BiTE led the entire process – from initial SME interviews, internal research and design through native iOS and Android development, Salesforce integration, and deployment – of a purpose-built app for clinical research assistants (CRAs). The result? A cost savings of $8.5M / year.

Building a Better CRA for ICON

Background

We’ve done quite a few projects for ICON, but none as critical as this one. To understand why, let’s talk a little bit about the role of a Clinical Research Associate (CRA).

Before a drug can be prescribed and sold, it has to be proven safe and effective. But getting to that point requires years — often decades of complex, intensely regimented testing, all overseen by the FDA. If a testing site goes out of compliance, the schedule can slip, and millions of dollars can be lost (not to mention the future of the drug itself).

Enter the Clinical Research Associate. CRAs monitor the testing process, ensuring clinics stay in compliance and trials stay on track. They mitigate risk and are critical to the success of any clinical trial.

“BiTE’s senior leadership helped us embrace BDD, define the core strategy and provide critical architecture for our next generation clinical trial platform.”

Jesse O’Gorman
Vice President

Symptoms

When ICON first approached us with this project, they wanted an app that would help CRAs log their travel time and receipts. But at BiTE, we specialize in finding the source of friction and solving real problems for our clients.

We met with dozens of Clinical Research Associates and Clinical Team Managers in the U.S., Europe, and Russia and conducted Jobs-to-be-Done interviews. We asked them what made their jobs difficult and what differentiated a “good” CRA from a “bad” CRA. We studied the processes and protocols of CRAs around the world and read over 30 Standard Operating Procedures (totaling more than 700 pages). All in search of hidden problems we could solve so that CRAs could do their jobs better.

We dove deep.

Treatment

We realized the problem wasn’t just that CRAs needed an easier way to log their hours and track receipts. The real job to be done was building a better Clinical Research Associate. ICON was hiring this product to achieve a competitive advantage by lowering the operating costs of CRAs and speeding drug trials by keeping more sites in compliance.

One of the key goals of our proposed solution was to keep sites in compliance, while bringing those out of compliance back into compliance more quickly, with less risk and at less cost. And each feature we proposed helped reduce waste, allowing associates to work even when out in the field, assign follow-up tasks, securely manage documents, and log communications.

ICON was on board.

If this seems like a lot of preamble before we talk about the product we built, that’s the point. Because developing the right strategy that identifies the jobs CRAs need done and the features required to do them is key to making the products. All before a single line of code is written.

Follow-Up

Using the Jobs-to-be-Done methodology, we learned what really makes a Clinical Research Associate successful and identified obstacles that can limit that success, eat up precious time, and cost money. Every feature we developed in the mobile iOS and Android apps solved real problems for our client.

And speaking of cost, we did a separate study to evaluate the efficacy of our strategy — in hours spent filing papers, logging calls, and creating follow-up instructions, our app is estimated to save ICON $8.5 million per year.

The final product was not what ICON had originally envisioned — it was more. Our solution was exactly what our client needed and wanted. After all, that’s the point of good strategy — to guide you to the best outcome possible.

Enhancing Product Strategy and Development Efficiency for ICON through Agile and BDD Implementation

BiTE Interactive was engaged by ICON to serve as executive advisors to both their business and technical leadership. ICON sought our expertise in Product Strategy, adding us to their governing product review board, as well as our technical expertise, with direct reporting to their executive in charge of technology. The goal was to streamline their existing development process and guide the design for the development of the next generation of their existing clinical trial platform.

Objectives

Streamline ICON's existing development process.
Guide the design for the next-generation platform.
Train the entire staff on Agile methodologies built around Behavior Driven Development (BDD).
Lead the team in Example Mapping and writing BDD requirements.
Design the systems and architecture for the next-generation platform.
Manage the offshore team in building out the platform.
Coach on effective testing strategies and application of BDD.

“BiTE’s senior leadership helped us embrace BDD, define the core strategy and provide critical architecture for our next generation clinical trial platform.”

Jesse O’Gorman
Vice President

Approach

1. Streamlining the Development Process

BiTE began by conducting a thorough analysis of ICON’s current development process. This involved:

Detailed process mapping to identify inefficiencies and bottlenecks.
Engaging with stakeholders through interviews and workshops to understand pain points and areas needing improvement.
Proposing and implementing a streamlined development workflow tailored to ICON’s specific needs.

