For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
At Parexel, we propel your research forward by combining an early advisory service of medical, regulatory, genomics, and biostatistical experts with an experienced multidisciplinary team and key technology partnerships. We’re equipped with the experience and expertise to support you in treating all major types of cancer, across every phase of development — so your treatment gets to patients faster.
Our Oncology Center of Excellence includes more than 80 ex-agency regulators from FDA, EMA, NMPA, MHRA, and PEI, among other bodies, as well as six ex-FDA regulators from CBER’s Office of Tissues and Advance Therapies and the former Deputy Center Director of the FDA’s Oncology Center of Excellence. Our insights about highly specific regulatory processes and requirements, as well as our ongoing relationships with current regulators, help bring your breakthrough treatments to market faster.
Our experts in oncology
With over a dozen hematology-trained specialists worldwide, our team supports clinical trials from first-in-human to post-registration studies in benign conditions and hematologic malignancies. In the last five years, we’ve conducted 240+ hematology clinical projects and enrolled 35,000+ patients. We have expertise in studies that involve targeting therapies, immune-oncology, cell and gene therapy, and bone marrow transplantation.
Our hematologists work with you on study design, protocol writing, safety monitoring, data review and analysis, regulatory and other drug development strategies. We deliver high-quality medical monitoring, whether you’re a start-up biotech or a large pharmaceutical enterprise.
Breast and gynecologic cancers (ovarian, uterine, and cervical cancer) have been a highly active area of clinical research at Parexel. We know the devastating effect these diseases have on women's health and are fully engaged to fight women's cancer.
One of our focuses has been ovarian cancer, which represents an ongoing challenge in the field due to its high rate of recurrence after initial surgery and chemotherapy. Our global studies on maintenance therapy following chemotherapy have significantly increased the amount of time before progression, utilizing a class of agents called “PARP Inhibitors” that take advantage of a cancer cell’s inability to repair DNA defects, thus creating “synthetic lethality.”
We have been, and still are, at the forefront of many of the recent advances in gastrointestinal cancer. Colon cancer and pancreatic cancer remain major causes of cancer morbidity, and we are actively engaged in many trials evaluating novel and promising agents in these disease areas.
Significant advances have been seen with earlier use of immunotherapy, both as front-line therapy for advanced gastric cancer and as postoperative therapy of resected esophageal cancer. A novel antibody-drug-conjugate targeting HER2 provides new hope for patients with this subset of gastric cancers. The same therapy is under evaluation in colon cancer, and we are very proud to be part of it.
Our genitourinary cancer specialists are passionate about bringing innovation to patients and supporting the range of clinical studies from Early Phase to Phase III (registry studies), as well as expanded access use clinical studies. In the past 5 years, we have worked on 330 clinical studies among prostate, renal and urothelial cancer projects, with 30 awarded over the past two years alone as studies in this area increase.
Our team has wide experience as medical leads in different indications (adjuvant, radiochemotherapy, and in metastatic settings) and with different investigational compounds (targeted agents, checkpoint inhibitors, monoclonal antibodies, chemotherapy, and theragnostic). Our colleagues are based in Europe, North America and the APAC region, providing a global presence for high-quality medical oversight and monitoring experiences in awarded studies.
These cancers are devastating for patients and families. But there’s hope, and we are committed to bringing new treatments and cutting edge scientific advancements to patients in need.
Our lung, head and neck cancer specialists support the whole range of clinical studies from early phase to Phase III (registry studies), as well as post-approval safety trials. In the past 5 years, we have worked on nearly 100 clinical lung cancer and head and neck cancer projects, including non-small cell lung cancer, small cell lung cancer, and malignant mesothelioma trials. Our team has wide experience as medical leads in different indications (adjuvant, radiochemotherapy, and in metastatic setting) and with different investigational compounds (targeted agents, checkpoint inhibitors, monoclonal antibodies, and chemotherapy). Our colleagues are based in Europe, North America, and the APAC region, providing a global presence for high-quality medical oversight and monitoring experiences.
The Phase I and rare tumors team comprises varied backgrounds, including pediatric oncologists, clinical pharmacologists, and early phase specialists, all sharing broad oncology experience and passion for scientific innovations to support patients.
In the past 5 years, Parexel has performed more than 180+ Early Phase oncology projects, including immuno-oncology projects. Most early phase studies concerned dose escalation/expansion studies with patient populations of either solid tumors or targeted populations. Many of these studies also concerned dose escalation/expansion of an investigational medicinal product combined with an immune checkpoint inhibitor.
Our team is very experienced in both the standard rule-based escalation designs as well as the different Bayesian model–based designs and rely on the support of an experienced biostatistics group. We have ample experience with complex adaptive trial designs like two- or three-stage, basket, umbrella, and platform study designs.
Our oncology team is 1,000+ strong, including 45+ physicians with oncology experience, expertise in China and Japan, and recent key medical oncologist and ex-FDA appointments. Our clinical trial work is particularly noteworthy in the indications listed above, with experience with multiple cell and gene therapies as well.
We have access to nearly 2,500+ sites across Phase I-III solid tumors trials globally. From this number we have established strategic relationships with more than 220 solid tumor experienced sites that are part of Parexel Site Alliance network — sites that have achieved high levels of investigator satisfaction, improved number of patients recruited per site, and accelerated timelines thanks to the alignment of startup processes.
Through social listening, patient surveys, and patient burden analysis, we continually collect oncology patient insights to assess trial feasibility, improve study design, and identify risk. These practical, actionable insights help us to create more accessible trials, reduce trial amendments, increase enrollment, and improve the patient experience. These insights, when combined with our innovative recruitment and retention strategies, allow us to deliver results that exceed your expectations.
Our innovative approaches include adaptive designs; basket, umbrella, and platform studies; and model-based dose escalation trials. We also develop strong relationships with best-in-class partners pushing the boundaries of what technology can do. With innovations like artificial intelligence and machine learning, as well as streamlined data collection and reporting, we reliably deliver more efficient designs, site selection processes, recruitment strategies, and more.
Tap into our 1,000+ strong oncology team, with a wide range of experience in oncology.
Accelerate study startup with 27,000 sites across all major regions of the world, including China and Japan.
Leverage new data sources like real-world data for better results and smarter regulatory and payer decisions.
Benefit from our focus on delivery, with innovative recruitment strategies and improved data quality, collection, and reporting.
Predict drug effects ahead of time and create efficiencies with advanced modeling and simulation.
Build value from the start by gauging the drug’s commercial viability early on in development.