Navigating the Complexities of Selecting a Vendor in the Crowded e-Clinical Marketplace
Searching for a new e-clinical vendor is challenging as the market is highly commoditized with multiple vendors with products that seemingly perform similar tasks, particularly in the Electronic Data Capture (EDC) space. The volume and variety of products and solutions makes it difficult to easily assess and evaluate the differences; yet, working with the wrong vendor can cause financial and time-related complications in a clinical study.
To meet the demands of today’s complex clinical trials requirements, CROs and sponsors need solutions that can mold to any research requirement, while also providing the flexibility to build and configure studies affordably by themselves. Every clinical trial requires several different systems. At the core is EDC, which is the hub of all the clinical information. Other key components include Interactive Response Technology (IRT) to randomize subjects and manage drug shipments, and the Clinical Trial Management System (CTMS) governs all the activities within and across the studies allowing management to monitor progress. For the larger vendors, these are typically offered as three integrated, but disparate systems, while smaller vendors may provide only one component of the eClinical solution. In such instances, data resides in separate databases that need to be programmed and maintained which demands more resources and escalates the cost. Choosing a comprehensive solution that can be set up within days and streamlines the entire clinical trial process can save time and improve the eClinical experience.
In addition to considering the breadth and integration of core capabilities, it is also critical to consider key factors including speed, responsiveness and flexibility when choosing a new solution.
Speed
Building your study in a timely fashion is crucial to its success because any delays during the process could be costly. And a shorter build time may save you money. Depending on the vendor, you could be promised a study build timeline anywhere from 6-12 weeks.
It will be tempting to opt for the EDC vendor that promises you a study build timeline of 6-8 weeks; however, be sure to check the deliverables. The timeline may be attractive, but you might only have the bare bones of your study at the end of eight weeks. This would require you to do more work, thus costing you more time and money. In that case, it’s not truly an eight-week turnaround.
Responsiveness
In clinical trials, time is of the essence. It is critical to have a vendor that is easy to contact and responds in a timely manner. But this, too, can vary by vendor. Some promise to respond same-day or next business day, even if just to acknowledge your message and provide an answer at a later date. Other vendors may take up to a week to respond. If your vendor doesn't respond quickly, your questions will begin piling up and it may cause delays in your study.
There’s also a drastic difference in timelines for making changes to your study. While the vendor who acknowledges your message the same day ensures you they’ll make the change to your study in a week, the vendor who took nearly a week to respond can't make the change that quickly. If they put your request on a list with others, it might take several weeks to make the same change to your study.
Flexibility
You likely have an idea of how you want – or how you need – to build the study; you just need help building it. So, don’t settle for a vendor that tells you what to do. Find a vendor that is excited to hear what you bring to the table — one that provides you with options and guides you through the process to build the study you want. Choose a solution that flexes with the needs of study, versus requiring the study to bend to the needs of the software. Not only will it be a better experience, it will result in a better study.
Similarly, if you have a unique need for your study, make sure you find a vendor that is willing to get creative. Some vendors may simply tell you it's impossible to make a certain customization happen, while others view it as an opportunity to problem-solve and try something new. A vendor willing to go the extra mile to meet your needs is extremely valuable.
In addition to identifying a vendor that meets your current needs, it’s important to choose a vendor that is a true partner and evolves with you in the future. As technology continues to advance and data sources become more accessible, it will open up new opportunities and models for clinical trials. At the same time, the rapidly changing development landscape may not favor frequent switching between eClinical vendors. Understanding the near and long-term development goals of your vendor can help you determine if they have the makings of a long-term partner.