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Oncology CRO

Design and execute oncology clinical trials faster than ever

At Parexel, we propel your research forward with a full range of oncology CRO services, 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.

Read the transcript

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.

Our experts in oncology

Amy McKee, M.D.

Chief Medical Officer & Global Head, Oncology Center of Excellence

Gwyn Bebb, M.D., BM, BCh, Ph.D.

Senior Vice President, Global Therapeutic Area Head – Oncology

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

Senior Vice President, Global Therapeutic Area Head - Hematology

Allen Zhong, M.D., Ph.D.（钟飞）

Vice President, Oncology Therapeutic Area Head APAC

Claudia Marques Vasconcelos

Global TA Section Head, Breast/Gynecologic Cancer

Floris Höppener, M.D.

Global TA Section Head, Phase 1 & Rare Tumors

Gamal ElSawah, M.D.

Global TA Section Head, Gastrointestinal Cancer

Maria Cristina Villarroel

Global TA Section Head, Genitourinary Cancer

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

Global TA Section Head, Lung/Head & Neck Cancer

Sinan Sarac, M.D., Ph.D., M.Sc. 

Vice President, Technical - Regulatory Strategy

Pengfei Song, Ph.D.

Vice President, Regulatory Strategy

Experience in the past 5 years with oncology

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clinical projects
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enrolled patients
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sites
Indications

Benign and malignant hematology

Our team of specialists provides comprehensive support for clinical trials in both benign conditions and hematologic malignancies, covering all stages from first-in-human to post-registration studies.

Our expertise extends to areas such as targeted therapies, immune-oncology, cell and gene therapy, and bone marrow transplantation.

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Breast and gynecological cancers

Breast and gynecologic cancers are active areas of clinical research at Parexel. We understand the significant impact these diseases have on women's health and are deeply committed to combating women's cancer.

Our global studies have made significant advancements in maintenance therapy following chemotherapy, increasing the duration of remission.

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Gastrointestinal cancers

We are actively involved in numerous trials for evaluating new and promising agents in colon cancer and pancreatic cancer, which continue to be significant contributors to cancer morbidity.

We have witnessed notable progress in the use of immunotherapy, particularly in front-line therapy for advanced gastric cancer and postoperative therapy for resected esophageal cancer.

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Genitourinary cancers

Our dedicated genitourinary cancer specialists are committed to introducing innovative treatments to patients and facilitating a wide range of clinical studies.

With extensive expertise in various indications and with diverse investigational compounds, our experienced team, located in Europe, North America, and the APAC region, ensures global accessibility and delivers exceptional medical oversight and monitoring for awarded studies.

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Lung and head-and-neck cancer

Our dedicated team of lung and head and neck cancer specialists conducts a comprehensive range of clinical studies, including early phase to Phase III trials and post-approval safety trials.

With our experienced team and global presence, we strive to bring hope and innovative treatments to patients in need.

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Phase I and rare tumors

Our Phase I and rare tumors team is a diverse group of experts with backgrounds in pediatric oncology, clinical pharmacology, and early phase research.

We're experienced in both standard rule-based escalation designs and Bayesian model-based designs and excel in complex adaptive trial designs.

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Advantages

The specialized expertise you need

Our oncology CRO 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.

An oncology CRO (Clinical Research Organization) is a specialized organization that provides support and services for conducting clinical trials in the field of oncology, which focuses on the diagnosis and treatment of cancer.

Oncology CROs assist pharmaceutical and biotechnology companies, as well as academic institutions, in various aspects of clinical research, including study design, regulatory compliance, site selection, patient recruitment, data management, monitoring, and analysis. They work closely with investigators, healthcare professionals, and patients to ensure that clinical trials are conducted in a safe, efficient, and ethical manner.

The main goal of an oncology CRO is to accelerate the development of new cancer treatments and therapies by effectively managing clinical trials. By leveraging their expertise in oncology research, these organizations help to advance scientific knowledge, improve patient outcomes, and contribute to the fight against cancer.
 

Precision oncology, also known as personalized or targeted oncology, is an approach to cancer treatment that involves tailoring therapy based on an individual's specific genetic, molecular, and clinical characteristics. It aims to identify the unique characteristics of a patient's tumor and choose the most appropriate treatment strategy to maximize effectiveness and minimize side effects.

Precision oncology relies on advances in genomic sequencing technologies and molecular profiling to identify specific mutations or alterations in a patient's tumor that drive cancer growth. These identified genetic or molecular abnormalities can be targeted with specific drugs or therapies that are designed to inhibit or exploit those particular alterations within the cancer cells.

It is important to note that while precision oncology has transformed the treatment landscape for some cancers, it is still an evolving field with ongoing research and clinical trials aimed at identifying new targets and improving patient outcomes.
 

Highlights

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.

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