Clinical Research Data Management

Innovative Clinical Research Solutions offers complete clinical research data management services tailored to your specific study requirements and expectations. Our expertise extends from initial protocol review to data lock and statistical analysis. We provide extensive study development services and offer a wide range of clinical research data management services throughout the course of your clinical trial, including protocol review, Case Report Form development, ongoing data management, safety monitoring, and regulatory reporting.

Data Management Process

During the development phase, ICRS works closely with the PI and study team as we review the protocol, develop the schedule of assessments, create the Case Report Forms, and program the Acquire™ EDC clinical research database and data entry screens. Prior to subject enrollment, we conduct complete training in the use of the system, tailored to the unique features of the protocol and CRFs.

Once the trial is underway, our clinical research data managers review data daily, and query study coordinators via Acquire's HIPAA-compliant integrated query system, so that no PHI data is ever sent in unsecured email. We also coordinate with third parties to get external data (such as laboratory results) imported into the study database to eliminate burdensome, error-prone data entry.

Data Management Value

Our clinical research data management services include a full array of study management reports which allow study personnel the ability, at any time, to download their own data into Excel for further analysis. Custom study management reports are also available. With the Acquire™ EDC system, the Principal Investigator and study personnel have all of the tools necessary to guarantee valid and clean data for their study analysis.