The Challenge: Navigating a Complex Selection Process

For a leading global pharmaceutical company, selecting the right platform for managing regulatory registrations and publishing was critical. With their existing submission document management and submission archiving systems remaining in place, the organization needed to identify the best solution to complement these systems while enhancing their overall regulatory operations.

The challenge wasn’t just finding a platform with the right capabilities; it was about ensuring a methodical, data-driven selection process that accounted for technical requirements and user experience. The company required a structured approach to define and evaluate requirements, manage vendor demonstrations, and present a well-supported recommendation to senior leadership.

The SelectAssist Approach: A Structured and Data-Driven Process

Enter fme’s SelectAssist, a proven methodology designed to help life sciences organizations navigate the complexities of software selection. Our approach ensured the client’s selection process was systematic, comprehensive, and aligned with their business objectives.

1. Requirements Definition & Prioritization

Working closely with stakeholders, fme facilitated the creation of a detailed set of functional, technical, and business requirements. Using qualitative and quantitative measures, we ensured that every need was captured, prioritized, and weighted based on importance. The process included:

• Gathering input from business, IT, and regulatory stakeholders
• Structuring requirements into a detailed matrix with over 2,500 unique requirements
• Establishing scoring criteria for vendor evaluation

2. Vendor Evaluation & Demonstration Management

With a strong foundation of requirements, we supported the client’s procurement team as they engaged vendors and managed the selection process. Our role included:

• Assisting in defining the Request for Information (RFI) process and ensuring alignment with business needs
• Providing guidance on vendor selection criteria and helping the client narrow down the initial list of six vendors
• Designing scripted demo sessions that required vendors to showcase real-world use cases rather than generic presentations

Using scripted demos, we ensured that vendors demonstrated how their platforms would handle specific regulatory workflows, giving stakeholders a true sense of usability and fit.

3. Conference Room Pilot & User Feedback Analysis

To further validate vendor capabilities, fme facilitated Conference Room Pilot (CRP) sessions, allowing key users to test the solutions in real-world scenarios. During this phase, we:

• Designed hands-on evaluation scenarios aligned with actual regulatory workflows
• Collected user feedback through structured surveys, gathering over 50 individual evaluations from key stakeholders
• Combined user sentiment with objective performance data to create a well-rounded assessment

By structuring feedback collection, we quantified user impressions and balanced them with objective performance metrics, ensuring that the selection was based on a blend of user experience and functional fit.

4. Final Selection & Executive Presentation

With all data collected, our team compiled the findings into a comprehensive evaluation report. This included:

• A side-by-side vendor comparison based on weighted criteria
• A risk assessment for each potential solution
• A recommendation backed by both quantitative data (scoring, performance metrics) and qualitative insights (user sentiment, stakeholder interviews)

The final step was delivering an executive presentation that distilled complex selection criteria into a clear and compelling case for senior leadership. Our structured reporting helped secure executive buy-in, ensuring a confident and well-supported decision.

The Results: Confidence in the Right Choice

Through SelectAssist, this leading global pharmaceutical company was able to move forward with confidence, knowing that the selected platform was technically sound, user-validated, and strategically aligned with their long-term regulatory goals.

By leveraging a combination of quantitative scoring, structured vendor demos, and user-driven evaluations, the company not only minimized the risk of selecting the wrong solution but also maximized the chances of successful implementation and adoption.

Why SelectAssist?

fme’s SelectAssist methodology offers life sciences companies a structured, transparent, and data-backed approach to software selection. Whether evaluating Regulatory Information Management (RIM), Publishing, Quality, or Clinical systems, our approach ensures:

• Comprehensive requirements definition – Aligning software selection with strategic business needs
• Seamless integration consideration – Ensuring the new platform fits within existing infrastructure
• Stakeholder engagement & adoption – Prioritizing end-user needs for long-term success
• Balanced decision support – Combining technical, financial, and usability assessments
• Future-proof solutions – Selecting platforms that can adapt to regulatory changes and business growth

Are you facing a similar challenge in selecting the right software for your regulatory or quality operations? Download our SelectAssist datasheet below and contact fme today to learn how SelectAssist can provide the clarity and confidence you need to make the right choice.