Services

Data Management

GMCS provides unparalleled and comprehensive data management services for drug and device clinical studies using our Oracle Clinical data management system. And we offer clients options for EDC-related services by utilizing either Medidata Rave® or Oracle® Clinical for the collection of clinical data. The data management team consists of highly experienced and qualified staff with medical backgrounds which ensures us to provide superior data management services.

Clinical Data Management Services

We provide the superior data management services that include:

• Data management consulting
• Case Report Form (CRF) design, printing, distribution
• Data management manual/guidelines 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

Therapeutic Areas

Our data management staff provides services in a broad range of therapeutic areas (cardiovascular, renal, pulmonary, stroke, and metabolic, etc) for pharmaceutical, biotech and medical device communities. Most of our studies are global studies with sites in North America, Europe, Latin America, the Middle East and Asia.

Technical Environment

All systems used at GMCS are fully compliant with FDA 21 CFR Part 11.

We use Oracle Clinical V4.5.3 as a standardized platform for Phase II through Phase IV clinical trials. 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. 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.

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.

Quality Control

We go to great lengths to provide accurate, complete and reliable data to our sponsors. This is only possible through our thorough quality control system. We strive to attract and retain the high caliber, professionally skilled staff. Our data managers and data reviewers have graduated from established medical/pharmaceutical universities with 80% of them holding master degrees in medicine and/or pharmacy and have been engaged in clinical research for 15 years.

All of our staff receive formal training and updates in Good Clinical Practices (GCPs) and specific technical aspects of their job responsibilities. Once training is completed satisfactorily and documented, an employee commences their position under strict supervision and SOPs. All data management activities are conducted strictly to applicable guidelines and regulations, corporate global Standard Operating Procedures (SOPs) and, by request, sponsor SOPs.

For each project, we develop a data quality control plan to define the data quality level for a study, to design optimal data collection and processing so as to achieve the desired level of data quality, to measure and monitor data quality throughout the trial.