Data Management

Not only are positive results essential for a study’s success, but the quality of data is just as vital. In the case of oncology clinical trials, an even greater level of intricacy is present with respect to data collection and cleaning. A CRO that understands the importance of compiling and reporting quality data, and also possesses the expertise to traverse the complexity of an oncology trial, is an absolute must for the success of your study.

With an average of 8 years of oncology clinical trial experience, Prologue Data Managers understand your challenges.

They are involved at the start of a project with CRF development, data collection guidelines, database specifications, and edit design and testing. Clinical Data Managers continue their involvement with the coding (including: MedDRA, WHOART, COSTART, WHODrug), evaluation, analysis, and report review stages to provide insight and enhance deliverable quality. Data management activities begin with a draft protocol and are performed in collaboration with other departmental and sponsor team members to define the data collection, cleaning and reporting process. Our team of database programmers is experienced in SAS, SQL Server, and Oracle and provides live access to the clinical data through a secure web portal (ProLink) 24 hours a day, 7 days a week. We also support CDISC and customized data exports to meet the various needs of our clients. Clinical database solutions include paper-based, fax-based, and EDC-based systems.