For clinical trial sponsors, the process of choosing which eClinical software vendors to engage with for their trials can take months. It is important to gather as much information about potential partners as possible, as these decisions can have a tremendous impact on study success. To help accelerate this process, though, you can look for vendors with a few key characteristics. One such characteristic is the flexibility to scale and extend services as research needs evolve.
Clinical trials change constantly for many reasons, like adding patients, amending protocols, adopting new strategies, and others. So, the technologies, services and processes involved with the trial need to be able to grow as well. Following are some examples that demonstrate the importance of having flexible partners.
When the Study Moves from Early Phase to Late Phase
For early phase studies, there may not be a need for complex solutions from vendors. Many such studies run well with a minimum set of services, such as an electronic data capture (EDC) platform and some relatively simple, on-site data collection strategies. But as studies move from phase to phase, things can get far more complicated. Perhaps the study moves from local to global and requires patient engagement tools available in multiple languages and accommodating diverse cultural needs. Perhaps the study’s target patient population finds it difficult to make physical, in-clinic visits, necessitating the use of decentralized clinical trial elements such as ePRO and virtual visits in order to collect data remotely.
In these cases, your technology partner needs to have the ability to scale to the unique needs of your study. Can you easily begin collecting data from patients via smartphones? Can you easily begin collecting data from wearable devices? If this isn’t relatively simple, or if you have to involve yet another third party to make these things happen, you’re likely not working with the right partners.
When Data is Coming from Multiple, Diverse Sources
Modern study designs are increasingly complex. The technology available is allowing researchers to collect more data than ever using an enormous range of methods. Remote data collection, sensors, connected devices that can transmit data like medical imaging directly into the patient record, the options for where data can come from are almost limitless. While the benefits are obvious – deeper insights into safety and efficacy, the ability to include new endpoints that weren’t possible just a few years ago – there are also challenges.
When a study design calls for mountains of data from multiple collection points, there needs to be solutions in place that can help centralize this data. Solutions, like an EDC, must be flexible to accept data from all of these sources (ePRO, imaging data, labs, wearable devices, etc.) and help researchers organize them into a useful format. Otherwise, the investments made in innovative data collection methods are wasted and the value can’t be fully realized.
The Key to True Flexibility
As complicated as study designs can become, the best partners are always those that make the difficult seem easy. One way they accomplish this is by building solutions that allow sponsors to build out their studies themselves. Intuitive interfaces built on low-code/no-code platforms give you the power to literally drag and drop the study elements you need into your build, whenever you need them. This means you don’t need to bring in a new vendor or consultant to hold your hand every time you want to augment your study designs. It means fewer lengthy and expensive training programs. In this way, self-sufficiency becomes the key to unlocking the flexibility you need to optimize your clinical trials.
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