Precision Oncology provides unique, fully integrated solutions to support critical needs of companies in oncology drug development.
Through the more than 325+ oncology programs performed by Precision Oncology and the combined hundreds of years of oncology experience of our team, we offer sponsors our expertise gained through the experience of implementing some of the most challenging oncology protocol designs, including dose escalation and expansion studies, basket studies and other adaptive designs. It is with our company’s experience, true focus on study quality in oncology trials and a dedicated and well-retained staff that we offer our biotech and pharmaceutical sponsors a full suite of CRO services.
These services enable us to efficiently and expertly plan, manage, implement and analyze our sponsors’ oncology trials. Our qualified and committed Precision Oncology Site Network is an integral part of our expedient study start-up processes.
Site Selection and Patient Recruitment A key success factor in any clinical trial is the selection of the right sites. Proper site selection especially rings true for complex, early development oncology trials. Sponsors benefit from our Precision Oncology Site Network and the long-standing relationships we have developed with leading Investigators in a variety of oncology indications and phases of research. Our Precision Oncology Site Network key opinion leaders are available to provide critical input on trial design and feasibility based on their extensive and varied expertise and trial experiences. Read More
Clinical Monitors are the backbone to the success and quality of our clinical trials. Precision Oncology’s reputation for successful execution of the most complex clinical trials is predicated upon attracting, developing and retaining the best oncology development personnel, thus providing highly competent and consistent project teams for our sponsors.Read More
Experienced project management and efficient logistical planning are critical to the success of any study. With no resignations within our management team since 2000, Precision Oncology offers sponsors the assurance that their project is being planned and managed by a consistent and experienced project team. Our project management team has a passionate commitment to oncology research and strong expertise of standard and company-specific oncology research practices.Read More
Not only are positive results essential for a study’s success, but the quality of data is just as vital. In the case of oncology clinical trials, an even greater level of intricacy is present with respect to data collection and cleaning. Precision Oncology understands the importance of compiling and reporting quality data, and also possesses the expertise to traverse the complexity of an oncology trial, this is an absolute must for the success of your study.Read More
Precision Oncology’s safety unit is staffed with qualified and experienced safety specialists. All of our specialists hold health sciences degrees, and have experience in clinical research and/or clinical practice. Our safety team is closely supported by our medical monitors.Read More
Data Management Services
Precision Oncology offers our sponsors expert data management support by effectively leveraging the power of EDC systems. We appreciate the importance of compiling and reporting quality data and we possess the expertise to support of all our sponsors’ data management needs. Our highly trained Data Managers have significant experience in launching databases and managing data in multiple EDC systems including Medidata RAVE, Oracle InForm and MedNet and “home-grown” sponsor systems.Read More
Clinical Data Review Services
Precision Oncology’s clinical data review services provide rigor and quality assurance to the data clean-up process and enhance the predictability of finalization of end data and “lock” of the database for filing.Read More
Regulatory Compliance Services
Precision Oncology works with sponsors and sites to prepare for regulatory agency audits. The key to the success of any product is ensuring that the clinical trials and development programs withstand the rigor of an independent inspection. We provide sponsors with an impartial assessment to ensure compliance with the protocol, Standard Operating Procedures (SOPs), and regulatory guidelines necessary to verify the safety of study participants and the integrity and validity of study data. Quality and regulatory compliance assessments include various types of audits at multiple stages throughout a clinical development program. These assessments are necessary to ensure early detection of potential issues and allow for timely intervention and implementation of appropriate corrective actions without compromising data quality.Read More
Precision Oncology’s medical writing services are comprehensive throughout the lifecycle of your drug’s development and include...Read More
Expanded Access and Disease Registries
Precision Oncology has significant experience in supporting Expanded Access Programs for our sponsors as a pathway for patients to gain access to novel agents during the regulatory approval process. Our experts can design, implement and manage expanded access programs that provide patients treatment with novel agents while commercial approval is pending.Read More
Precision Oncology’s safety unit is staffed with qualified and experienced safety specialists. All of our Specialists hold health sciences degrees, and have experience in clinical research and/or clinical practice. Our safety team is closely supported by our medical monitors...Read More