Selecting an eCOA Vendor to Best Fit Localization Needs

One of the main challenges for pharma/biotech companies regarding clinical trials is prolonged eCOA study start-up. 

It is paramount to choose the right eCOA platform for each study. Sponsors must consider the study’s specific needs, such as user-friendliness, compliance, and configurability. The investment of both time and money, not to mention protecting and upholding the integrity of the data collected, is critical when seeking regulatory approval and confirming drug safety and efficacy. A platform’s ability to handle localized content should also be a key component when determining which platform is the right fit for each study. 

eCOA Platform Localization Considerations for Global Clinical Trial Success

One of the key considerations when choosing an eCOA platform should be localization capabilities, to ensure the study reaches patients of diverse backgrounds. The 2020 global pandemic forced an even faster adoption of digital-centric trials and created an increased need for eCOA solutions to be rapidly deployed. As of 2023, the global eCOA and eSource market was valued at $48 billion, with continued rapid expansion at an 8% CAGR over the next 10 years. By 2033, the eCOA and eSource market size is estimated to be $104 billion, an increase of 117% since 2023.¹  

Due to the increased demand expected over the next decade, the successful administration of COAs in an electronic format is a key component for successful future drug development. In order to ensure timely study start-up, in conjunction with the integration of eCOAs, greater coordination with specialized language service providers (LSPs) will prove to be greatly beneficial to avoid delays or last-minute changes. 

From a localization perspective, a best-in-class platform will include multiple key functionality requirements related to four key pillars:

1. Content management: Evaluation of how content is managed in the app, including import/export features and string metadata
2. Internationalization: Preparedness of the platform to host content in other languages
3. Post-localization testing: Features for automated screenshot capture and review for enhanced user experience
4. Content reusability: Functional library with modular string content for future reuse

Developing or partnering with platforms that are aligned with localization best practices and these key pillars is imperative in not only meeting deadlines but also ensuring quality.

Automation and Library Capabilities

The good news is that there are ways to achieve faster time-to-market. Two key components of drastically decreasing eCOA timelines are leveraging automation technologies and library capabilities.

1. eCOA automation refers to a screenshot generation process that removes the manual screen capture component of both English and localized eCOA screenshots. By introducing screenshot automation into the eCOA workflow, sponsors can achieve a 40%+ reduction in eCOA localization timelines. 
2. Reuse and eCOA library functionalities allow sponsors to utilize previously translated electronic content. It is important to note that not all eCOA libraries are created equal. This phrase is sometimes used as a catch-all for any sort of reusable process, which can often be manual and time intensive. It’s important to choose a vendor with an eCOA library that fulfills certain technical requirements, such as modular string management, from a localization perspective. 

Case Study: Screenshot Review Automation for Faster and Streamlined Timelines

In 2023, one of the world’s leading pharmaceutical companies achieved over 40% faster timelines by placing automation at the forefront of the eCOA vendor selection process. By working with an eCOA vendor with screenshot automation capabilities, this pharmaceutical company reduced the average number of screenshot review rounds during the eCOA workflow from three to one to two rounds. As a result of the overall time reduced during screenshot review, in addition to reduced project management time due to eCOA vendor automation efficiencies, this pharmaceutical company found a solution to eCOA timeline challenges.

Case Study: Top 10 Pharma Utilizing Content Reuse

Another top 10 pharmaceutical company leverages app localization technology to build and maintain its own eCOA library with complete reuse and library functionalities. All of the eCOA content within this platform is study agnostic, and generic/UI content is stored and translated as content is added and/or updated. In leveraging this technology with successful library hosting capabilities, timelines have been cut in half, as previously localized eCOA content can be leveraged without manual text manipulation. In this workflow, there is no need for re-review, given the technology works in a way that is suitable for localized content to be reused without any manual manipulation. In addition to timeline savings, this pharmaceutical company is achieving upwards of 60% in cost savings from reuse capabilities alone.

Considerations

To further the goal of shortening the lifespan of study start-up timelines and optimization, it is important to include localization considerations in the eCOA vendor selection process. Without including these considerations, it’s possible to face delays in your study timelines and quality concerns, ultimately risking compliance, higher associated costs, and more internal burden. By prioritizing localization capabilities and leveraging automation technologies during the vendor selection process, sponsors can mitigate these risks and confidently continue to drive successful clinical trials.

TransPerfect launched the eCOA LingCert Accreditation program to aid sponsors throughout the eCOA vendor evaluation process. The accreditation is designed to provide sponsors with more transparency in eCOA platform localization capabilities surrounding the four core pillars of content management, internationalization, post-localization testing, and content reuse. To start your journey in achieving faster study start-up timelines, check out our recommended capabilities checklist here, get in touch with us directly to learn more about our eCOA LingCert Accreditation program. 

References

1. “eCOA, eSource & Clinical Trials Market.” Fact.MR, May 2023, https://www.factmr.com/report/4042/ecoa-esource-clinical-trials-market