Real-Time Data Management / Real-Time Data Analysis

Syreon ClinStream™ is designed to operate in support of and framed by regulatory-grade Data Management and Statistical Analysis Plans (DMP and SAP). Together, the DMP and SAP ensure the highest quality clinical data and analytical results to address the full range of study objectives. In combination with OLTP and OLAP functionality, ClinStream™ facilitates the use of advanced study methodologies such as sequential and adaptive trial designs.

OLTP

Syreon ClinStream™ supports on-line transactional processing (OLTP) functions with input of eClinical, eSource and ePRO data from many sources including physicians, providers, patients and other participants in the clinical research field. Data is checked for plausibility and concordance, and transmitted centrally using secure socket layer encryption. Queries are logged and reported to sites for immediate correction including person, time and reason for change consistent with the 2007 FDA Guidance for Computerized Systems in Clinical Investigation.

DMP

The DMP addresses the complete scope of data management activities, from the specification of case-report forms and the database, through data entry procedures and data validation rules at all levels of data processing activities.

OLAP

Simultaneous capability for on-line analytical processing (OLAP) enables real-time review of data completeness, consistency and variability, detection of outliers, review of safety indicators and blinded or unblinded reporting to the Data Safety Review Board, Scientific Advisory Committee, Executive Committee and Study Sponsor to ensure appropriate trial conduct, safety and progress.

SAP

The SAP formalizes the analytical methodologies required to address the research objectives of the project, from ongoing continuous monitoring of trial safety and efficacy outcomes through to adaptive trial methodologies, and final analyses and reporting.