Services

Data Management

GRS uses cutting edge data management technology that is globally consistent and 21 CFR Part 11 compliant. We provide you with comprehensive data management services for drug or device, from Phase I through Phase IV clinical trials. The Clinical Data Management Department consists of highly experienced and qualified staff to provide superior data management services with commitment to quality and timelines. GRS' Data Management staff is trained on multiple electronic data capture (EDC) platforms. We offer clients options for EDC-related services by utilizing either Medidata Rave® or Oracle® Clinical for the collection of clinical data. Both systems are designed to bring improved efficiencies in data capture and reporting to global clinical development programs.

GRS provides both data collection and full data management services through our Oracle Clinical system (V4.5.3). Our Oracle Clinical Data Management System includes Remote Data Capture (RDC), Oracle TMS (Coding System) and Oracle AERS (Safety Systems). Oracle Clinical is a powerful, comprehensive clinical data management solution which allows companies to standardize and control data definitions and data usage across a global operation, ensuring that data is defined, managed, and interpreted consistently worldwide and in real time. It can manage large volumes of patient data collected during clinical trials. This expedites the multinational regulatory approval process and reduces cycle times in critical clinical trial processes, thereby accelerating time to market for new products.

GRS offers the ability to collect CRF data using RDC and paper either individually or in tandem to accommodate sites. Our staff determines the services required for your project, prepares mutually agreed-upon timelines and ensures accurate and on-time completion of all data management activities that include:

Data management consulting
Case Report Form (CRF) design, printing, distribution
Data Management Plan development
Database design and development
Data receipt, logging, and tracking using Clinical Trial Management System (CTMS)
Data entry
Data validation and cleanup
Medical coding (WHODrug and MedDRA)
Data quality assurance
Data Management reporting
Secure central lab electronic data transfer and upload
Electronic Data Capture (EDC) implementation and site training and support
CDISC datasets

We strive to attract and retain the highest caliber, professionally skilled staff. Our data managers and data reviewers have medical/healthcare backgrounds and have been engaged in clinical research on average for 15 years. All of our staff have been trained in Good Clinical Practices (GCPs). All data management activities are conducted strictly to applicable guidelines and regulations, and corporate global Standard Operating Procedures (SOPs). We go to great lengths to provide accurate, complete and reliable data to our sponsors.

Private Label Reserve (PLR)

An innovative business model for Phase I Units and other service providers - GRS offers our data management services to other organizations to be their comprehensive clinical data management service center.

For those organizations that would benefit from offering high-end data management services to their own clients, GRS can be your private behind-the-scene data manager to help you with expanded data management services. GRS' Private Label Reserve partnership allows your site access to a premier remote data capture (RDC) system, as well as a comprehensive library of Case Report Forms (CRFs), a complete "behind-the-scene" data management staff, creation of data collection screens, site training, and finally the management, analysis and reporting on your data for your clients all under your own name.

Benefits of Private Label Reserve:

Access to a fully integrated data management system that supports paper CRFs or RDC, safety events and coding of drugs
Access to an experienced "behind-the scene" data management team dedicated to serving the clinical trial industry
"User-Friendly," real time data entry in to Secure Site (from wireless PC at the bed site, if appropriate)
Personalized Data Portal used for demonstrations to your customers
A library of standardized Case Report Forms (CRFs) to use in building your database
24-hour Help Desk (Monday through Saturday)
Project staff training
Access to a panel of reporting tools for tracking project management and site level milestones, data, status and audit trails
Electronic data capture (EDC) that maximizes speed, performance, accuracy and cost effectiveness
Additional value-added service for your clients and a new revenue stream for you