The Importance of a Discovery Phase in Clinical Technology Implementations

An updated article that reviews how, as a technology vendor, effective preparation lays the foundation for success in GxP System Rollouts

September 19, 2024

Introduction

A key to the success of a technical system implementation is a step often referred to as a Discovery Phase. This is especially true when planning to implement a cloud-based GxP system. This structured preparatory step helps define scope, business and user requirements, configuration settings, validation strategy, and workflow processes while addressing specific challenges unique to regulated environments like pharma, biotech, and CROs. In our experience, the discovery phase is the foundation for a smooth and compliant implementation, significantly reducing the risks that typically arise later in the project.

Why It’s Important

Skipping the discovery phase is one of the most common reasons we see projects go over budget, miss deadlines, or face costly change orders. This is especially true in cloud-based, multi-tenant environments, where the complexity of GxP requirements often catches stakeholders off-guard. We’ve found that clients who have previously worked with single-tenancy or on-premise systems may underestimate the challenges of cloud implementation—particularly around validation and shared responsibilities with the vendor.

That said, securing buy-in for the discovery phase is often a challenge. Clients sometimes hesitate to invest in this step upfront, preferring to jump straight to the Statement of Work (SOW) for implementation. However, we’ve consistently seen that the discovery phase, which typically takes about 10% of the overall implementation time, helps ensure implementation completes on time and within budget by aligning the team, surfacing risks, and nailing down scope early.

Have you encountered resistance to a discovery phase in your projects? How have you made the case for it?

What is a Discovery Phase?

The discovery phase is a structured, focused period before full implementation begins. It’s designed to gather critical information about the system’s intended use, workflow requirements, and regulatory guidelines while identifying and addressing risks. However, the work is streamlined by leveraging the vendor’s extensive experience from previous implementations, allowing the project team to focus on areas specific to the current environment. Key components of the discovery phase include:

  • Targeted Research Using Vendor Expertise:
    Rather than starting from scratch, we leverage our prior experience from similar cloud-based SaaS implementations to reduce the research burden. Our knowledge of industry standards, common workflows, and regulatory requirements allows us to focus only on the key areas that matter most to this specific project. This collaborative approach between the vendor and client ensures that the discovery phase highlights critical differences and customizations needed for the client’s unique environment, minimizing unnecessary work while ensuring all regulatory needs are met.
  • Workflow Assessment and Mapping:
    Many clients lack up-to-date documentation of their workflows, making it difficult to understand how existing processes will evolve. During discovery, we work with the client’s team to map out workflows, using our knowledge from similar projects to expedite this process. This creates a foundational understanding of how the system will impact operations and establishes a clear baseline for Performance Qualification (PQ) and post-go-live tracking of operational metrics.
  • Validation Strategy Alignment:
    One of the most significant risks in GxP environments is system validation, and multi-tenant, cloud-based systems introduce additional complexity. The vendor typically manages Installation Qualification (IQ) and Operational Qualification (OQ), while the client focuses on PQ or User Acceptance Testing (UAT). With our extensive validation experience, we streamline this alignment process, ensuring all stakeholders are clear on their roles and responsibilities early in the project. This is key to preventing costly delays later in the implementation.

What have you found to be the most challenging aspects of integrating vendor expertise with your specific needs in cloud-based implementations?

Key Deliverables of the Discovery Phase

The discovery phase yields several crucial deliverables that set the foundation for a successful implementation:

  1. A Comprehensive Statement of Work (SOW)
    A well-defined project scope is essential in multi-tenant systems where customization options may be limited. A solid SOW minimizes scope creep and establishes clear expectations between all parties involved.
  2. A Reliable Project Schedule
    Creating a project roadmap with milestones and timelines helps manage expectations and keeps the project moving smoothly. With cloud-based implementations, the coordination between internal teams, vendors, and third-party consultants adds complexity—this roadmap ensures everyone is on the same page.
  3. A Justifiable and Realistic Budget
    Projects that skip the discovery phase often see significant budget overruns due to unforeseen challenges. By dedicating approximately 10% of the project timeline to discovery, we can provide a more accurate budget and significantly reduce the risk of costly change orders later.

Have you seen projects go over budget because discovery was skipped or not thorough enough? How do you ensure budgeting stays realistic?

