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With a successful track record covering a wide spectrum of cancer-related therapeutic indications, Premier Research provides high quality full clinical research services from small dose finding and proof-of-concept studies to large, multi-national trials involving hundreds of patients in this complex area of research. In the past five years, we have managed more than 120 clinical trials and 15 consulting projects contributing to a successful track record of completing studies on time and within budget. In addition to our comprehensive selection of services, we operate a dedicated specialty oncology clinic with an on-site oncologist that utilizes a central IRB.
 Experience Across Cancer Indications
Successful execution of oncology studies begins with a clear understanding of the tumor type to be evaluated, study design and analysis requirements, and the inherent challenges with conducting these complex studies. As shown in the chart above, Premier Research has substantial experience in all major types of cancers and this depth of experience means that Premier Research’s staff in all departments: monitoring, project management, data management, statistical analysis and medical writing, have a thorough understanding and familiarity with the tasks required to successfully complete oncology studies. We also have an extensive database of feasibility and previous study metrics to help assist us in the decision making process.
Our team has experience in specialized areas including tumor response assessment (RECIST, WHO response criteria), validated QoL questionnaires, and NCI Common Toxicity Criteria for AEs.
Expert Network
Premier Research has worked with many of the leading cancer centers and specialists in the United States and Europe. Over the years, we have built strong relationships with institutions that have conducted leading cancer trials allowing our sponsors access to a larger network of investigators and patient populations.
Patient Recruitment
Premier Research recognizes that there are unique challenges with patient recruitment for oncology trials. We have experienced oncology staff throughout North America and Europe that understand the factors that influence patient accrual. In addition, we can maximize access to large numbers of patients by targeting investigative sites in Central and Eastern Europe, where potential new treatment options encourage patients to participate in clinical trials resulting in rapid enrollment.
Clinical Trial Dynamics Unique to Oncology Trials
Given the devastating effect of cancer and the urgent need to find more effective therapies, the regulatory requirement for approving oncology products continues to evolve. As reported in the Wall Street Journal (July 10, 2006: FDA Signals It’s Open to Drug Trials That Shift Midcourse), FDA is encouraging Sponsors, particularly in the field of oncology research, to consider adaptive design strategies by providing a more efficient regulatory review and evaluation process. The rate of patient attrition, differences among supportive care and adjuvant therapy, coupled with the variable kinetics ascribed to treatment response are frequently exacerbated in oncology studies. Premier Research considers these trial dynamics when designing oncology trials.
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