Design and execute oncology trials faster than ever

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. 


Confidently seek approval with our global regulatory team

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.

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I am so passionate about the science. It is the entire reason I trained as an oncologist.

I was a basic researcher for some time and it is the science that really drives me every day to come to work with a happy smile. When I was in high school my best friend was diagnosed with lymphoma. It got me interested in oncology in the first place.

And then the science is what nailed the deal. And I think it's really important to listen to the patients to understand what "clinical benefit" means to them. I'm really proud that Parexel is doing this. It's involving patients more and more in all of the interactions with the clients, with the studies, with strategies to help run studies more efficiently so that the patients want to enroll and stay in studies throughout to the end.

Something that I was aware of was a study we did in breast cancer. It was a study that's going to be submitted to regulatory agencies for approval as a new therapy. And it really can shift how a breast cancer patient receives that therapy. Instead of having to take a shot, they can take a pill, which is a lot easier.

Not only did we run this study and have it submitted to the regulatory agency FDA, but we also just found out recently that it got approval.

I have every faith that all of our medics are experts in their field and can provide our clients with the best advice and the best run studies in the industry. And that's really the building block of a relationship.

Experience in the past 5 years with oncology

clinical projects
enrolled patients

Benign and malignant hematology

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.

Scott Smith, M.D., Ph.D.

Senior Vice President, Global Therapeutic Area Head - Hematology

Heidi Cho, M.D.

Therapeutic Area Head - Hematology

Ondrej Krejci

Senior Medical Director, Section Head Hematology

Katherine Minson, M.D.

Senior Medical Director

Liesel Badenhorst

Senior Clinical Operations Leader

Breast and gynecological cancers

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.”

Claudia Marques Vasconcelos

Global TA Section Head, Breast/Gynecologic Cancer

Arundhati Soman, M.D., MBA

Senior Medical Director

Pavel Jakubik, M.D.

Senior Medical Director

Shannon Archer

Senior Project Leader

Gastrointestinal cancers

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.

Gamal ElSawah, M.D.

Global TA Section Head, Gastrointestinal Cancer

Theodor Schulte, M.D.

Senior Medical Director

Dawie Kruger, M.D., MBA

Senior Medical Director

Serena Notarbartolo

Manager, Clinical Operations

Genitourinary cancers

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.

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.

Maria Cristina Villarroel

Global TA Section Head, Genitourinary Cancer

Arundhati Soman, M.D., MBA

Senior Medical Director

Lung, head, and neck cancer

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.   

Edina Tolnay, M.D., Ph.D.

Global TA Section Head, Lung/Head & Neck Cancer

Trent Klettner

Clinical Operations Leader

Phase I and rare tumors

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.

Floris Höppener, M.D.

Global TA Section Head, Phase 1 & Rare Tumors

Natalia Kochurova, M.D., Ph.D.

Senior Medical Director

Kirill Zhuravlev, M.D., Ph.D.

Senior Medical Director

Andy Gersteling

Project Leader


The specialized expertise you need

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.

More relationships, sites, and scale to accelerate study startup

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.

Driving trial design with patient insights

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.

Expertise in trial design meets best-in-class technology

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.


Therapeutic insights

See our latest insights for oncology

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