Data Management & Statistical Analysis

Given a random variable (blue), the standard deviation is a measure of the spread of the values of the random variable away from its mean.

One can easily discern a trend away from ‘data’ to ‘information’ and ‘knowledge’. There exists not only data management, but also information management and knowledge management. While data can exist as such, information and knowledge can only be measured in relative terms. There is an extremely relevant distinction between data and derived values.

The full data lifecycle needs of your clinical research project are nourished by the architectures, policies, practices and procedures developed and executed under genae’s ISO-9001 certified data resource management.

All data is secured. It is kept safe from corruption and access to it is controlled on multiple levels.

Trials conducted with paper or electronic CRFs need several databases. genae’s Database Management System is designed for the purpose of managing these databases, based on a variety of data models.

Our well-trained data handling department performs data entry and verification. Automated checklists and error checks generate edit queries and data clarifications. Industry standard Electronic Data Capturing (EDC) technology is deployed for e-CRF projects.

The statistical department is experienced in the analysis of clinical trial data in general and in advanced statistical methods for power calculations, interim & final analysis and stopping rules in specific. Our ability to link databases from the core lab with the trial databases results in an unsurpassed data pool for strategic, scientific and marketing decisions.