Bring speed, experience, and insight to your trials with a proven Phase I oncology CRO
Our Phase I oncology team is made of clinical pharmacologists, first-in-human specialists, strategic statisticians, medical doctors, and more — all unified by extensive oncology experience and a commitment to helping you change patient lives. We have deep expertise in dose escalation/expansion studies, which includes experience with:
- Patient populations with a broad range of solid tumors
- Pre-specified targeted patient populations
- A wide range of investigational products like chemotherapy, targeted treatments, immunotherapy, antibody-drug conjugates, radiopharmaceuticals, cancer vaccines, T-Cell engagers and cell and gene therapy
- The combination of investigational products with other agents, such as an immune checkpoint inhibitors
All possible rule-based, model based or model assisted dose escalation designs including accelerated titration.
As a proven Phase I oncology CRO, we’re also leaders in complex adaptive trial designs (such as two- or three-stage, basket, umbrella, and platform studies) and have developed best practices in the evolving use of flexible study design in oncology research.
Experience in the past 5 years in Phase I oncology
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clinical projects
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patients
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sites
Advantages
Accelerated timelines
At Parexel, we’re always looking ahead, with our regulatory experts charting the clearest course to approval. We streamline site selection through our Parexel Site Alliance Network, which includes 300+ sites around the world, and we expedite start-up with committed specialists who are knowledgeable about the start-up requirements in different countries.
Advanced patient recruitment & retention
Finding the right patients isn’t easy. But as a well-established oncology CRO, we use AI-driven feasibility models, real-world data, and strong site relationships to hone in on the right countries and sites for your study — successfully recruiting patients even in competitive environments. We also know how to keep patients and sites engaged throughout the study, to keep your trial on track.
Specialized Phase I team
From the start, you get access to a small, agile team of our Phase I specialists. They integrate closely into your team and adapt quickly to the challenges and opportunities that arise. All team members will be experienced in Phase I dose escalation studies and will know how to optimize and speed up the dose escalation phase with a quick turn-around of essential safety data; intensive site contact; swift planning and performance of safety and SRC meetings.
They’re also supported by our larger group of medical and scientific specialists, who offer expertise in new and emerging treatments, such as checkpoint inhibitors, tumor vaccines, t-cell engaging antibodies, and others.
Global regulatory experience
Our team of 1,000+ global regulatory experts, including former regulators from the FDA, EMA, and other agencies, help you navigate regulatory and market access hurdles. As your Phase I oncology CRO, we provide 360-degree insights to position your study for a fast approval and transition to Phase II.