The process of starting a clinical trial involves the careful management of various stakeholders, all of whom present unique challenges. Therefore, automating as many facets of the study is vital to ensure organization. Fortunately, advancements in technology have allowed for these capabilities.
Electronic data capture (EDC) is one such advancement. Implementing this platform provides the potential to drastically enhance your clinical trial. EDC allows for remote data collection and storage, removing the need for traditional hardcopy systems for trial management.
Read below to learn more about how EDC can benefit your study, and what you should look for when shopping vendors.
Cost-effectiveness is paramount as medical device or drug development is a complicated and expensive process. Therefore, your budget should be clearly outlined prior to shopping vendors.
In terms of pricing, EDC platforms run the gamut. The software can range from free of charge to quite expensive. Therefore, implementing an EDC platform can take much consideration when determining a fair price.
When choosing platforms, it is important to compare and contrast pricing across multiple vendors, even after you believe you have found a service that best fits your study. Since cost can vary greatly, it is important to realize that support may as well. More cost-effective EDC platforms can offer little, if any, support whereas more expensive vendors may boast ‘round-the-clock solutions. Understanding this concept can help you determine just where you fall on the cost spectrum, and allows for appropriate comparison of vendors that offer similar services.
One of the many benefits of utilizing EDC is the idea that money is saved long-term. Overhead is minimized, particularly with multi-site studies because manpower is not required for every step of data collection as with paper-based methods. Furthermore, data accuracy is improved through automation, thus limiting time spent for document verification or reviewing transcription errors.
2. Flexibility of the System
Usability is desirable. With so many moving parts, your clinical investigation will constantly evolve. Thus, choosing an EDC platform that adapts along with your needs is critical.
Unique challenges are certain to occur throughout the course of your study, so your platform must be able to rise to the occasion. Unfortunately, many EDC platforms are not flexible in this regard.
If your EDC platform isn’t user-friendly, data collection can be just as cumbersome as in paper-based methods. EDC software should be intuitive, simple to understand, and easy to configure. If your EDC platform is difficult to set-up, a number of issues may result as a poor design can lead to frustration for all parties with blame placed squarely on the platform. When the solution to a particular issue you face remains unclear, support should be available to help you work towards a resolution together.
Keeping this in mind, technical support is likely necessary to budget for when choosing a vendor. Be certain to delineate precisely what capacity help exists, as well as when it is available to you.
Having to suspend enrollment to resolve technical issues can negatively affect your budget, delay the timeline, or ultimately derail your clinical trial. Make sure you choose a vendor that can grow with your needs.
If your EDC platform can’t accomplish what it’s supposed to, what’s the point? Conducting clinical research is plenty challenging without the added headaches of an unreliable EDC. To maximize the potential benefits, your EDC platform must perform.
A cursory internet search can start you down the right path, but only so much information can be obtained from a website. Too much is at stake to rely on this level of inquiry. Rather, your survey of the various EDC platforms currently available should generate pertinent questions for the vendors on your short-list.
Remember to compare and contrast vendors based on the needs and budget of your study. Be sure to inquire about their design options, the ability of data collection formatting to be applied across multiple protocols, and the available edit checks that can be built into your platform. Additionally, it is important to gain knowledge regarding precisely how data can be obtained, stored, and exported. Lastly, be sure to learn about the types and number of studies for which particular vendors build platforms for each year. The average number of studies' services rendered for each year can be telling. This number is unlikely to grow for vendors who consistently underperform.
If these questions can’t be easily answered, then that vendor may not be a preferred candidate to provide solutions for your clinical trial.
4. New Module Integration
It is important to be clear with regards to the integrative capabilities of the platform you choose. It can be largely inefficient to partner with a vendor that requires a substantial rebuild for each new study because their platform lacks the ability to apply existing modules to new protocols.
Besides being redundant, this can also be an expensive endeavor because many vendors require payment for additional programming. Thus, when considering vendor pricing, module integration should always be part of the dialogue.
Opt for a vendor that offers an all-in-one solution, like MedNet, as integration is often necessary and should be seamless. Clarifying these points up-front can avoid unnecessary expenditure of resources.
5. Platform Updates Frequency
Find a platform that performs two or three software updates each year as technology can become stale. Major advancements have been made in this regard since EDC was first introduced as a means to stay on-trend.
However, updates are not only necessary to correct technical glitches or implement module enhancements. The vendor must maintain compliance requirements throughout the duration of your clinical trial. Failing to do so can render collected data unusable, and lead to wasted time, effort, and capital.
Inquire about update frequency prior to choosing your vendor. In addition to periodic application improvements, appropriately designed interfaces should allow for regular maintenance to ensure adherence to industry and regulatory standards.
6. Customer Service
Inquire about available support when choosing an EDC vendor. As previously mentioned, the level of support may allow for variation in pricing, as low-cost systems likely do not offer this service.
Nonetheless, this facet of your clinical trial can prove to be indispensable. A myriad of challenges are sure to arise as the investigation progresses, many of which may go beyond the scope of practice of team members who do not specialize in EDC. Thus, it becomes vital to have access to experts when you are in need, to avoid any unnecessary delays or wasted resources.
Once again, it is important to compare support services offered to users among multiple vendors to suitably determine cost effectiveness for your trial’s specific needs.