Services > Research Teams

We work to ensure the most optimal trials

CRAB’s most valuable resource is our dedicated staff. 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. The longevity of CRAB employees translates to extensive and intuitive knowledge of the optimal steps to take to result in impeccable research.

Based on the indication and requirements, we assemble a research team tailored for each project. Every research team includes at least one professional from the following areas: biostatistics, regulatory, project management, data management, electronic data capture development and clinical monitoring. The teams work cohesively from the start of a project through study publication: designing studies, contributing to study protocols, developing and implementing customized electronic data capture systems, and verifying and cleaning data so it is ready for production of the statistical analysis.

CRAB’s biostatistical team includes distinguished Doctoral and Masters level biostatisticians. Our statisticians are renowned for designing studies to obtain accurate and reliable answers. Once a study is activated, the statisticians oversee the progress of the study, monitor data cleanliness, perform interim analyses, and write Data Safety and Monitoring Reports before performing final analyses supporting publication of the results.

To analyze data, biostatisticians use SAS® as the primary statistical package to analyze data. SAS® is supplemented by associated in-house programs written using R to generate statistical outputs. Common analyses include Cox regression analysis, Kaplan-Meier survival analysis, 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 ensuring an efficient trial. CRAB’s Project Managers have experience on trials involving almost all types of solid tumor and hematologic malignancies. CRAB Project Managers work to implement your trial as quickly as possible, ensure high data quality and meet study budget and timelines. Our project managers provide on-going communication to expedite every phase of the study and are the point-person for sponsors and Principal Investigators.

Project managers bring together a full range of services and experience to meet our clients' needs. Depending on our clients' needs and experience, we tailor our team and approach. Project management tasks available for a study include, but are not limited to:

  • Overall clinical study management
  • Management of high-level timelines/milestones
  • Site start-up activities
  • Primary contact for all trial related activities
  • Regular reports/updates on budget

CRAB has approximately two dozen data managers with yearsof experience in oncology research. 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.

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 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

CRAB monitors are dedicated research professionals who provide quality clinical monitoring services for their clients. To ensure the clinical trial is conducted according to the protocol and good clinical practice guidelines, our monitors provide on-site review of:

  • Regulatory documents
  • Drug accountability records
  • Data queries
  • Case report forms
  • Source documents

Subject charts are closely reviewed to confirm eligibility and protocol compliance. In addition, site monitors provide on-site training to clinical research 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. 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 (EDC) systems and other software to support cancer research clinical trials. We have dedicated teams that:

  • Assess business requirements
  • Design custom applications
  • Design and implementing databases
  • Develop forms
  • Building reports
  • Provide help desk support
  • Provide effective quality assurance to ensure software quality and security

Our team is highly experienced, with many having 10+ years’ experience in software development and cancer research. This places 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, we utilize Medidata Rave® for the latest SWOG trials as well as have a proprietary data capture system, CRAB Nebula™. Both systems feature 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.

CRAB Nebula includes a calendar tab to enable 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 establishing 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 dedicated technologists – systems engineers, systems and network administrators, database administrators, helpdesk specialists, and project manager – secure and support CRAB’s information services. Our IT staff maintains workstations and servers and secures network services 24 hours a day, seven days a week. These experienced technicians utilize state-of-the-art technology to support applications for electronic data capture, data management and statistical analysis. They accomplish these goals while maintaining compliance with federal regulations that include 21 CFR Part 11 and The Federal Information Security Management Act (FISMA).