CRAB’s most valuable resource is our dedicated staff. During more than 13 years of supporting oncology research, CRAB employees have remained focused on our mission. At the start of 2012, more than 50 of our approximately 85 employees have worked at CRAB for 5 or more years with 22 of those having been at CRAB 10 or more years. Another 10 members of our staff will reach the 10-year mark at the beginning of 2013. This longevity translates to solid knowledge of cancer diagnosis, disease processes, measurement and outcome; as well as to well-oiled collaborations.
A CRAB team is assembled for each research project. Each research team is manned by at least one person from each of the following areas: statistics, project management, data management , and when called for electronic data capture developers and clinical monitors. Each team works seamlessly from the start of a project through study publication. They design studies and contribute to study protocols; design, develop and implement customized electronic data capture systems, verify, clean and codify data so it is ready for analysis in real time. Within each discipline, CRAB employs strong training and mentoring approaches so that the work of all members of the team isis overseen by seasoned oncology research experts.
Statisticians: In addition to Drs Barlow, Crowley,Hoering and Qu (See expertise/biostatisticians.) 6 additional distinguished Masters level biostatisticians are employed at CRAB. Our statisticians are renowned for designing studies such that answers can be obtained. Once a study is activated the statisticians oversee the progress of the study, perform interim analyses and write Data Safety and Monitoring Reports before they perform final analyses preparatory to publication of the results.
To analyze data, biostatisticians use SAS® as the primary statistical package to analyze data which is primarily stored within an Oracle® database. SAS® is supplemented by associated in-house programs written using SAS, R and SPLUS® to perform data analyses. Common tasks include Cox regression analysis, Kaplan-Meier survival curves, statistical testing, recursive partitioning, and longitudinal data analysis. Applications used in microarray analysis include R and Bioconductor. A high speed computing system (HSCS) for genomics data analysis is used to analyze gene expression profiling (GEP) data.
Program manager office: Strong project management is an essential part of running a successful trial. CRAB’s Project Managers each have over 20+ years of clinical research experience and have worked on trials involving most types of solid tumors and hematologic malignancies. Our experienced Project Managers will work to implement your trial as quickly as possible and with high quality to meet your study needs and timelines. The PM’s will provide on-going communication to expedite every phase of the study and be your direct contact for your trial needs.
Data Managers: CRAB has 18 data managers with years of experience in oncology research ranging from 2 to nearly 30 years. Over half of the data managers specialize in therapeutic trials while the remaining specialize in prevention trials. Our data managers review protocols for consistency, assist with electronic data capture system creation, case report form design and cross field edit checks. They also define required elements for data collection as indicated in the protocol, and monitor trial enrollment and case report form submission. In addition, our prevention data managers are skilled at direct participant follow up via mailings and telephone calls.
Data Managers utilize and monitor an automated query tracking tool for missing or incorrect data as well as to write and manage additional data queries.
Other services include eligibility review, evaluation of treatment compliance, disease assessment, collection and monitoring of adverse and serious adverse events, and concomitant medication collection. A sophisticated evaluation tool allows data managers to enter derived data pertaining to each review category. These services complement the sponsor or clinical research monitor by providing timely review of submitted research data against protocol requirements. This in turn provides rapid, clean data for statisticians and data safety monitoring boards. CRAB’s method of centralized monitoring is in accordance with the FDA’s most recent guidance related to risk-based monitoring strategies.
Application Developers: CRAB’s Application Development team is comprised of approximately 20 people committed to building electronic data capture systems and other software to support cancer research clinical trials. We have dedicated teams for assessing business requirements, designing custom applications and databases, developing forms, building reports, help desk support, and a quality assurance group to insure the best software quality and security. Our team is highly experienced with many of us having 10+ years’ experience in software development as well as cancer research. This puts us in a unique position to build applications for a variety of cancer clinical trials and regulatory requirements.
Our application developers customize electronic data capture systems to the requirements detailed in the protocol. To collect data, our electronic data capture (EDC) system features a web-based user interface with field-level edit checks to ensure accurate data entry. Randomization and registration modules facilitate patient registration into appropriate trials and treatment regimens. A calendar tab enables clinical research coordinators (CRCs) to view, at a glance, the current submission status for a patient’s entire form set. User and site management is securely handled through role-based security with a user administration tool for setting user permissions. User accounts are valid across multiple trials. Study documents are readily available as needed. Lab normal values are included in lab reporting forms to ensure accuracy. Images (e.g., MRIs, PETs, CTs, photomicrographs, and X-rays) and associated data are transported to reviewers and collected in a central repository at CRAB using a secure imaging network.
Information Technology: A staff of 8 to 9 dedicated technologists secures and supports CRAB’s information services. The IT staff maintains workstations and servers and secures network services 24 hours a day, seven days a week. Skilled technicians utilize state-of-the-art technology to support applications for electronic data capture (EDC), data management and statistical analysis. The accomplish these goals while maintaining compliance with federal regulations that include 21 CFR Part 11 and FISMA.