2. Training on Agile and Behavior-Driven Development (BDD)

To ensure a robust foundation
for future development, we conducted comprehensive training for the entire ICON staff on Agile methodologies centered around BDD. This included:

Conducting several days of workshops that covered Agile principles and BDD concepts.
Teaching through a mix of group sessions, breakouts, and individual coaching to cater to different learning styles.
Providing hands-on training in Example Mapping and writing BDD requirements to ensure practical understanding and application.

3. Writing Requirements for the Next-Generation Platform

Our team led ICON’s SMEs in:

Example Mapping sessions to collaboratively define requirements.
Writing detailed BDD requirements that clearly articulated user stories and acceptance criteria.
Ensuring all requirements were aligned with the strategic vision for the next-generation platform.

4. Systems and Architecture Design

As ICON moved into the platform development phase, BiTE’s architects:

Designed the systems and architecture to support the new platform.
Ensured the architecture was scalable, robust, and aligned with ICON’s business goals and technical requirements.

5. Managing the Offshore Development Team

BiTE Interactive took on a direct management role for ICON’s offshore development team, focusing on:

Overseeing the day-to-day development activities to ensure alignment with project goals.
Coaching the team on effective testing strategies and the application of BDD to maintain high-quality standards.
Facilitating continuous communication and collaboration between the onshore and offshore teams to mitigate risks and ensure timely delivery.

Results

Enhanced Development Efficiency: Streamlined processes led to faster development cycles and reduced bottlenecks.
Empowered Staff: Training on Agile and BDD equipped the staff with modern development methodologies, improving overall productivity and collaboration.
High-Quality Requirements: Well-defined BDD requirements ensured clarity and alignment on project goals, reducing rework and enhancing quality.
Robust Architecture: The new platform’s systems and architecture were designed to be scalable and resilient, supporting future growth.
Effective Team Management: Direct management and coaching of the offshore team resulted in improved testing strategies and successful platform development.

Ensuring Success in a Global Clinical Trial Amidst a Pandemic

Background

Faced with tight timelines, a complex protocol with frequent protocol updates, and the need to maintain regulatory compliance across the US, Europe, and South America, ICON asked BITE to rescue its COVID trail projects in the middle of a global pandemic.

Objectives

Ensure an on-time launch despite tight deadlines and numerous challenges.
Stabilize the existing decentralized clinical trial (DCT) platform.
Navigate regulatory requirements across multiple countries.
Swiftly adapt to changing study protocols.
Provide robust support for multiple languages and global sites.
Resolve integration failures, infrastructure instability, and data loss issues.
Ensure regulatory compliance during audits.
Digitize and manage informed consent forms (ICF) across multiple countries.

“BiTE’s strategic and technical guidance has been instrumental in transforming our development process and setting up our next-generation platform for success. Their strategy, architecture, and BDD expertise has significantly improved our workflow and team capabilities.”

Jesse O’Gorman
Vice President

Approach

Consent at Scale

BiTE supported the digitization and management of informed consent forms (ICF), ensuring compliance and streamlining the consent process. This included:

Digitizing more than 10,000 ICF forms to streamline data collection and ensure accuracy.
Supporting clinical teams in managing consent processes across multiple countries.

Regulatory Compliance

Navigating regulatory requirements across multiple countries was a significant challenge. BiTE successfully:

Supported the creation of ICF documents in over nine countries, ensuring compliance with local regulations and ethical standards.
Participated in the European Medicines Agency (EMA) audit, compiling comprehensive data reports to ensure regulatory compliance.

Platform Stability

BiTE intervened to stabilize ICON’s existing DCT platform. This included:

Releasing multiple hotfixes to address environmental scaling issues that caused application outages and data loss.
Collaborating with EDC and IRT vendors to resolve integration issues.
Performing planned releases and hotfixes throughout the six-month study to address bugs threatening data integrity and compliance.

Protocol Changes Without Delays

The urgent nature of the pandemic meant that study protocols were frequently updated. BiTE swiftly translated approved protocols into working software to ensure the study could proceed without delay.

Global Support

BiTE provided support for nine different languages and 15 sites across the US, Europe, and South America.

Conclusion

By swiftly adapting to changing protocols, supporting multi-country consent processes, and stabilizing an existing platform, BiTE ensured the studies’ successes and contributed significantly to the global fight against COVID-19.