Speed meets strategy: Delivering a critical FDA 1572 package in just seven days

When a sponsor urgently required a completed Form FDA 1572 package within seven days to support a critical oncology Investigational New Drug (IND) submission, the stakes were high. At the time the sponsor engaged Parexel, previous delays had already compressed the timeline and threatened broader submission and funding milestones, leaving no room for setbacks.

In addition, Parexel’s Site Alliance team initially received a draft version of the protocol, adding complexity to an already compressed timeline and requiring speed, precision, and close collaboration with the selected site as key protocol details were reviewed and finalized.

Identifying the right investigator quickly

To meet the accelerated timeline, Parexel's Site Alliance team turned to one of its key differentiators: proprietary site intelligence and profiling capabilities.

Unlike traditional feasibility approaches that focus primarily on patient availability, Parexel maintains detailed profiles across its network of research sites that capture a deeper level of insight including operational readiness, investigator interests, logistical considerations, and other factors that can influence study startup performance. This deeper understanding enables the team to identify investigators who are not only scientifically qualified but also well-positioned to engage quickly and effectively.

Using these insights, the team rapidly identified a top-performing oncology investigator whose expertise, patient population, and research interests aligned with the sponsor's opportunity.

The value of trusted site relationships

Data alone was only part of the solution.

Years of relationship building with investigators and research site staff enabled the Site Alliance team to engage the selected investigator quickly and confidently. Because the team had a deep understanding of the investigator's priorities and areas of interest, conversations were focused, relevant, and productive from the outset.

This established trust proved especially valuable given the compressed timeline. Rather than navigating lengthy introductions or exploratory discussions, the team was able to move directly toward collaboration, helping keep the project on track despite the challenging circumstances.

Balancing urgency with responsible site stewardship

As pressure mounted to secure a site rapidly, the sponsor requested outreach to multiple investigators simultaneously. While broad outreach may have generated additional options, Parexel's Site Alliance team recognized the potential impact on its site network.

Engaging numerous investigators for a single opportunity can create unnecessary work for sites that ultimately will not be selected, potentially straining valuable relationships over time.

Instead, the team recommended a more strategic approach. A primary investigator was carefully selected based on alignment and readiness, while a qualified backup investigator was identified and maintained as a contingency. This approach ensured business continuity without creating unnecessary burden for the broader site community.

The strategy reflected an important principle of the Site Alliance model: strong site partnerships are built not only through engagement, but also through thoughtful stewardship of site resources and investigator time.

Delivering results under pressure

Through a combination of proprietary site intelligence, strong investigator relationships, and close cross-functional collaboration, Parexel successfully delivered the required FDA 1572 package within the sponsor's accelerated timeline.

The project progressed from initial request to site review and document delivery in a matter of days, enabling the sponsor to keep its critical IND submission on track. Following the successful execution of the project, the Site Alliance team also helped secure a remote qualification visit, further strengthening the partnership and advancing the opportunity.

A model for study startup

As clinical development timelines continue to accelerate, sponsors increasingly need partners who can do more than identify eligible investigators. Success depends on the ability to rapidly connect sponsors with the right sites, engage investigators efficiently, and execute with precision under pressure.

This project demonstrated how the combination of data-driven site selection and trusted investigator relationships can help overcome even the most compressed timelines. By leveraging deep site intelligence, strategic network management, and strong site partnerships, Parexel transformed a high-pressure challenge into a successful outcome, helping a sponsor achieve a critical development milestone when timing mattered most.
 

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