  1. Risk Management Plan and Communication Protocols
    Identifying risks early in the project is crucial to avoiding delays. For cloud-based SaaS systems, it’s vital to establish clear communication channels between all parties—client, vendor, and external partners—to ensure validation, security, and compliance expectations are met.
  2. Initial Stakeholder Engagement and Alignment
    Successful projects require the early alignment of all stakeholders. In multi-tenant environments, roles and responsibilities are often distributed across the client and vendor teams, making clear expectations crucial from the outset.

Challenges and High-Risk Areas

Despite the clear benefits, the discovery phase is often a tough sell, especially when clients are reluctant to pay for it upfront. However, we’ve found that projects without a discovery phase are far more likely to run into trouble later, whether through misaligned validation expectations or poorly understood integration points with existing systems.

Another high-risk area is coordinating multi-disciplinary teams. Cloud-based GxP implementations require active participation from the client, vendor, and, often, third-party consultants. Discovery provides a “warm-up period” for teams to align and gain trust. Without developing this early engagement across all teams, a lack of coordination and communication can cause significant delays.

Have you faced challenges getting stakeholders to engage early in a project? How did you manage coordination between multiple teams during implementation?

Justifying the Discovery Phase

While some clients may hesitate to invest in a discovery phase, what we’ve seen time and again is that the cost of this phase is far outweighed by the risks it mitigates. Projects that skip discovery are far more prone to cost overruns, missed deadlines, and post-rollout patches—issues that often arise from poor planning and unclear scope.

By dedicating the equivalent of 10% of the overall implementation timeline to discovery, the project is more likely to stay on time, on budget, and aligned with GxP requirements.

Have you noticed how much easier projects are to manage when discovery is thorough? What success stories have you experienced with discovery in your own projects?

Mitigating Implementation Project Risk During Discovery

One of the major benefits of the discovery phase is that it mitigates risks by drawing on the vendor’s previous experience while also tailoring solutions to the client’s specific needs. Our past implementations give us a comprehensive understanding of common risks, enabling us to focus on the unique challenges of the current project.

  • System Validation Strategy:
    Leveraging our deep experience in GxP environments, we work with the client to align validation strategies quickly and efficiently. Since we’ve seen the common validation hurdles in similar projects, we can anticipate and avoid issues that might otherwise delay the project. This ensures that both vendor and client teams are clear on their respective responsibilities, especially for IQ, OQ, and PQ, from the very beginning.

  • Data Migration and System Integration:
    Data migration and system integration are significant risk areas that require careful planning. We use our expertise from previous migrations to design a streamlined approach, ensuring that the specific challenges of this project are addressed without duplicating effort. By focusing on key data and integration points that matter most to this client, we can reduce the risk of migration-related delays.

  • Configuration Specification Evaluation:
    Misconfiguration can lead to delays and failed validation. With our extensive background, we know where common configuration issues arise and address them proactively. This experience allows us to focus on the specific configurations that are crucial for the client’s unique needs, ensuring that validation will proceed smoothly.

  • Stakeholder Engagement for Validation Alignment:
    With past experience guiding us, we facilitate early and meaningful stakeholder engagement. Our familiarity with multi-tenant environments allows us to focus on aligning validation requirements efficiently, ensuring that all stakeholders—from the client’s regulatory teams to third-party consultants—are fully integrated into the project’s success from the outset.

Conclusion

The discovery phase is a critical preparatory step in any cloud-based SaaS, multi-tenant GxP system implementation. By leveraging the vendor’s experience and focusing on the client’s specific needs for the system, this phase ensures a streamlined process that reduces risks and keeps the project on time and within budget.

At Driftpin, we know how to run an effective discovery phase that delivers key results like a comprehensive Statement of Work (SOW), realistic project schedules, and a solid risk management plan. Our expertise ensures the creation of operational baselines, definition of KPIs, and setting of post-go-live success metrics, giving your project a clear roadmap for long-term success.

Most importantly, we help mitigate high-risk areas—such as system validation, data migration, and integration—by aligning stakeholders early and focusing on what matters most for your project.

In short, Driftpin’s proven discovery process sets the foundation for a successful implementation, ensuring compliance, budget, and timeline goals are met. Let us help you make your next project a success.

Have you seen the benefits of thorough discovery in your projects? What challenges or successes have you experienced? We’d love to hear your thoughts.