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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.

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Confidently seek approval with our global regulatory team

Our Oncology Center of Excellence includes ex-agency regulators from FDA, EMA, NMPA, MHRA, and PEI, among other bodies, as well as multiple ex-FDA regulators from CBER's Office of Tissues and Advance Therapies. 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

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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

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. 

Senior Vice President, Head, Regulatory Strategy Europe

Pengfei Song, Ph.D.

Vice President, Regulatory Strategy

Aaron Sosa, M.D.

Vice President, Technical SME Oncology, Regulatory Strategy

Bernardo Haddock Lobo Goulart, M.D.

Vice President - Technical, Regulatory Strategy

Our experts in oncology

Discover the
heart of Parexel:
our peopleLearn More

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

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. 

Senior Vice President, Head, Regulatory Strategy Europe

Pengfei Song, Ph.D.

Vice President, Regulatory Strategy

Aaron Sosa, M.D.

Vice President, Technical SME Oncology, Regulatory Strategy

Bernardo Haddock Lobo Goulart, M.D.

Vice President - Technical, Regulatory Strategy

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Experience in the past 5 years with oncology

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clinical projects
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enrolled patients
+
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 24,000+ 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.

Related insights

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De-risking Drug Development | Episode 1: How to drive value in pre-clinical development

May 28, 2024

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May 14, 2024

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Using innovative trial designs to accelerate drug oncology development

Apr 23, 2024

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The potential of neoadjuvant therapy in the treatment of solid tumors

Apr 15, 2024

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New Oncology head brings biotech industry and academic research experience

Oct 2, 2023

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Studying rare cancer patient populations using integrated genomic and real-world data

Aug 30, 2023

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A hybrid model supports globally diverse site participation for a retrospective cancer study

Jul 24, 2023

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Innovative modeling method could speed patient access to critical IO therapies

Jan 4, 2023

Related insights

CTB Podcast

Pioneering oncology trials with AVEO Oncology

Mar 11, 2025

Blog

Navigating the path to conditional approval: avoiding pitfalls in oncology drug applications

Feb 4, 2025

Blog

Navigating the Joint Clinical Assessment (JCA) implementation: An analysis of EU member states readiness, challenges and opportunities for harmonization

Jan 9, 2025

Webinar

Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)

Nov 12, 2024

Webinar

Navigating the complexities of AML drug development

Oct 30, 2024

Webinar

Highlights from ESMO 2024: How does it affect drug development going forward

Oct 11, 2024

Blog

PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers

Oct 4, 2024

Webinar

Advancing mRNA-based drug development and vaccine manufacturing

Jul 1, 2024

Podcast

Enabling Successful Sites, Episode 3: Taking the complexity out of oncology clinical trials

Jun 28, 2024

Podcast

Enabling Successful Sites, Episode 2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training

Jun 28, 2024

Blog

Patient-guided oncology trials: Why the patient perspective is essential to success

Jun 4, 2024

Blog

Making cell and gene therapy more accessible in the treatment of solid tumors

Jun 4, 2024

Podcast

De-risking Drug Development | Episode 1: How to drive value in pre-clinical development

May 28, 2024

Report

New Medicines, Novel Insights: Advancing Precision Oncology

May 14, 2024

Blog

Using innovative trial designs to accelerate drug oncology development

Apr 23, 2024

Blog

The potential of neoadjuvant therapy in the treatment of solid tumors

Apr 15, 2024

Blog

New Oncology head brings biotech industry and academic research experience

Oct 2, 2023

Blog

Studying rare cancer patient populations using integrated genomic and real-world data

Aug 30, 2023

Blog

A hybrid model supports globally diverse site participation for a retrospective cancer study

Jul 24, 2023

Blog

Innovative modeling method could speed patient access to critical IO therapies

Jan 4, 2023

Show more