Oncology and Hematology

Providing you with experience and expertise to successfully design and operationalize your trials

We provide clinical, consulting, and operational expertise, combined with years of experience in clinical research, to support clinical development in all major therapeutic classes and types of cancer. These range from molecularly targeted agents to antibody-based immunotherapies, cellular and gene therapies, antibody-drug conjugates, novel cytokines, and radiopharmaceuticals. Our experience extends across all phases of research, from Phase 0 healthy volunteer trials to Phase IV post-approval safety studies. Our consulting group includes former regulators and HTA assessors who use their first-hand experience to help design, optimize and streamline trials to more efficiently address the requirements of regulators and payers. 

Our Parexel Oncology Center of Excellence (CoE) is at the forefront of these novel therapies. We combine an Early Advisory Service of medical, regulatory, genomics and biostatistical experts with an experienced multi-disciplinary team and key technology platform partnerships. Our therapeutic area is differentiated by:

  • A dedicated group of therapeutically aligned individuals who are passionate about the science and helping patients, with academic, regulatory and industry backgrounds as well as direct clinical experience (some continuing to provide patient care), who are easy to work with and eager to collaborate to bring your drugs to market as fast as possible.
  • Extensive experience and expertise across multiple indications, drug types and trial designs, including in-depth understanding of global standards of care and the competitive landscape.  
  • Innovative approaches including adaptive designs, basket, umbrella and platform studies and model-based dose escalation trials. In addition, Parexel has extensive expertise in use of precision medicine as well as use of real-world data for generation of synthetic control arms. Our Patient Innovation Center is focused on tailored patient recruitment tactics and a patient-centric approach, including hybrid decentralized trials.
  • Investigator and site relationships, which are key to successful operationalization of oncology/hematology trials. These relationships have been fostered over several years, and many of these investigators are former colleagues functioning as KOLs in their field. 
  • We Care and With Heart Culture, which embodies everything we do. We care about the investigators that we work with, about our sponsor colleagues and most importantly, about the patients. These patients are depending on a carefully and efficiently executed study not only for personal clinical benefit, but to bring new and effective drugs to other patients in need.

 

Over the last 5 years, Parexel’s oncology and hematology experience has included:

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Specialties

Gastrointestinal Cancers

Parexel has been, and still is, at the forefront of many of the recent advances in GI cancer. Colon ...

Parexel has been, and still is, at the forefront of many of the recent advances in GI cancer. Colon Cancer and Pancreatic Cancer remain major causes of cancer morbidity, and we are actively engaged inmany 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 this endeavor.

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Lung, Head and Neck Cancer

At Parexel, we know that this condition is devastating for patients and families. We know that there is hope ...

At Parexel, we know that this condition is devastating for patients and families. We know that there is hope with new treatments and we are fully hands on and committed to bringing new treatments, cutting edge scientific advancements to patients in need.   Parexel’s 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 and 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, 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.    

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Genitourinary Cancers

Parexel’s genitourinary cancer specialists are passionate about bringing innovation to patients and supporting the ...

Parexel’s 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.

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Phase I and Rare Tumors

The Phase I and Rare Tumors team comprises varied backgrounds, including pediatric oncologists, clinical pharmacologists, and Early Phase ...

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 250 Early Phase oncology projects, of which about one-third consisted of 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.

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Breast and Gynecologic Cancers

Breast and gynecologic cancers (ovarian, uterine, and cervical cancer) have been a highly active area of clinical research at ...

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.  As a result of this commitment and research, we have seen important advances and approval of several new drugs for HER2+ breast cancer as well as triple negative breast cancer. There remains, however, a persistent need for more effective drugs, particularly for triple negative breast cancer, where we have seen the first approval of immunotherapy and a novel antibody drug conjugate. A better understanding of resistance mechanisms in hormone sensitive (HR+) breast cancer has led to approval of new targeted therapies, with several others under investigation.  Ovarian cancer represents an ongoing challenge, with a very high rate of recurrence after initial surgery and chemotherapy. Global studies of maintenance therapy following chemotherapy conducted by Parexel have significantly increased the amount of time before progression, utilizing a class of agents called “PARP Inhibitors,” taking advantage of a cancer cell’s inability to repair DNA defects, thus creating “synthetic lethality.” 

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Benign and Malignant Hematology

With over a dozen hematology-trained specialists located worldwide, the team supports clinical trials from first in human to post-registration ...

With over a dozen hematology-trained specialists located worldwide, the team supports clinical trials from first in human to post-registration studies in benign conditions and hematologic malignancies. Our group has expertise in studies involving targeting therapies, immune-oncology, cell and gene therapy, and bone marrow transplantation. Our hematologists work with clients on study design, protocol writing, safety monitoring, data review and analysis, regulatory and other strategies in drug development. Parexel hematologists deliver high-quality medical monitoring to clients from start-up biotech to large pharmaceutical enterprise. We are passionate about the recent advancements in this area and are very proud to contribute to this endeavor. 

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We are always available for a conversation.

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