In a complex and constantly evolving cancer research environment, you expect your CRO partner to have a clear understanding of the latest regulatory challenges and a firm grasp on the most innovative and cutting-edge technologies in oncology research. We do.
But we don’t just offer those things — our approach is unique. We seek to understand your needs and to build a collaborative relationship so we can deliver on your goals in the most effective and efficient way possible.
- What are your key business drivers and corporate commitments?
- Which cancer indications are you targeting, and in which order are they prioritized?
- What are your current and forward-looking internal resources?
- What processes have you already established?
Your answers to these questions help us tailor our resources and technologies to provide exactly the right solution for your circumstance — driving decisions and operational excellence from your program’s start through its finish.
Our ultimate goal is to help enhance and improve health around the world, and we are proud to play a part in your quest to develop new cancer therapies.
True understanding of cancer research comes directly from experience, and only understanding and experience can ensure your study’s success. You can count on Chiltern’s knowledge to carry you through a successful trial. Our team’s professional and therapeutic experience is diverse.
Individual Oncology Experience
Chiltern’s oncology expertise runs deep:
- Most team members have backgrounds as physicians, nurses or pharmacists
- Experienced management team have an average of 10 years in oncology development
- More than 90 percent of oncology CRAs have monitored at least three cancer protocols to study completion in their careers
Team Oncology Experience
Chiltern’s oncology expertise runs deep with teams that:
- Include senior medical directors who are board-certified in medical oncology and hematology
- Have conducted hundreds of oncology trials
- Are differentiated between early-phase work and registrational clinical and late-phase development
Our internal Scientific Advisory Board is composed of leading global oncologists and thought leaders, positioning us to support clinical, statistical and regulatory aspects of a wide range of adaptive design studies.
Choose Chiltern’s specialized oncology teams for deep experience and understanding in trials for:
- Cancer vaccine therapy
- Gene-targeted therapy
- Rare-disease compounds
- Virus vector
Over the last five years, we have conducted more than 500 oncology trials.
Oncology – Bio and Med Device
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Solid Tumor Experience
- Bladder cancer
- Brain cancer
- Breast cancer
- Colorectal cancer
- Esophageal cancer
- Gastric cancer
- Head and neck malignancies
- Hepatocellular carcinoma (HCC)
- Liver cancer
- Lung cancer
- Malignant melanoma
- Non-small cell lung cancer (NSCLC)
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Renal cancer
Chiltern is aware of the requirements of hematological oncology studies and the benefits of specific experience in this area. With access to board-certified hematologists, oncologists and other specialists as well as investigator sites experienced in diseases and conditions of the blood, Chiltern will deliver the expertise you need for your next hematology trial.
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic lymphocytic leukemia (CLL)
- Chronic myelogenous leukemia (CML)
- Hodgkin lymphoma
- Multiple myeloma
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin lymphoma
- Peripheral T-cell lymphoma
- Polycythemia vera
- Rare oncology diseases
Oncology Medical Device & Diagnostics Experience
Chiltern has conducted a wide variety of feasibility, pivotal and observational medical device, diagnostics and drug-device combination studies in oncology. Our device experience has included investigative sites in every geographic region of the world, including North America, Europe, Middle East, Africa, Latin America and Asia-Pacific. We have significant expertise in complying with country-specific ethics and regulatory requirements for specialized oncology devices (e.g., radioactive) to ensure timely approvals.
Through broad experience, Chiltern offers the skills and knowledge to start complex oncology trials quickly and proficiently. We have specific expertise in supporting adaptive design trials and the transition from feasibility to later phase clinical development. Our capabilities and global footprint will accelerate your oncology device from first-in-human studies to larger pivotal global trials.
Our experience conducting in vitro diagnostics studies spans three decades. Chiltern continues to support complex diagnostics studies, mainly for premarket submission. We have supported studies in Asia-Pacific, Australia, Africa, North America and Western Europe with specific experience with breast cancer, chronic myelogenous leukemia, non-small cell lung cancer and systemic lupus erythematosus.
Just like it takes a team of mindful, knowledgeable people to get a trial up and running, it takes a full spectrum of services to support it. We continue to grow our extensive toolkit of services, vast storehouse of knowledge and global experience so we can continue to improve the quality of life for patients around the world and provide you a comprehensive oncology research support system, based on your needs.
- Biostatistics and statistical programming
- Data management
- Local and regional insight
- Market knowledge
- Scientific, tailored feasibility
Global Clinical Operations
- Clinical monitoring
- Clinical trial management
- Project management
- Development of regulatory strategies for investigational products and for diagnostics and devices
- Global regulatory submissions
- Interpretation of ICH, EU and FDA regulations and guidance
- Support for meetings with regulatory authorities
- Clinical development
- Medical writing
- Non-clinical development
- Global pharmacovigilance
- Medical monitoring