CRAB’s most valuable resource is our dedicated staff. During 20 years of CRAB supporting oncology research, employees continuously are focused on our mission. At the start of 2017, 48 of our approximately 85 employees have worked at CRAB for 5 or more years, with 36 of those having been at CRAB 10 or more years and 12 employees for 15 or more years. Another 8 members of our staff will reach the 15-year mark at the beginning of 2018. This longevity translates to solid knowledge of cancer diagnosis, disease processes, measurement and outcome; as well as to strong interoffice 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 is overseen by seasoned oncology research experts - click on each group below to learn more.
In addition to Drs. Barlow, Crowley, Hoering and Qu, six 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 analyses. Applications used in microarray analyses include R and Bioconductor. A high speed computing system (HSCS) for genomics data analysis is used to analyze gene expression profiling (GEP) data.
Strong project management is an essential part of running a successful trial. CRAB’s Project Managers (PM) 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 PMs will work to implement your trial as quickly as possible and with high quality to meet your study needs and timelines. The PMs will provide on-going communication to expedite every phase of the study and be your direct contact for your trial needs.
We view our clients as partners with CRAB. We translate this philosophy into action within our project management team. Our PMs bring together a full range of services and experience to meet our clients' needs. We provide services to our clients from large pharmaceutical companies and consortiums to small startups. Depending on our clients' needs and experience, we tailor our team and approach. Our clients benefit from many years of experience with both oncology clinical trials and project management. We have demonstrated our ability to successfully support the launch of First-in-Human studies through pivotal Phase III global clinical trials.
At CRAB, our PMs are responsible for the overall conduct of a clinical study. Our managers not only ensure your project is on time and on budget, they provide you with high quality support from beginning to end. Project management tasks available to your study include, but are not limited to:
- Overall clinical study management
- Management of high-level timelines/milestones
- Development of customized eCRFs for data capture
- Site start-up activities
- Primary contact for all trial related activities
- Regular reports/updates
CRAB has 18 data managers with years of experience in oncology research ranging from two 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 and 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.
Cancer Research And Biostatistics (CRAB) provides clinical monitoring in accordance with FDA regulatory requirements (21 CFR part 312.50 and 21 CFR part 312.56) and Good Clinical Practices guidelines. CRAB’s monitors are experts in the field of data management and oncology research.
Monitoring visit services include:
- Pre-study/site qualification visit
- Site initiation visits
- Interim monitoring visits
- Close-out visit
CRAB’s monitoring experience spans all types of trials from large-scale prevention studies, to Investigator-initiated/sponsored studies (IIT/IST), to Phase I-IV industry sponsored trials.
Our monitors provide on-site review of regulatory documents, drug accountability records, queries, case report forms and source documents to ensure the clinical trial is being conducted according to the protocol and good clinical practice guidelines. Subject charts are closely reviewed to confirm eligibility and protocol compliance. In addition, site monitors provide on-site training to site staff as needed and requested, to ensure compliance with protocol and study procedures. Detailed reports are provided to both the client and site investigator at the conclusion of each visit.
CRAB monitors are dedicated research professionals who provide quality clinical monitoring services for their clients. Our monitors work closely with project and data management team members at CRAB to ensure each client’s regulatory and compliance requirements are met with success and satisfaction.
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.
A staff of nine 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. They accomplish these goals while maintaining compliance with federal regulations that include 21 CFR Part 11 and FISMA.