Empowering Pharma Clinical Trials: Octalsoft’s ePRO Solution for Phase 3 COVID-19 Research

The COVID-19 pandemic challenged the pharmaceutical industry to innovate rapidly and efficiently. In this high-stakes environment, a leading pharmaceutical company in Canada approached Octalsoft to implement an ePRO (electronic Patient-Reported Outcomes) solution for a Phase 3 clinical trial in infectious diseases. The urgency and complexity of this project demanded a cutting-edge, flexible, and robust solution to ensure trial success.

Client’s Challenges:

1. Time-Sensitive Deployment: With the global urgency surrounding COVID-19, the client required the solution to be deployed within the shortest possible timeframe.
2. Seamless Virtual Collaboration: Effective virtual collaboration across stakeholders in different time zones was essential.
3. Multi-Lingual, Multi-Regional Scope: The solution needed to cater to over 1,000 subjects across diverse languages and regions.
4. Hybrid Model Flexibility: A combination of paper and electronic diaries was requested for user convenience.
5. Mid-Study Adaptability: Anticipated major mid-study changes required a highly adaptable IWRS (Interactive Web Response System) and ePRO application.
6. Mobile Compatibility: A patient-friendly mobile application was needed, compatible with both iOS and Android platforms.

Octalsoft’s Solution

Octalsoft addressed these challenges by deploying a customized and centralized system tailored to the client’s needs. Here’s how:

Agile Development for Rapid Deployment

Using an agile development methodology, Octalsoft deployed the solution within the required timeframe. Iterative collaboration with stakeholders ensured swift approval of specifications and alignment with trial objectives.

Enhanced Collaboration Across Time Zones

Octalsoft facilitated effective virtual teamwork, enabling smooth communication across multiple time zones. This ensured stakeholders remained informed and aligned throughout the project.

Comprehensive Multi-Language Support

The ePRO solution was designed to support multiple languages, enhancing accessibility for participants worldwide. Personalized client support included multiple rounds of walk-throughs for User Acceptance Testing (UAT) of ePRO screens.

Patient-Friendly Mobile Application

Octalsoft developed an intuitive mobile application compatible with both iOS and Android devices. The user-friendly interface drove high participant engagement, resulting in:

• 80% IP (Investigational Product) compliance
• 75% real-time data completion for the trial’s primary efficacy endpoint

Seamless Hybrid Model Implementation

The hybrid model of paper and electronic diaries provided participants with flexibility, ensuring greater convenience and adherence.

Real-Time Data Integration

Advanced technology solutions, including REACT-Native, ORACLE, and RESTful APIs, enabled real-time data transfer and seamless integration between IWRS and ePRO platforms. Scheduling daily eDiary logs across various time zones with precise date/time conversions was achieved without any hitches.

Key Results

• Timely Deployment: Delivered the solution within the stipulated timeframe despite the challenges posed by the pandemic.
• High Engagement and Compliance: Achieved significant compliance and data completion rates, contributing to the trial’s success.
• Scalable and Flexible Design: Designed the solution to accommodate anticipated mid-study changes effortlessly.
• Global Accessibility: Addressed the multi-regional and multi-lingual requirements effectively, ensuring inclusivity and reliability.

Why Choose Octalsoft for ePRO Solutions?

Octalsoft’s expertise in delivering scalable, patient-centric ePRO solutions ensures the success of clinical trials even in the most demanding scenarios. Our commitment to innovation and collaboration positions us as a trusted partner for the pharmaceutical industry.

Looking Ahead

As the healthcare landscape evolves, Octalsoft remains dedicated to empowering clinical trials with cutting-edge technology solutions. Whether it’s a time-sensitive pandemic trial or a long-term study, we deliver excellence tailored to your needs.

Get in touch today to learn how Octalsoft can transform your clinical trials with our ePRO solutions!