Over the past 10 years, the clinical trial industry has transformed dramatically. Globalization has taken off, giving rise to Contract Resource Organization (CRO) outsourcing, decentralized clinical trials, and overall greater transnational collaboration.
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With geographic barriers disappearing, there are unprecedented opportunities to innovate and revolutionize public health. However, there are also potential new challenges in stakeholder communication and tightening global regulations. MDR, the comprehensive medical device regulatory overhaul, goes into effect across Europe in just a few months. China, India, and Australia are also shaking up their regulations, underscoring greater patient safety and product quality.
With all these shifts, what are the essential eClinical considerations when evaluating eClinical service providers in this new decade?
Here are 5 things your software needs to have:
With regulators highlighting patient safety and data quality, research teams need tools to eliminate the chances of mistakes or delays. Additionally, flying monitors internationally is costly, and communicating with teams on different sides of the globe can be challenging. Tools like Direct Data Capture (DDC) can help.
With patient issues ranking as the #1 obstacle to getting trials done on time and on budget, tools to facilitate trial participation are a must. More and more research teams are incorporating elements of decentralized research to support patient centricity. We’re supporting this movement with our ePRO, eConsent, and Direct Data Capture platforms:
For those who are not familiar, software localization is the process of adapting or translating a program to fit a specific area’s language, culture, and legal requirements. Depending on the case and country, localization can require modifications to the user interface, images, documentation, and other features.
Compliance is always a top concern. When conducting trials globally, there are several key features your eClinical software should have. You want to cover all your bases and ensure there are no snags when it comes to regulatory submission.
In rural areas and parts of the developing world, a stable Internet connection isn’t a sure thing. A final feature you may want to check for when evaluating eClinical service providers is the ability to capture data offline when they’re no internet connection, then to sync it with the EDC once a connection is reestablished.
With the quickly-changing clinical research landscape, we want to ensure you get the best-fit solutions that empower your team and help you serve populations in need. Our Decentralized Trials Solution can help you address the challenges we are faced with today.