Global Clinical Trials: 5 Essential eClinical Considerations

Global Clinical-trials-5-essential-eclinical-considerations | Medrio

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 trials, and overall greater transnational collaboration. Take a look at this:

• CRO outsourcing is now the norm. This year it’s predicted that 50% of trials of all phases will be outsourced overseas this year.

• While the US and Europe continue to grow and innovate, Asia-Pacific (APAC) has emerged as a leading research hub, with more than 450% growth in the number of clinical trials since 2010. Australia is now a hotspot for Phase I research and has invested $56 million into an impressive CAR-T cancer treatment center.

• The first virtual clinical trials conference took place last year. Many industry leaders anticipate that this trend will shape the future of how we engage more diverse patients and develop groundbreaking treatments.

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:

1. The ability to instantly share high-quality data across long distances

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. Here’s how:

• Sites can capture source data remotely in real-time. That means teams can instantly review data, spot adverse events, and make crucial decisions faster.

• DDC reduces monitoring time by 50% and transcription errors by 90%.

• By reducing the monitoring burden, you’ll more easily find qualified staff in up-and-coming regions.

2. Features to reduce patient burden

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:

• Since 70% of trial participants live 2+ hours away from a trial site, leveraging ePRO to let them enter some or all data remotely can facilitate recruitment and reduce dropout rates.

• Harnessing multimedia tools like eConsent keeps patients informed and engaged throughout the trial, improving communication between site staff and participants.

3. Built-in localization

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.

• Especially when collaborating with countries with different regulations, you want to have peace of mind when it comes to compliance.

• If you’re working with teams who work using different languages, this feature promotes clarity and smooth communication.

4. Regulatory peace of mind

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.

• Make sure the organization you choose is up to date on regulatory standards in growing research hubs. For example, we at Medrio just set up servers in China to meet their stricter data compliance standards.

• The organization you choose should also be up to date on MDR and all major upcoming regulatory changes long before they go into effect.

  • 5. Offline data capture

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.

• Flexibility in collecting data is becoming more important. Not having to worry about Internet connectivity takes another concern off your plate.

• A customer of ours conducting cholera research in Yemen was able to collect data directly from patients’ homes without the internet. When researchers later synced the data to the EDC, the collaborating team in the UK was able to see and evaluate the data instantly.

With the quickly-changing clinical research landscape, we at Medrio want to ensure you get the best-fit solutions that empower your team and help you serve populations in need. Knowing what to look for and what questions to ask is essential to selecting the right eClinical provider for you.

If you’re interested in reading more information about evaluating an eClinical service provider, you can read more here.