Phase IIB-IV Clinical Trials

Produce the right data with a risk-based approach to innovative clinical trial design

To best serve patients and clinical trial sponsors, we take a risk-focused approach to innovative clinical trial design, planning, and execution. Throughout each of these stages, our team continually assesses risk to control it and adapt as we move forward. Evaluation begins with risks to critical data and processes, as well as country selection, site-specific variables, and data integrity.

This upfront risk evaluation informs the entire study plan. We bring clinical expertise to portfolio- and study-level planning — harnessing the power of data-driven insights, historical knowledge, database intelligence, and thorough scenario planning.

A balanced study design

A well-designed protocol accounts for patient safety, data integrity, and operational feasibility. Our team of medical, biostatistical, and operational experts help you balance these sometimes-competing priorities.

Today, the distinction between trial phases has blurred, with more flexibility in trial design — often combining multiple studies in a single, overlapping protocol. Flexible, adaptive designs allow for accelerated development through the ability to rapidly declare one or more treatments superior, drop treatments for futility, or dynamically add new treatments to be tested. However, adaptive approaches require expert biostatistical oversight, and close collaboration between clinical operations, data management, medical experts, and project leadership for design, planning and execution. As decentralized trial designs increase in adoption, we look at the needs and requirements of your trials to see how patients may benefit from DCT components.

During protocol development, our patient engagement team makes recommendations for minimizing patient burden by reviewing the frequency and duration of treatments, invasiveness of procedures, and any participation requirements that are likely to pose compliance challenges, among other factors.

Trial execution around the world

Our global reach for adaptive trials extends across the Americas, Europe and Asia. We cover the whole globe and are one of the CROs in Asia, with a presence in Japan, China, Korea, and India. From designing and running pivotal trials, to navigating regulatory hurdles, we’re ready to meet your needs anywhere with attention and efficiency, providing:

• A focused team handling all study start-up activities
• Advanced resource planning tools that dynamically match resource needs at every stage based on a range of variables
• Multidisciplinary project management to centralize efforts and ensure transparency and collaboration
• Data stream integration, with efficient workflows to ensure regulatory-grade data at every handoff
• Medical writing expertise to handle applications and other key documents

Industry leaders in patient inclusion

Global regulators are requiring trial populations to include participants from underrepresented racial and ethnic populations. At Parexel, patient inclusion is a priority in considerations of race, gender, age, ability, economic status, and more. We have the experience and proven strategies to make your trials more inclusive.

The path to commercialization

As your product transitions from development to commercialization, our late-phase experts provide dedicated project management, with global resources to customize solutions for local markets.

We have the regulatory expertise to manage the final lap of the journey — filing the new drug application (NDA) or market authorization submissions. This highly specialized expertise relieves your team of this complicated and time-consuming responsibility.

Our specialists tailor scientific, strategic, and market solutions to meet your business goals. We help you develop a market access strategy that will build value quickly, while closely monitoring long-term effects and safety.