Four-Steps to Accelerate Study Start-up Cycles


Identifying KPIs, benchmarks, key data points, and an actionable plan are all keys to accelerating study start-up cycles.

Anusha Shetty, director, strategy, site startup, and engagement at Veeva

Anusha Shetty, director, strategy, site startup, and engagement at Veeva

Completing study start-up in clinical trials takes determination, coordination, and continuous process improvement. The average time from site identification to study start-up completion is nearly eight months.1 This reflects challenges as teams continue to work in silos, follow complex workflows, and manage international regulations.

A top 20 biopharma found that applying a four-step methodology supported by advanced clinical applications for early trial processes could decrease selection to site activation time by 30% and start-up packet sent to activation time by 36%.

For other companies trying to achieve faster study start-ups, valuable lessons can be learned from their use case, including the importance of measuring key performance indicators (KPIs), ensuring easy access to data, and establishing a sustainable data-driven model.

Source: Veeva

Source: Veeva

1. Identifying companywide KPIs

Establishing KPIs and metrics is the first step in understanding how to streamline existing trial processes. The biopharma used historical data to identify and define what a high-performing study start-up looks like, then kicked off an organization-wide effort to measure cycle times and provide insights.

In addition to gathering KPIs from their top-performing studies, they identified a list of sub-KPIs that track towards achieving the larger study start-up metrics. For example, site IRB submission to approval and first site activated to 80% sites activated. This helped drill into specific areas of improvement.

2. Establishing company and industry benchmarks

The next step is establishing baseline performance. Gathering and cleaning existing data—including what is involved in every step, the time it takes, and the people and departments involved—is a complex task even for savvy, data-driven companies.

Using historical and industry data to establish benchmarks can highlight critical areas needing improvement, investment, and efficiency gains. For example, evaluating handoffs can determine if there are delays when tasks transition to a different team or role and could lead to reductions in cost, effort, or study timelines.

3. Analyzing data and deriving actionable insights

The next critical step is the ability to quickly generate and drill down into reports to drive action. Establishing these reports enables the study start-up leadership team to review every tracked data point and gauge progress or identify issues early on. Using modern clinical tools, the top 20 biopharma’s study start-up team created KPI-specific dashboards, offering transparency across functions and roles.

Study start-up teams must have the right level of visibility to help drive the performance improvement initiative. Data and reports can help with that. Dashboards provide visibility into how teams perform against peers within a study or across therapeutic areas, while filters enable an organization to analyze information by study, country, and site. The key is for each dashboard to tell the whole story of the start-up process and highlight milestones.

4. Putting a plan in place and validating the framework

As the final piece to the four-step model, assign a person or department to measure processes, track progress, and monitor governance. With clear owners and a path forward, prioritize performance within specific countries.

A global approach ensures clinical teams can identify challenges or bottlenecks and develop mitigation strategies. By looking at country-level KPIs, organizations can also identify specific regional enhancements and improve start-up cycle times.

Achieving faster, more efficient trial starts

Modern study start-up technology is critical to applying the four-step methodology so companies can improve selection to site activation time and start-up packet sent to activation time by nearly one-third. An advanced tool can also enhance how sponsors and research sites work together, driving faster time to value.

Collaboration and communication with sites are critical parts of study start-up. Many sites manage requests for information and documents via email or multiple sponsor products with different logins. A unified, end-to-end study start-up application that covers all parts of the process globally and across stakeholders (sponsors, CROs, and sites) can help alleviate these pain points. Other benefits of a unified study start-up solution include:

  • Database of global personnel and site information for greater visibility
  • End-to-end workflows, alerts, milestone, and document tracking for faster execution
  • Process automation to free up time for value-add activities
  • Reports and dashboards for data-driven decision-making
  • The option to automate site document and information exchange, providing a simple, consistent way to engage with sites

An advanced study start-up application can significantly improve clinical operations by planning and tracking milestones and expected document lists. Managing study, country, and site-level milestones with expected documents provides greater visibility into the study’s critical path, eTMF completeness, and KPIs across studies.

These steps enable organizations to garner greater insights and mitigate risks while encouraging collaboration. The goal of reducing study start-up cycle times is well within reach for those embarking on a journey to modernize early trial processes.

Anusha Shetty, director, strategy, site startup, and engagement at Veeva


  1. STAT News, Clinical trials take a long time to get started. Here's how to speed it up, 2018
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