Excellence in study startup
The most reliable indicator of clinical trial success is the quality of the study startup. Even a single delay in the initial planning process can cascade through the entire journey of a new drug to market. That’s why we’ve assembled our most experienced cross-functional specialists to create the Launch Excellence team – experts who work together with a laser focus on getting everything right from the very beginning and delivering it With Heart.
Inspiring confidence in trial performance from Day One
We’ll earn your confidence that meeting milestones while accounting for headwinds that may come our way is our priority. That is the promise of our Launch Excellence team. To start up a clinical trial the following is essential: early patient engagement, meticulous attention to detail, and reliable intelligence to inform strategy.
The Parexel Launch Excellence team provides overall guidance for each study start-up, combining therapeutic knowledge with specialized skills in site feasibility, project management, process optimization, risk assessment, and much more. Our mission is to design trials for high performance with a data-driven strategy, automated workflows, and full project status visibility.
We start with knowledge derived from thousands of trials in more than 100 countries. We bridge the gaps with rich data-driven insights into performance indicators. Our methodology streamlines the project roadmap into a highly consistent and predictive forecast that minimizes risk and maximizes the chances of operational success, while planning for contingencies.
Managing end-to-end complexity
Determining the right mix of countries, sites, and patients to meet protocol requirements requires expert intelligence, combined with multiple data sources and the latest technologies to efficiently evaluatethe many factors that influence trial performance. Selecting sites and aligning resources for site activation at the right time is a mix of art and science, with the patient always our primary concern.
Activating sites as quickly as possible requires putting the pieces together in the right order, with precise hand-offs to the right people at the right times. Achieving first-patient-in milestones also involves managing end-to-end complexity and constant change. Maintaining the delicate balance between precision and flexibility in planning and execution is paramount.
Clinical trial protocols often prioritize rigorous scientific and regulatory standards at the expense of real-world scenarios, patient needs, and practical operational considerations. By synthesizing the right evidence, best practices, and patient insights to balance these objectives, we help sponsors optimize protocols with fit-for-purpose strategies. These strategies incorporate the voice of the patient while avoiding costly amendments that can wreak havoc on your budget and timelines.
Achieving realistic goals
Experience guides our ability to anticipate and overcome obstacles. Patient recruitment, for example, poses a significant hurdle for most trials and must be a top priority from the outset. Industry research shows that up to 80% of trials are delayed because of recruitment problems. Here, the human element takes precedence as we build protocols and communication programs that encourage participation by considering the patients’ physical, emotional, and practical challenges – understanding that these differ across regions and even from rural to urban populations. This dovetails with a deep understanding of country-specific standards of care and regulatory submission requirements.
Most sponsors, no matter their size, face budget constraints and skill gaps across the diverse roles required for success in study start up. The Parexel Launch Excellence team plays an essential role in partnering with our customers aim for achievable goals, given these realities – and then deliver on them.
An illustration
As one example of the effectiveness of our approach, Parexel recently worked with a pharma company whose ambitious commercial strategy mandated first-site first-dose (FSFD) within 60 days of IND clearance. Parexel not only helped the team reach that goal; FSFD was 40% faster than the sponsor had ever achieved internally.