Innovation, commitment, passion, actionable data, and fast decisions are mandatory if clinical development is to keep pace with scientific knowledge in oncology and advance the right treatments to the right patients.
Your clinical development team is dedicated to meeting the significant unmet need in cancer therapies. You’re busy evaluating ever more targeted and powerful medicines, designed to stop cancer in its tracks. You’re committed to running more precise and less empirical clinical studies to maximize patient opportunity and accelerate drug development cycles. You recognize that “business as usual” in oncology drug development is simply not sustainable.
We’re right with you. We match and understand your drive and passion to advance the next generation of safer, more effective medicines to the patients who desperately need them.
We have the medical and operational expertise that you can trust to successfully engage the investigators and patients you seek to deliver your clinical studies on time and on budget. As your CRO, we work collaboratively with you, providing customized and thoughtful study or program-specific solutions.
We have the manpower your clinical trials need
With over 700 oncology specialists and experience in over 70 countries worldwide, we provide the resources with the local clinical and regulatory knowledge to support complex international clinical studies. From CRAs to Project Managers to Medical Directors, each member of our clinical development team works exclusively in oncology, providing you with unparalleled expertise.
We develop unmatched site relationships
We have formed expert-to-expert relationships with known, trusted sites by mirroring investigator interests in specific tumor types and development stages. This alignment of knowledge, science, and commitment assures sites and sponsors that they have a CRO partner working on site that’s acutely aware of the specific needs of the trial and already understands the implications of those needs on the site and the patients. From day one we’re positively engaged with the right sites targeting the right patients, helping you meet your recruitment targets no matter how complex your trial. Our strong site relationships generate time, cost, and operations benefits evident to both the sponsor and to the site.
You can clearly see how we work for you
We are constantly improving our data systems and connectivity while leveraging our therapeutic and operational experience to enhance how we use these tools. Our systems enable us to place empowering real time data directly into the hands of the clinical team and the customer – information that allows for the execution of intricate oncology clinical trial designs and risk-based monitoring approaches. Management and on-time, on-target delivery of complex oncology trials involving thousands of patients and sites worldwide requires established metrics-driven processes and proven therapeutic depth, demands that only INC can meet.
We provide specialized clinical development consulting services
Our experts will work with you to achieve the ideal design and clinical development plan for your oncology clinical trials. Our therapeutic strategy leads and medical directors routinely provide our customers with the foresight and guidance to ensure their clinical trial design is scientifically sound, attractive to patients and investigators, and stands the best chance of demonstrating clinical and commercial value.
We’re forward thinking
Targeted and combination therapies, companion diagnostics, immunotherapies and the protocols designed to test them are reinventing the clinical landscape in oncology. We are actively working with this leading edge science and are implementing improvements in our processes and data tools to meet the demands of the shifting research paradigm. Our staff and systems are proven and capable of handling all types of oncology clinical trials: first-in-man, combined Phase I/II, transition/”rescue” studies, global pivotal registration studies, and even studies with special regulatory designations, such as “Breakthrough Therapy” and “Fast Track”.
Oncology clinical studies are no challenge
Our oncology teams hit the ground running; our combined experience from over 600 oncology studies can support efficient conduct of trials that safeguard patients and generate meaningful data based on the latest scientific thinking.
We supply focused teams to address your unique oncology clinical trial challenges
First-in-man oncology clinical studies are uniquely different from any other clinical study; liquid tumor work is vastly different from solid tumors. Proficiency within each oncology specialty is needed to achieve your desired outcomes. That’s why we’ve structured our business into sub-specialty teams organized to concentrate our therapeutic expertise and apply it to achieve the most efficient project delivery on your study.
We have extensive first-in-patient experience with novel oncology drugs and unprecedented study designs in Phase I and I/II studies. Our Early Phase team has the dedication and flexibility necessary to adapt to course changes inherent in early phase oncology drug development. We take your trials from Phase I to Phase II and beyond with minimal burden to patients and sites, ensuring consistent data and smooth expansion. To find out more please download our brochure from the link on the right.
Hematology-oncology clinical trials
General clinical development expertise doesn’t naturally translate to hematology-oncology studies. A CRO with specific, tangible experience in leukemias, lymphomas, and rare hematology-oncology tumors is essential to success. When you work with us, it’s not just access to hematology-oncology experts that you get. You can be confident that your project team is accustomed to managing the complex study designs, patient recruitment challenges, and specific issues surrounding unique mechanisms of action in this segment. We’ve done it all, from the first Phase II study for a molecule through critical Phase III global registration trials for landmark therapies.
We have measurable global experience and unmatched expertise in providing an extensive range of clinical development services in this underserved segment. Our focused team has demonstrated capabilities in major diseases, such as hemophilia and anemia as well as rare conditions, including von Willebrand disease and Idiopathic thrombocytopenic purpura (ITP).
The treatment paradigm for many types of solid tumors is quickly changing. Staying abreast of the latest scientific advancements, such as immunotherapies, is a massive task. We understand the rapid advancements in late phase solid tumor drug development and how they will shape the way your study is designed and executed. Giving your studies the greatest chance of success will require an experienced, skilled CRO project team as focused as the science. With so much change to manage during the course of your trial, you can rely on the solid tumor experts at INC Research to guide you through the challenges you can see, and those just over the horizon.
As a market-leading CRO, we have the manpower, expertise and experience to help your oncology clinical trials succeed. To find out more please download our brochure from the link on the right.
Our Experience is broad
With over 600 oncology studies worldwide under our belt, we’ve completed studies in over 60 classifications of major and rare cancer types and non-malignant hematology conditions. Why not download our oncology fact sheet for the full list of indications we’ve worked on?
In addition to our experience across a broad spectrum of tumor types, we are currently working with the next generation of investigational therapies. We have personally performed studies on a wide range of therapeutic approaches to treating cancer, including:
- Cytotoxic agents
- Gene therapy
- Toxicity and efficacy modulators
- Monoclonal antibodies
We also know how to go beyond the science and work to meet the global regulatory requirements for getting novel compounds approved. In the past five years, we’ve conducted almost 30 studies that directly factored into the approval of 10 new oncology/hematology therapies.
We have extensive experience in running studies with molecules granted special regulatory designations, such as “Breakthrough Therapy”, “Fast Track”, and “Accelerated Approval” statuses. Specifically, we’ve worked with 13 molecules with 25 special designations. INC has managed 34 studies across 16 indications in this unique area of innovation.
We’ve also managed over 60 studies since 2011 with compounds designated as “Orphan Drugs”.
Many of the studies in our repertoire involve biomarkers, diagnostics, and pharmacogenetic sampling and testing strategies. Every day we are meeting the challenges and managing the complexities of modern trial design. We look forward to meeting your team, rolling up our sleeves, and getting to work.
a This is an estimate of INC Research studies from the last five years that are completed or scheduled to complete for this therapy area.