Clinical Trial Services

CRAB provides an efficient and seamless suite of clinical trial services from inception of the study to publication of the results. Our statisticians design studies such that the key questions can be answered unambiguously. They work with Data Monitors and Applications Developers to create an Electronic Data Capture system that will capture data necessary for the trial. Project managers oversee the entire process to assure the study is on time and on budget. Once the study is activated our Data Managers use this powerful EDC system to perform centralized monitoring of the data in real time, assuring the data are clean, complete and accurate through resolution of queries. Our approach to centralized data monitoring reduces the need for on-site clinical monitoring except in trials requiring FDA approval. Statisticians provide interim analyses, DSM reporting and support, final analyses and writing for publication.

PRE-STUDY ACTIVITIES
Study Design
Protocol Development and/or Review
Electronic Data Capture (EDC) System click for more information

The CRAB Electronic Data Capture (EDC) System provides Web-based electronic case report forms for secure encrypted transmission of trial data meeting compliance with 21 CFR Part 11 requirements. CRAB’s EDC is globally accessible with near 24/7 availability and features optional customization of forms to fit your trial.

Study Management Features

User and Site Management: Our Web Administrative Module provides quick and easy entry of user and site information. As an option, user accounts may be managed across multiple trials.

Calendar Tab*: At the click of a mouse, CRAB’s Calendar Tab provides a view of all study forms that need to be submitted or updated for a subject in a centralized location. Information about forms is summarized on the Calendar Tab and includes hyperlinks to related locations in the EDC system.

Study Arm Administration*: Authorized users open and close study treatment arms to further enrollment using CRAB’s Study Arm Administration tool. This tool is often used in phase I and phase I/II studies with treatment doses with a small target enrollment goal per dose (often 3-6) when adverse event data indicate that a treatment arm should be closed early.

Study Documents/Magic Folders*: Password-protected access is provided to important study documents. CRAB’s EDC uses “magic folders” which provide our project managers with an easy-to-use method for posting documents in real time by simply adding the files to site folders. Document posting may be automated when immediacy is required.

Team Portal*: Clients with multiple trials may also request a branded Team Portal where site staff and collaborators can access trials and a wide variety of documents and reports.

Patient Data Management Features

Randomization/Registration: New subjects are easily registered within our web-based EDC. Our system is capable of tracking subjects in screening and screen failures, and quickly performs subject randomizations. CRAB’s randomization algorithm can handle multiple stratification factors, and different weights may be assigned to each factor.

Automated Query Tracking System/Query Manager: The query system provides Automated Query Tracking for generating, displaying, resolving, and tracking queries generated from apparent anomalies discovered by the EDC system or by study personnel. Study personnel may generate queries manually by using the Query Manager tool. Query requests are sent to sites, sponsor-investigators, central pathologists, and central imaging reviewers for clarification of apparent errors or inconsistencies in their data. Recipients are expected to answer all of the queries they receive.

Lab Limits of Normal: The CRAB EDC allows users to enter the lower and upper limits of normal for tests done on study in a centralized location thereby reducing the need for unnecessary duplicative data entry.

Patient Evaluation Program (Eve): The Patient Evaluation Program (Eve) is utilized by our central monitoring staff to enter and manage derived variables that are used by our statisticians in study analysis. This tool also enables our staff to track any serious adverse events (SAEs) or dose limiting toxicities (DLTs) that were reported in the EDC system.

Dose Limiting Toxicity (DLT) Reporting*: Phase I and Phase I/II studies that involve dose escalation often track dose limiting toxicities (DLTs). For these studies, adverse events reported in the EDC system that match a protocol’s DLT criteria are automatically labeled as a suspected DLT. Reports listing these suspected DLTs are provided to study personnel for additional follow-up and categorization. The immediacy of this safety reporting allows investigators to contemplate running multi-institutional Phase I, and Phase I/II trials.

Medical Imaging*: Our Medical Imaging services provide a secure way to track and archive medical images throughout the life of trial. We support multiple image formats and can merge image data with other clinical data for analysis.

The CRAB EDC also features metadata-based forms creation, a practice site, and integration with other systems (randomization, billing, imaging, etc.). Please contact CRAB to discuss how we can work together to meet your electronic data capture needs.

* Optional features which can be added to enhance data collection and study management.

Clinical Feasibility Assessment and study start up services
ACTIVE STUDY SERVICES
Project Management
Data Management click for more information

At CRAB, we believe the collection, monitoring and management of data are crucial to quality research and science. We offer the following data management services:

Data Selection: We provide guidance related to what information should be captured on electronic case report forms or collected via separate applications (such as specimen tracking) to meet your research objectives.

Data Collection: CRAB has an established, well defined Electronic Data Capture (EDC) System that reliably and consistently collects the data you require for your study. We offer customizable electronic case report forms.

Data Review: Centralized monitoring as recently defined in the draft FDA Risk-Based Monitoring Guideline is our specialty. We will assure that studies meet statistical requirements and study objectives by verifying adherence to study guidelines for eligibility, treatment administration, treatment response and safety reporting. Our in-house data managers/monitors are skilled at identifying incongruities not found by edit checks alone. Data Metrics: We build and deliver reports critical to the overall management of your study.

Data Protection: Our state-of-the-art Data Center keeps your electronic data safe and secure at all times. In addition, we routinely back-up your data to an off-site location as part of our disaster preparedness plan.

Please contact CRAB to discuss how we can work together to produce reliable and valid results for your research project.

Serious Adverse Event reporting
Interim Statistical Analyses and Data and Safety Monitoring support
Regulatory support
Monitoring click for more information

Cancer Research And Biostatistics (CRAB) provides monitoring services in accordance with FDA regulatory requirements and Good Clinical Practices guidelines. CRAB’s monitoring and site management services include: Site Qualification/Selection Visits: During the site selection process, CRAB conducts on-site visits to verify that the site and investigator are qualified and have appropriate resources to conduct the clinical trial.

Site Initiation Visits: Site Initiation Visits provide the investigator and site staff with the training necessary to conduct the clinical trial. Clients may opt to select on-site or webinar Site Initiation Visits.

Clinical On-Site Monitoring: Our experienced monitors provide on-site visits to conduct source document verification to confirm eligibility, consent and accurate submission on case report forms. Monitors perform investigational product accountability, review regulatory documents and review clinical trial conduct at the site to ensure protocol adherence and subject safety.

Centralized Monitoring: CRAB has years of experience in providing Centralized Monitoring as defined in the recent draft guidance issued by the FDA regarding Risk-Based Monitoring. Our statistical center data management staff review the case report forms submitted in our electronic data capture (EDC) system for consistency, accuracy and to ensure statistical requirements and study objectives are being met.

Hybrid Monitoring: CRAB offers a risk-based model of monitoring that merges the review of the on-site monitors with the centralized monitoring conducted by the data management staff. Using a risk-based targeted monitoring approach, monitors focus on data elements related to study objectives, eligibility, and study subject safety. Monitors and statistical center data management staff work in tandem to ensure a high quality and comprehensive review of the clinical trial data.

Remote Monitoring: CRAB offers an innovative monitoring service performed by the statistical center data management staff that includes a risk-based assessment of the clinical trial’s complexity, endpoints and safety evaluations. Based on this review and with input from the sponsor, specific types of source documents are collected from the site. Remote monitoring is performed in conjunction with centralized monitoring to include a certain degree of source document verification without the addition of an on-site monitor review.

STUDY CLOSEOUT SERVICES
Statistical Analysis
Publication of Results