smooth data transfer.
Take an inventory of all the various systems your team uses to collect, monitor, and analyze data. Are you using any decentralized clinical trial (DCT) elements? Make sure the platform can seamlessly pull data in from ePROs, wearables devices, and more. Do your clinical trial sites use different data collection tools? Ask platform providers how their systems integrate the data from all site data entry solutions.
7. Can the Platform Scale to Accommodate Larger Trials or Additional Sites as Needed?
Scalability is a critical factor, especially if you anticipate the need to expand your trials in the future. Ensure that the platform can handle an increase in data volume, additional users, and multiple trial sites without compromising performance. Ask for examples of how the platform has scaled in previous projects to meet growing demands. How has the platform performed as a study moved from Phase I all the way through to post-market research?
8. What is the Real, Total Cost of Ownership?
Understanding the total cost of ownership is crucial for budgeting purposes – don’t get surprised by hidden fees. Ask for a detailed breakdown of all costs, including licensing fees, implementation costs, training fees, and any ongoing maintenance or support charges. As noted earlier, it is important to know exactly what features and capabilities are included in the cost structure that meets your budget. Many platform providers have multiple cost tiers or payment options, e.g., subscription models or fee-for-service. Whatever you decide is the best fit for your organization, make sure to get pricing answers early to avoid frustrating overruns.
9. How Does the Platform Handle Data Migration?
If you have existing data that needs to be migrated to the new platform, it’s important to understand the process involved. Ask about the steps required, the level of support provided, and any potential challenges or downtime. Ensure that the platform can handle data migration efficiently and securely, with minimal disruption to your ongoing trials.
10. What Innovations and Updates Are Planned for the Future?
Technology evolves rapidly, and it’s important to choose a platform that stays ahead of the curve. Ask about the vendor’s commitment to innovation and their roadmap for future updates and enhancements. This will give you confidence that the platform will continue to meet your needs as your requirements and the industry evolve. Solutions built to meet “problems of the day” may not prove agile when new challenges emerge. This is why TrialKit was built with an open API architecture, so it is never locked into the technology issues of the moment and can easily pivot and evolve as the needs of researchers change.
Conclusion
Choosing the right eClinical platform is a critical decision that can impact the success of your research. Asking these ten questions, you can increase your chances of selecting a platform that is reliable, secure, user-friendly, and capable of meeting the specific needs of your studies. By taking the time to ask these questions and thoroughly evaluate your options, you’ll be well-equipped to make an informed decision and set your clinical trials up for success.
For more information about how TrialKit can drive efficiency in your studies while reducing costs, explore study-by-study and enterprise cost models or visit www.crucialdatasolutions.com.
